Flu in other species a worry
Scientists study effect of H1N1 spreading to pigs, birds
By HELEN BRANSWELL The Canadian Press
Sun. Aug 23 - 4:45 AM
http://thechronicleherald.ca/Canada/1138985.html


TORONTO — With swine flu viruses now showing they can infect humans, pigs and turkeys, scientists will be looking closely for genetic evidence of whether the viruses change in potentially dangerous ways as they pass from one species to another.

Unfortunately, the first known case where the virus likely passed from people to pigs back to people won’t provide any answers.

The head of Canada’s National Microbiology Laboratory has revealed his lab couldn’t isolate viruses from respiratory specimens collected from two federal employees who became infected while investigating an outbreak of the novel H1N1 virus on an Alberta pig farm.

Though the two Canadian Food Inspection Agency inspectors tested positive for the pandemic flu virus, lab technicians would have to have found live viruses in their specimens to be able to compare them to those of viruses isolated from pigs on the farm and from other humans.

"We weren’t able to isolate virus from what we got. So we haven’t really sequenced anything," Dr. Frank Plummer said in an interview Friday.

"It’s too bad, but I think that’s just the way it is."

It’s not uncommon that specimens don’t yield viruses for study. But in this case it is unfortunate. Scientists would have liked to have seen whether the cycling through different species created changes in the viruses — and what kind of changes.

"It absolutely would have been very interesting," said Plummer, who admitted without live viruses "there’s nothing really more to be done."

The pandemic virus was first found in people in mid-April. Late this week officials in Chile announced they had found the virus in turkeys — a species known to be susceptible to influenza viruses.

Though it is largely comprised of swine influenza genes, there is no evidence the virus is spreading in pig populations or that pigs are fuelling the spread among humans. In fact, in the handful of cases where the virus was found in pig herds — in Canada, Argentina and Australia — the presumption has been that people have infected pigs, not the other way around.

The first such case occurred in mid-to-late April in Alberta, on a pig farm near Rocky Mountain House.

It’s not known and may never be known who introduced the virus into the pig population, but CFIA believes the source was human.

And the agency also believes two of its inspectors who investigated the outbreak and came down shortly thereafter with swine flu picked up the virus in the piggery.

The men admitted they took off their protective equipment because they were hot.

As for the viruses isolated from the pigs, the National Centre for Foreign Animal Diseases — the animal counterpart to Plummer’s lab — is continuing to study the genetic sequences of those viruses.

But the lab’s director, Dr. Soren Alexandersen, said the isolates don’t seem to contain any significant changes when compared to the genetic sequences of the viruses circulating in people.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Southern Hemisphere's swine flu experience holds hints of what may be ahead
By Helen Branswell (CP)
http://www.google.com/hostednews/ca...qtPTyjcYfLFthbg


TORONTO — When a new, unheralded flu virus startled the world last spring by igniting the first pandemic in four decades, public health authorities in the Northern Hemisphere knew they'd caught a bit of a break.

While the virus seems to have started its journey in this part of the world, and caused a lot more illness than one would expect throughout our summer, the pandemic didn't start in peak flu transmission season.

The first real test of how the new H1N1 virus behaved in winter conditions would fall to the Southern Hemisphere. And the countries of the North could watch, learn, plan and fast-track vaccine production.

With winter now on the wane south of the Equator, experts are sifting through the experiences of temperate countries there looking for signs of what this new virus might have in store for the fall and winter of 2009-10 in northern countries.

There are few givens with notoriously unpredictable flu viruses. Still, experts say, so far this virus has carved a path and hewed closely to it.

"By and large it's been incredibly consistent across countries," says Sonja Olsen, an epidemiologist who co-ordinates a number of emerging infectious disease programs run by the U.S. Centers for Disease Control in places like Thailand, Kenya, Guatemala and Bangladesh.

"Obviously every country has different surveillance approaches, so factoring in that you can't necessarily do direct comparisons. But I think that looking at the various aspects that we've been interested in the disease, it's strikingly similar to what we experienced in the spring."

Influenza experts at the World Health Organization are focusing on the experiences of the temperate countries - New Zealand, Argentina, Australia, Chile and South Africa - to assess the pandemic virus's behaviour in its first true winter. Those are also the countries with the best flu surveillance systems in that part of the world.

Flu behaves differently in tropical countries, explains Dr. Anthony Mounts, an expert with the WHO's global influenza program. In the tropics flu peaks a couple of times a year, but at neither point is there as much flu activity as is seen during a true winter wave such as Canada or the countries of Northern Europe experience.

"Winter facilitates spread of influenza for whatever reason. And that seems to be what we've seen," Mounts says from Geneva.

As it did in the North in the spring and early summer, the virus spread quickly in the parts of the Southern Hemisphere where surveillance systems are strong enough to track it.

The sole exception seemed to be South Africa, where initially seasonal flu viruses predominated. Olsen says that may have been because the virus was introduced there later, after seasonal flu activity had already begun. Whatever the reason, when swine flu took off in South Africa it spread as efficiently there as it has elsewhere.

The virus appears to have sent hoards of people to their beds, but few - in percentage terms - to the hospital.

The pattern seems to mirror precisely what was seen in parts of North America this spring and early summer. In the majority of cases, people had what seemed like regular flu. But in a small fraction of the infected, the virus's attack on the lungs was so severe that patients ended up in intensive-care units, fighting for their lives.

These folks were, generally speaking, decades younger than those who are hospitalized with seasonal flu. And doctors who treated them reported they were profoundly ill and enormously difficult to treat. And they stayed that way for prolonged periods, jamming ICUs.

"You talk to ... people who run intensive-care units, and they'll describe situations they've never seen before, with half of the intensive-care unit taken up by people with pandemic flu," Mounts says.

That is the type of thing for which Northern Hemisphere countries need to be planning, he says. "What's going to be the total impact on our health-care system? What do we have to be prepared for?"

In the Southern Hemisphere, care of these patients has taxed the ICU units of hospitals in areas badly hit. And in a few cases which garnered a lot of media attention in Australia, a couple of patients had to be flown to other centres to find available ventilatory care. In at least one hospital in New Zealand, elective surgery was reportedly suspended because there were no free ICU beds.

But for the most part hospitals have managed, Mounts says.

"It wasn't, I think, overwhelming to people, to the system. It wasn't that intensive-care units were putting people in the hallway. It's just that they were really busy. And the hospitals were really busy."

The former head of Australia's WHO influenza collaborating centre agrees.

"It hasn't been overwhelming as people had feared," says Dr. Ian Gust, a professor of microbiology and virology at the University of Melbourne. "In the main the system has coped pretty well, I think."

Some other things are coming into focus from study of the Southern Hemisphere winter.

The new virus appears to be crowding out the two seasonal influenza A viruses that have been circulating in recent decades.

"By and large I would say that this is now the dominant virus among influenza viruses," Olsen says. But she and others note it's too soon to say whether the other two influenza A viruses will disappear, as happened in previous pandemics.

Older adults do indeed seem to be largely spared. Though the CDC reported early in May that people over 60 might have some immunity to the new virus, some experts wondered if the paucity of older cases related more to the circles in which the virus first started circulating - younger travellers and school-aged kids and teens - than innate immunity.

But it is seeming more apparent that older adults are less vulnerable to this virus. That said, those who do catch it seem to be more likely to die from the infection than people in their 20s or 30s.

"Your total numbers of deaths in that age group is likely to be lower. But if a person of that age is infected, his outcome is likely to be worse. ... That seems to be consistent as well," Mounts says.

Genetic analysis of the viruses continues to show very little change among them. While that surprises some observers, others suggest that is a sign the virus doesn't currently need to mutate - it is having no trouble finding susceptible respiratory tracts.

So does all this suggest the virus will dole out more of the same for the Northern Hemisphere this fall and winter?

"I just don't think we can predict," Olsen says. "It's helpful to know that things have been fairly consistent. But I think we don't know."

"I think we have to be prepared for a number of different scenarios and be prepared for the unknown, essentially."

The WHO remains worried, Mounts admits. "I think because of the coming winter season in the Northern Hemisphere we're all kind of on edge. And feeling a lot of pressure to sort out what happened in the South so we can be prepared."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Intensive care units likely to be main battlegrounds in the war against H1N1
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...ihXsJonKx7DLK2Q


TORONTO — Intensive care specialists who fought to save desperately sick swine flu patients this spring and summer have a warning for hospitals that haven't yet dealt with an influx of these difficult-to-treat patients.

Prepare. Now. Experts predict ICUs are likely to be the main battlefield in the war against a pandemic virus which so far doesn't appear to have much of a middle ground.

The vast majority of people suffer through a typical bout of flu. But of those who become sick enough to be hospitalized, a significant portion - maybe as high as 15 per cent, the World Health Organization says - end up in ICUs for weeks, hovering between life and death.

"I've never seen this," says Dr. Paul Hebert, editor of the Canadian Medical Association Journal and an intensive care physician in Ottawa who has treated several of these patients.

"As an ICU doctor, it's very, very, very rare I can't deliver enough oxygen to someone to keep him alive. They die of other things, right? They die because their organs fail."

"In this case, we can barely oxygenate them."

The worst-hit hospitals talk of having been on the brink of not being able to cope. They describe nearly running out of specialized equipment and the skilled staff needed to monitor these highly unstable patients in their high-tech hospital beds.

Public health officials need to look for ways to keep novel H1N1 patients from getting this sick and help hospitals access enough key drugs, equipment and even staff to cope with an expected surge of cases in the fall and winter, says Dr. Anand Kumar, an intensive care physician who has treated dozens of these patients in Winnipeg.

Kumar was so concerned about what he saw in the city's ICUs earlier this year that he has been agitating, in medical and political circles, for stepped up pandemic preparations for the country's hospitals.

"I want the public health people to understand: If we breach ICU capacity, a lot of people are going to die," he cautions.

"What I've been telling everybody is: 'You've got to think about the ICU because the ICU, for these kinds of events, is your choke point."'

Kumar's warnings appear to have been heard. The Public Health Agency of Canada has convened a meeting this Wednesday and Thursday in Winnipeg designed to bring together critical care and public health experts to brainstorm on how to prepare for the next wave of illness.

The scientific director of the agency's National Microbiology Laboratory says one of the goals of the meeting is to try to figure out what leads to severe disease, in the hopes some such cases can be averted. But it's also about alerting intensive care specialists who haven't yet dealt with these types of cases about what to expect. What works. What doesn't. What problems might arise.

"My understanding from talking to the ICU docs across the country, but mainly in Winnipeg, is that there are some particular challenges with managing the people who have severe pneumonitis (inflammation of the lungs)," says Dr. Frank Plummer. "Understanding that and exchanging that information between intensive care doctors is important."

"It's not just about more ventilators, although that probably will be part of it. But I think it's about the actual techniques and technologies that were required to keep these people going. They needed really advanced respiratory support from my understanding."

That's not all they need. Kumar notes these patients [b]require high doses of sedating medications for long periods of time, so they don't struggle and actually fight against the ventilators being used to keep them alive.

During Winnipeg's outbreak the hospitals treating severely ill swine flu patients went through a year's supply of the sedating drugs in just two months, Kumar says.

"For some reason - and we don't know why yet - these patients are incredibly agitated and require incredibly high doses of sedation," he says, adding he's asked federal officials to alert manufacturers so they can step up production.

Winnipeg treated about 50 confirmed swine flu cases and another 15 who looked just like them but didn't test positive for the virus.

Kumar thinks the recommended test - a swab inserted deep into the nose - isn't reliable in severely ill patients. He thinks other specimens, from lower down in the respiratory tract, should be searched for viruses.

He's warned his ICU peers that patients who look like swine flu cases probably are swine flu cases and should be treated as such. "Look, guys, the test may say that it's negative, but think about it."

At a recent meeting of the U.S. Institute of Medicine exploring the question of what equipment health-care workers need to protect them during the pandemic, an intensive care specialist from Salt Lake City, Utah, warned two-thirds of his hospital's 60 or so ICU patients with swine flu developed acute respiratory distress syndrome or ARDS, a condition that is very difficult to treat.

These patients weren't old, said Dr. Russell Miller, medical director of respiratory ICU at Intermountain Medical Center. In fact, the median age was about 30 years old.

One day the hospital nearly ran out of the dialysis machines needed to do the work of failing kidneys. And it came close to having a shortage of ICU nurses. Miller suggested hospitals preparing for the fall and winter need to think about how they will allocate resources and the difficult issue of triaging care.

Kumar agrees that hospitals need to plan for how they'll cope if ICUs become over-burdened with pandemic flu cases, something that nearly happened in Winnipeg.

"Had the situation persisted much longer, we would have been looking to shift ... (non-H1N1) patients to other cities, basically, in order to concentrate on dealing with our own guys. And we would have had to formally cancel surgery."

Other things hospitals and local and provincial authorities need to think about is whether legal arrangements are in place that would allow for the shifting of resources - people and specialized medical equipment - across provincial and territorial boundaries, Hebert said in a recent editorial in the Canadian Medical Association Journal.

If Saskatchewan needed more ventilators and Alberta had spares, could they be transferred? How could Alberta be assured it could get the ventilators back when it needed them?

Kumar says ICU specialists are experts at thinking outside the box - finding something else to try when standard approaches fail.

That's a skill they'll need with these patients, he suggests, noting some places used extra-corporeal membrane oxygenators or ECMOs - devices like the heart-and-lung bypass machines normally used in heart operations - to oxygenate the patients until their lungs could recover.

He says planners need to look at expanding their supplies of a range of medicines and disposable medical equipment. And they need to be preparing for the fact that while flu works its way through a community, ICU staff may end up sleeping in the hospitals.

No one knows what this new flu virus has in store for humans. But health-care professionals who've dealt with the sickest pandemic flu patients say it makes sense to prepare for tough times.

"I always say that the one thing I don't want to do is in a year look back and say 'I could have done this' or 'I should have done that' kind of thing," Kumar says. "I'd rather look back and say: 'Man, I really over-reacted."'

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Canadians ambivalent about whether to get a pandemic flu shot, poll suggests
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...g0okxyeKzx9gMkg


TORONTO — Canadians aren't clamouring en masse for swine flu vaccine, a new poll suggests.

The Canadian Press Harris-Decima poll also indicates some parents have concerns about allowing their children to have a vaccine that contains an adjuvant, a compound that boosts the impact of the vaccine and allows smaller doses to be used.

Only about 45 per cent of respondents intend to get pandemic vaccine when the shots become available later in the fall, the poll found. An equal percentage said they would not take the pandemic shot.

"I think the data show that there is an ambivalence in Canadians about the vaccine," said Dr. Kumanan Wilson, a scientist at the Ottawa Health Research Institute who has done a lot of research on the anti-vaccination movement.

"I think that public health officials need to be concerned about that. Simply having the vaccine isn't going to be enough to have a successful program."

Dr. David Butler-Jones, Canada's chief public health officer, called the numbers "unfortunate" but admitted the agency has actually seen worse.

Butler-Jones said the public health agency has seen polls suggesting the percentage of people who might agree to be vaccinated against the pandemic virus could range from as low as the high 30s to about 60 per cent.

"It is disappointing but we'll see at the end of the day how many people do get immunized," he said, adding that the agency plans to launch a communications campaign aimed at arming people with science so they aren't making their decisions based on "rumours."

The findings are based on telephone interviews conducted between Aug. 20 and Aug. 23. Just over 1,000 Canadians were surveyed, giving the poll a margin of error of plus or minus 3.1 percentage points, 19 times out of 20.

The figure showing how many Canadians plan to get the pandemic vaccine is higher than for the seasonal flu shot. Last year, for instance, just under a third of Canadians were vaccinated against seasonal flu, according to Statistics Canada.

But it's below uptake rates projected by recent polls in the United States.

Last week an American Red Cross survey suggested as many as 60 per cent of Americans wanted to be vaccinated. A USA Today poll published Tuesday suggested 55 per cent of Americans plan to get a pandemic flu shot.

With seasonal flu vaccine, uptake is highest among seniors and lowest among healthy adults. And The Canadian Press Harris-Decima poll showed a similar breakdown when it came to the intentions of various age groups, with 56 per cent of adults 18-34 saying they don't intend to get the shot or shots. (The pandemic vaccine may require two doses to protect.)

But this flu virus seems to preferentially attack the young and spare older adults. The poll results suggest that if healthy adults are targeted for the Canadian vaccination programs, efforts are going to be needed to get them to come forward.

"I think it's going to be a tough sell," Wilson said of the vaccination program in general.

"And I don't think . . . they want to be particularly coercive about this. They're going to have to pick their battles. They're going to have to identify again what are their most important populations to target."

Modelling studies suggest that targeting children and the adults around them would reduce dramatically the spread of flu viruses.

But while 56 per cent of parents who were surveyed said they planned to get their children under 18 years old vaccinated, 30 per cent said they would not. And when the question turned to the use of boosting chemicals known as adjuvants, reluctance rose.

When respondents were asked if they'd allow their children to be vaccinated with vaccine containing an adjuvant, described as a compound that boosts the impact of the vaccine but which hasn't been licensed in previous flu vaccines in Canada, the percentage of parents willing to have their children vaccinated dropped to 35 per cent.

Canadian government officials have indicated they intend to use vaccine with adjuvant, as long as no safety concerns arise.

"If they can't get a good enough uptake among school-aged children that's going to undermine any vaccination program. Because that's the key population, I think," Wilson said.

Vaccine expert Dr. Scott Halperin said if the vaccination rates mirror the poll findings, the ability to limit spread of the virus will be lessened.

"Certainly if you have a larger proportion of people protected, you're going to have less spread of the infection," he said from Geneva, where he is attending a meeting.

Halperin, who is director of the Canadian Center for Vaccinology at Dalhousie University in Halifax, said he thinks the poll findings show that officials need to step up the messaging about the benefits of pandemic vaccine.

"This gives us a first blush of what people are planning to do," he said.

"I don't know if it's going to be more or less. But I still think it's a warning sign for public health that there is a lot of work that needs to be done."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Lung damage in fatal swine flu cases more bird flu than seasonal flu: expert
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...TOLww9vZDfTijgg


TORONTO — The lungs of people who have died from swine flu look more like those of the victims of H5N1 avian influenza than those of people who succumb to regular flu, the chief of infectious diseases pathology at the U.S. Centers for Disease Control says.

Study of about 70 fatal H1N1 cases so far also reveals there may be more incidences of co-infections with bacteria than was earlier thought, Dr. Sherif Zaki told The Canadian Press in an interview.

The damage to lung tissue is consistent with that inflicted by ARDS or acute respiratory distress symptom, Zaki says, referring to an often-fatal, difficult-to-treat syndrome that can have a number of causes. The U.S. National Heart, Lung and Blood Institute estimates about 30 per cent of people who develop ARDS die.

"In terms of the disease, yes, it (H1N1) is remarkably different than seasonal flu," Zaki says. "The pathology looks very similar to H5(N1)."

The dangerous avian flu virus has killed 60 per cent of the 440 people known to have been infected with it. To date, though, the virus hasn't acquired the capacity to spread easily from person to person.

The swine flu patients who went on to die suffered lung damage and changes in the lungs that would have made it difficult to deliver enough oxygen into their bloodstreams, Zaki says.

That reflects the observation of intensive care doctors who've struggled to save these profoundly ill patients.

"That's what they saw in Winnipeg," Dr. Paul Hebert, an intensive care physician and editor of the Canadian Medical Association Journal, said recently of how hard it is to oxygenate swine flu patients who become gravely ill.

"They have everybody on experimental ventilators and techniques. They can barely keep them alive."

A number of doctors who have treated novel H1N1 patients - and colleagues who haven't yet - were meeting in Winnipeg this week discussing what steps hospitals and ICUs need to take to get ready for an expected increase in pandemic flu cases this fall and winter.

Zaki says finding ways to prevent cases from progressing to severe illness should be the goal, "because once it happens in these patients . . . it's very difficult to treat."

Strikingly high levels of virus were spotted in the lungs of people who died rapidly from swine flu, he says, though less is seen in those who die after a longer battle with the virus.

"Some people die very quickly of it, within days. And some have more protracted illness, maybe two, three weeks," he says.

"It's surprising the amounts (of virus) that you see.... But it's not unheard of," he adds, pointing to what was seen with SARS.

Earlier studies conducted in tissue culture and in ferrets - the best animal model for human flu - found the new virus is drawn to tissue found deep in the lung. That's a penchant it shares with H5N1. Seasonal flu viruses attack the upper airways.

Zaki says about a third of the fatal cases his team has reviewed involved co-infection with a bacterium, though the culprit varies.

Sometimes it is Staphylococcus aureus - the drug-resistant kind, known by the nickname MRSA and antibiotic-sensitive varieties as well. Some cases have involved group A Streptococcus. And some have been co-infection with Streptococcus pneumoniae.

"Those are the main three that we found."

"It was not very clear initially," Zaki adds of the frequency with which co-infection seems to occur in these cases. "But the more we studied, the more we realized that these do happen."

He suggests pneumococcal vaccine, used in the elderly to lower the risk of pneumonia, could be a useful tool if given to younger people. The highest numbers of deaths so far have been in people in their late 30s and 40s.

Some of the cases of co-infection have been in people who were hospitalized for an extended period, which wouldn't be all that surprising. But some were seen in people who weren't hospitalized.

With the new virus causing severe disease in only a small portion of cases, public health authorities have been criticized for overreacting and overhyping the threat swine flu poses. Some critics have suggested the new flu isn't really much worse than seasonal influenza.

From Zaki's vantage point, however, this is not regular flu.

"This is a new virus. It causes a different disease than what we're used to," he says. "So I don't think anybody can predict exactly, but it would be foolish not to be trying to study the disease more."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Canada to buy unadjuvanted vaccine for pregnant women, health officer says
Friday, 04 September 2009
http://www.medicinehatnews.com/content/view/131936/


TORONTO - Canada will purchase supplies of unadjuvanted swine flu vaccine to offer to pregnant women who might otherwise choose not to be vaccinated, the country's chief public health officer has revealed.

Dr. David Butler-Jones told The Canadian Press that Canada will buy 1.2 million doses of unadjuvanted pandemic vaccine which will be reserved for pregnant women, who are at significantly greater risk of becoming severely ill and dying if they contract the virus.

"I'm anticipating for pregnant women we will have an option," he said in an interview.

The vaccine will be supplied by GlaxoSmithKline, Canada's pandemic vaccine manufacturer, and is expected to be available at the same time as the country's other supplies of vaccine.

Adjuvants are compounds that boost the immune system's response to vaccine, allowing smaller doses to be used per person. Canada is buying adjuvanted pandemic vaccine partly in response to a call from the World Health Organization for affluent countries to use "antigen (vaccine) sparing" techniques so that limited global supplies can be stretched as far as possible.

While some European countries have used adjuvanted flu vaccines for a number of years, none of the currently licensed flu vaccines in Canada contains an adjuvant.

And there are no data on the use of adjuvanted flu vaccine in pregnant women - a fact that may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy.

"What is absolutely clear is that there is much more of a safety data base in pregnant woman with non-adjuvanted vaccine," said Dr. Marie-Paule Kieny, head of the WHO's vaccine research initiative, the division overseeing pandemic vaccine issues.

"Does it mean that it (adjuvanted vaccine) will be unsafe? No. It means that there is no hard evidence that it will be (safe)."

The lack of evidence led a panel of experts that advises the WHO on vaccine issues to recommend unadjuvanted vaccine be offered to pregnant women if that option is available.

Butler-Jones said some pregnant women may prefer an adjuvanted formulation, because it's likely to protect more broadly against mutated strains of the virus if and when they arise, and because it can be taken in smaller doses.

Another plus, he said, is that one dose of adjuvanted vaccine might suffice, meaning pregnant women could be protected faster than if they had to get two doses of an unadjuvanted vaccine. (Dose requirements for swine flu vaccines are still being determined.)

But the decision to buy unadjuvanted vaccine for pregnant women - something the Public Health Agency of Canada had earlier said it would not do - reflects the very real fear of public health officials that pregnant women may shun this vaccine.

"I think that it is possible that a good chunk of the (pregnant) patients may just say: 'You know what? No thanks.' And that's obviously a problem," said Dr. Richard Beigi, an academic obstetrician from Pittsburgh who recently published results of a survey suggesting few pregnant women would agree to take a pandemic flu shot.

"I think it is going to be challenging," Kris Sheedy, head of the H1N1 vaccine communications team at the U.S. Centers for Disease Control, said of the effort to convince pregnant women they should get a pandemic flu shot.

It is well known that in previous pandemics pregnant women were the hardest hit group in terms of deaths. And this time around, there have been many reports already of miscarriages, emergency deliveries and deaths in pregnant women who caught swine flu.

Pregnant women are also at greater risk of complications from catching seasonal flu. Yet their willingness to be vaccinated against it remains low, despite government recommendations that they should get flu shots.

Sheedy said in the U.S., around 15 per cent of pregnant women get vaccinated most years. Dr. Jeff Kwong, a University of Toronto researcher who studies flu shot rates, said he doesn't know of a corresponding national figure for Canada. But a small study in Toronto during the 2003-04 flu season showed 14 per cent of women got a flu shot during their pregnancy.

Beigi's survey asked nearly 400 pregnant women if they would agree to be vaccinated with an avian influenza vaccine during a pandemic caused by that virus.

The survey was conducted before swine flu broke out and was done in the context of fears that the H5N1 virus - which kills roughly 60 per cent of the people who catch it - might cause the next pandemic.

Despite the high fatality rate of the H5 virus, only 15.4 per cent of the pregnant women surveyed said they'd take a shot if a bird flu pandemic erupted. And half the office staff of the obstetrical practices where the survey was conducted said they would not recommend the pregnant women in their care get pandemic vaccine.

"I was relatively shocked at the responses," said Beigi, who teaches in the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh Medical Center.

Sheedy said the CDC plans to work with obstetricians, hoping to persuade them to make the case for pandemic vaccination to their patients. Studies have shown, she said, that pregnant women value highly the advice they get from their obstetricians.

"I'm empathetic," she said, noting she has a two year old and a five year old, and remembers well the concerns of pregnancy.

"I understand that some (pregnant women) are going to choose not to vaccinate, but I do hope that if we're able to get information out there about what we're seeing with this virus and its impact on these women, that many of them will at least ... consider it."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

People at high risk from swine flu should talk with doctors now about flu drugs
By Helen Branswell Medical Reporter (CP) – 5 hours ago
http://www.google.com/hostednews/ca...n9AHbNDa1Ho54eQ


TORONTO — Pregnant women and people with chronic health conditions who are at higher risk of getting severely ill if they catch swine flu should talk with their doctors about setting up a way to get rapid access to antiviral drugs if they get sick, public health authorities are suggesting.

Officials of the Public Health Agency of Canada and the U.S. Centers for Disease Control say people who fall into high risk groups should explore the possibility of having a prescription for Tamiflu or Relenza issued in advance but held by the doctor.

If the person got sick with what seems like the pandemic virus, he or she could call the doctor, describe the symptoms and arrange to have the prescription transmitted to a pharmacy, filled and picked up, they said.

"We think it is important for these risk group patients to be counselled about the signs and symptoms to be watching for and providers to think through how they can really reach their patients quickly during a busy season in the months ahead," Dr. Anne Schuchat, director of the CDC's national center for immunization and respiratory diseases, said Tuesday.

"We do feel that prompt treatment is important and that the doctors' offices may get relatively busy and it may be reasonable in some circumstances for a phone conversation to be sufficient for a prescription to be filled."

Schuchat noted many of the people in the high risk groups already have regular contact with their doctors and could use the opportunity of a scheduled appointment to raise the issue.

Tamiflu (the brand name for oseltamivir) and Relenza (zanamivir) are neuraminidase inhibitors, drugs that lessen and shorten the impact of a bout of flu by blocking the virus's ability to replicate. For maximum effect they should be taken within 48 hours of the onset of symptoms, though doctors do give them to hospitalized flu patients outside of the 48-hour window.

Pregnant women are at higher risk of complications from any flu, and pandemic flu viruses particularly hit them very hard. Since the new H1N1 virus emerged in the spring there have been frequent reports of miscarriages, emergency deliveries and deaths in pregnant women who have become infected.

And a high proportion of people who become gravely ill with swine flu - as high as 90 per cent in some case studies - have chronic conditions or illnesses that elevate their risk. Extreme obesity, asthma, heart disease, chronic pulmonary obstructive disorder - these and other health conditions are disproportionately common in the sickest of pandemic flu patients.

The head of the Public Health Agency of Canada has also suggested doctors and high-risk patients lay the groundwork for rapid antiviral access.

"When you do have that regular visit, have a conversation about if I do get influenza-like symptoms, you know, fever, headache, muscle aches, cough, etc., what should I do?" Dr. David Butler-Jones said last week at a news conference.

"And consider maybe having a prescription for Tamiflu or whatever ready so that you don't have to book an appointment and maybe you just have to call the doctor's office and say I have these symptoms, etc."

"You don't need to rush into your doctor now but if you have a regular appointment it's an important question to ask."

That said, Butler-Jones said he doesn't support the idea of people filling prescriptions before they get sick and keeping the drugs at home. That would leave drugs in the hands of some people who won't get sick or won't need them, he said.

Schuchat, who was announcing changes to the CDC's recommendations on flu antiviral use, stressed that most people who catch this virus won't need antiviral drugs to recover.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Tamiflu-resistant swine flu viruses may have spread in U.S. summer camp
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...-uUE5fLl5N_-GKA


Two American campers developed Tamiflu-resistant swine flu earlier this summer, the best evidence to date that resistant pandemic viruses may have passed from one person to another, the U.S. Centers for Disease Control reported Thursday.

Viruses from both campers contained a mutation that hasn't been seen before with the pandemic virus, a finding that heightens suspicions that drug resistant virus was either transmitted from one child to the other or that both were infected by someone else who wasn't turned up in the investigation.

The previously identified cases of Tamiflu-resistant swine flu viruses have been isolated - people who took the drug, either for prevention or treatment. There was one exception: a girl from San Francisco who hadn't taken the drug and therefore must have caught a resistant virus from someone else. The source was never identified.

"These are a bit different in that they were linked to each other, which suggests that resistant virus was likely either transmitted to both of them from somebody else or transmitted from one to the other," Dr. Zach Moore, a respiratory disease epidemiologist with the North Carolina division of public health in Raleigh, said of the campers.

Moore was one of the authors of the study, which was published Thursday in Morbidity and Mortality Weekly Report, the CDC's weekly fast-track public health journal.

Moore said there is also a possibility that resistance developed independently in both of these campers. But the presence of the new mutation in viruses found in both girls makes that option seem less likely, said Dr. Frederick Hayden, a leading antiviral expert at the University of Virginia.

"It does serve as another ... marker to suggest that the virus that the two girls had might be the same one," Hayden said when asked to comment on the report. He was not involved in the investigation.

The CDC said the function of the new mutation, at position 223, isn't yet known.

But Hayden said a similar mutation has been reported in the H3N2 seasonal flu virus. In H3N2, the 223 mutation isn't enough to trigger resistance on its own. But when found in combination with another mutation - which the North Carolina viruses had - it further reduces response to the drug.

The report brings to 21 the number of known cases of novel H1N1 resistance to oseltamivir or Tamiflu, said Charles Penn, an antiviral expert with the World Health Organization. Those cases have occurred in Denmark, Japan, China (on the mainland and in Hong Kong), Canada, the United States and Singapore.

Penn said all those viruses were sensitive to zanamivir or Relenza, a drug in the same class as Tamiflu.

The camp outbreak occurred in July and it appears that if there was spread of resistant viruses there, the chain of transmission was subsequently broken.

"There's no evidence that this has become widespread," Moore said, noting his department sent a larger than normal number of viruses to the CDC for drug susceptibility testing after the outbreak to see if there might be spread elsewhere in the state.

Of 59 viruses checked, none carried the mutation known to render these viruses resistant to Tamiflu. And none carried the additional mutation seen in the viruses from the campers.

The adolescent girls shared a cabin and both developed swine flu despite being given the drug on a preventative basis. The camp they were attending was experiencing a large swine flu outbreak and over 400 campers and nearly 200 staff members were given Tamiflu or Relenza to try to prevent infection.

An editorial commentary following the article noted these cases underscore the importance of not giving healthy people oseltamivir - sold as Tamiflu - to prevent infection after they've been exposed to the pandemic virus. Using the drug to prevent infection is called prophylaxis

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Swine flu vaccination should be much easier than expected - 1 dose should do
Friday, 11 September
By Helen Branswell
Medical Reporter THE CANADIAN PRESS
http://fftimes.com/node/227310


TORONTO — Mass vaccination programs against swine flu are going to be a lot easier to mount than first thought, experts said Thursday after the fast-tracked publication of studies showing one dose should be enough to protect most adults.

Two vaccine makers, CSL of Australia and Novartis Vaccines and Biologics of Cambridge, Ma., reported that a single dose of vaccine induced a protective response in a high proportion of adults tested.

CSL saw the robust response with one dose of 15 micrograms — the amount per strain in a seasonal flu shot — of plain vaccine. Novartis was testing half- and standard-sized doses of vaccine with a boosting additive known as an adjuvant.

The findings will be backed by results of trials in adults and seniors to be released Friday by the U.S. National Institutes of Health, said Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases.
“The data from the NIH clinical trial on unadjuvanted H1N1 pandemic vaccine verifies and corroborates the exciting data that have come out on the unadjuvanted vaccine in the New England Journal of Medicine,” Fauci said in an interview from Bethesda, Md.

Fauci noted the NIH research saw a similarly strong response within eight to 10 days of a single dose, which is very quick by vaccine terms. Studies have shown it can take four weeks or longer for a person to develop a strong response when vaccinated against a new pathogen.
The findings suggest the limited global supplies of pandemic vaccine can be stretched to cover double the number of people who could have been vaccinated if two doses were needed. And public health officials would heave sighs of relief at the prospect of not having to round up people to get two shots of pandemic flu vaccine and a shot of seasonal flu vaccine this fall.

“It’s going to end up being a much simpler campaign,” said Dr. John Treanor, an vaccine expert at the University of Rochester in northwestern New York state.

“This is all very, very promising,” agreed Dr. David Butler-Jones, Canada’s chief medical officer of health. He cautioned, though, that it remains to be seen if one shot will work for teens and children, seniors and people with compromised immune systems.

The Public Health Agency of Canada is buying vaccine with adjuvant from vaccine giant GlaxoSmithKline, which has yet to release findings of its clinical trials. A clinical trial that will be used to license the GSK vaccine made for Canada will begin next week, Butler-Jones said.
CSL reported that nearly 98 per cent of volunteers who got one shot of 15 micrograms of vaccine mounted an antibody response which should be protective. And Novartis said that 76 per cent and 92 per cent of volunteers crossed the protective threshold, depending on the test used to measure the response.

In both trials a fair proportion of recipients reported side-effects, but of the type seen with seasonal flu shots — mainly discomfort at the site of the injection.
Treanor and Fauci said the results suggest people’s immune systems respond to this vaccine the way they do to seasonal H1N1 flu vaccine.

Even though studies suggest most people under 60 don’t generate antibodies to this new H1N1 virus, earlier exposures to H1N1 viruses or vaccines must have “primed” immune systems, they said. The single-dose response suggests the vaccine is working like a booster shot, reawakening the immune system to a threat similar to something it confronted in the past.

“This is an immunogenic vaccine that you’re already primed to respond to and will, I’m sure, behave exactly the same way that any seasonal flu vaccine would behave in terms of its ability to induce antibody,” Treanor said.
“If you jump on that wagon and say that ‘Well, this is going to be like any other H1 flu vaccine’ your conclusion would be that probably kids over nine years of age or so, you’re going to be able to vaccinate with a single dose. But you don’t know that for sure.”

Children under nine could be a different matter, because they’ve had so much less exposure to flu viruses and vaccines. Even with seasonal flu vaccine two doses are recommended for children younger than nine who’ve never been vaccinated before. That may be what’s needed with this vaccine as well.

Fauci, a renown immunologist, said the strong adult response suggests there’s something in the immune system that isn’t being measured when laboratories look for antibodies to this new virus.

Despite the promising results, however, the fact remains that swine flu viruses have a big jump on swine flu vaccine availability in North America. Transmission never really died off in the summer and outbreaks are starting to take off again in places where schools and universities have been in session for several weeks.

“The problem is, the virus isn’t co-operating,” said Dr. Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.

“And given what we’re seeing with transmission in North America, it’s very likely that by the time the first drop of vaccine is in an arm, we could be on the downside of this wave.”

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Low levels of key antibodies may lead to severe disease, study suggests
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...Alyuj48dD91QwKA


TORONTO — Australian researchers may have uncovered a clue as to why some people who catch swine flu suffer life-threatening illness. And if they are right, there is an existing weapon in the treatment arsenal that could help reduce the pandemic death toll.

The group found that pregnant women who became severely ill with the new H1N1 virus had low levels of a particular antibody that is known to fight off viruses and help the body respond to vaccine. Moderately ill women were much less likely to have significantly suppressed levels of the antibody, the researchers reported.

"We all believe we may have stumbled onto something very interesting," said Dr. Lindsay Grayson, director of infectious disease at Austin Health, a network of three hospitals in Melbourne.

"To our knowledge it's the first time that a correlation or an association is being noted between severe influenza of any sort and a subtle but potentially important immune deficiency."

The team made the discovery when Grayson ordered a test that looked at antibody levels - not just by class, but looking at individual subtypes within those classes. The call was made in the case of a very sick patient whose decline was particularly rapid, and the team was debating whether immune globulin - a blood product containing antibodies harvested from donated blood - might help.

The testing showed the patient had low levels of an antibody called IgG2, which Grayson admitted came as a surprise. They started ordering tests on all their swine flu patients in ICU.

"What we found was almost everyone, all the patients who needed ICU were IgG2 deficient," he said in an interview from San Francisco, where the data were presented at ICAAC, the annual meeting of the American Society for Microbiology.

Severe cases had IgG2 levels that were about one-third of those detected in people who were moderately ill.

While the work was only done in pregnant women, Grayson and others said it would be useful to look to see if this deficiency might explain why a small subset of swine flu cases become gravely ill while most people only suffer through a bout of the flu. It's known that between two and 20 per cent of people have some antibody deficiency, he said, though not all of those people would be IgG2 deficient.

Three of four critically ill patients treated with immune globulin survived, defying predictions of those caring for them.

Dr. Donald Low, chief microbiologist at Toronto's Mount Sinai, said the findings are exciting, if preliminary, and might explain why aboriginals seem to be at greater risk of developing severe disease if they contract swine flu.

He suggested the hypothesis should be studied further. "It would be a fishing expedition, but obviously worthwhile."

"I think the bottom line is that this is obviously something that has to be looked into. And it may have therapeutic implication. ... It could be a marker for women at higher risk if they get infected to get more severe disease."

But Dr. Anand Kumar, an intensive care specialist from Winnipeg who treated a lot of severely ill swine flu patients in the spring and early summer, was not as optimistic.

"The results are just what I'd expect in any group of critically ill," he said by email.

Kumar, who is also an infectious diseases specialist, said it is not uncommon for all antibody levels to drop with critical illness and the more severe the sickness, the steeper the drop.

But he does think the notion of treating pandemic flu patients with antibodies harvested from other people makes sense, though he believes the immune globulin should be from people who've recovered from swine flu and have antibodies specific to the virus.

Grayson admitted they can't say at this point whether there is a cause-and-effect relationship at work here, meaning low IgG2 levels in the patients predisposed them to suffering from more severe disease once they caught the virus. But he doesn't believe the reverse is at play, that the infection caused the low IgG2 levels.

"We don't think that influenza is causing this deficiency. We think that instead the influenza is picking out those people who have the deficiency," he said.

The numbers are admittedly small and will require further study, likely in the Northern Hemisphere. Swine flu rates are dropping in Melbourne, Grayson said. Still, 16 of 19 severely ill patients had very low IgG2 levels, compared to three of 20 with moderate illness.

The team looked at healthy pregnant women and found that about 60 per cent of them were mildly deficient in IgG2 levels, which leads them to believe this may be one of the immune system changes that occurs to allow a pregnant woman to carry a foreign body - a fetus - without rejecting it. But Grayson said the group needs to follow women after they deliver to see if their IgG2 levels rise to normal levels.

Grayson said while the group's work hasn't proven their hypothesis, Northern Hemisphere doctors caring for the sickest of swine flu patients in the weeks and months to come should consider checking IgG2 levels and using immune globulin, which is often given to people seriously ill with some bacterial infections.

"In many ways, this is applying a general principle that we apply to bacteria diseases to now say well, 'Gee, we've made this interesting observation. This might work for influenza,"' he said.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Lack of thimerosal-free pandemic vaccine option leads some planning to pass
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...keqg37NttTxij2A


TORONTO — Canada will not be purchasing any thimerosal-free pandemic vaccine - a decision that concerns some pregnant women and young mothers and worries some officials who want to see pregnant women and young children vaccinated.

"You have to weigh the risks and you have to go with your comfort level. And I have a real problem with getting something that has a known neurotoxin in it," says a Toronto woman who declined to be identified because she's newly pregnant and hasn't told extended family and friends.

The pregnancy is factoring into her reluctance to be vaccinated against the pandemic flu virus. And she is concerned about using a vaccine containing thimerosal on her 21-month-old son.

"If it were just me, I get the flu shot every year and I know it has thimerosal in it. I kind of figure at this point I'm fully developed," the 32-year-old university graduate says.

"But for my young son and for a fetus? There's just too many unanswered questions."

Thimerosal is a preservative used to prevent contamination in multi-dose vials of vaccine. Though it's an organic mercury compound, experts believe it is safe. It's been used for years in vaccines.

But the burgeoning anti-vaccination movement has focused on it as a potential source of the harms they believe some children suffer due to vaccination. Multiple high calibre studies have not supported the claim, but opposition to thimerosal persists in some quarters.

The Toronto woman says mommy blogs and boards on the Internet are ablaze with debate about whether pandemic vaccine with thimerosal is safe for young children and moms-to-be.

Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion, is convinced it is.

"Personally, no, I'm not concerned about that," says Gardam. "(But) I'm not the pregnant woman getting the injection who's reading stuff about thimerosal and autism and God knows what else."

He admits he is worried that some people who should be in line for pandemic vaccine won't come forward because of the lack of a thimerosal-free option.

On Wednesday, the Public Health Agency of Canada released its recommendations for who should be first in line for pandemic flu vaccine. Pregnant women, who are at an elevated risk of severe disease or death if infected with this virus, and children between six months and five years were on the list. (Flu shots aren't given to infants under six months of age.)

"I have concerns that people won't get it because thimerosal is there," Gardam says. "People's concerns are their concerns."

The Public Health Agency of Canada refused a request for an interview on the issue. Instead, a media relations adviser emailed material stressing that thimerosal actually adds to the safety of vaccine by preventing contamination that can result in bloodstream infections and abscesses.

"There is no safety reason to avoid thimerosal-containing vaccines," the email says.

It goes on to state that a panel of experts that advises the federal, provincial and territorial governments on vaccine issues, the National Advisory Committee on Immunization, has thoroughly reviewed the evidence and indicated there is "no legitimate safety reason to avoid the use of thimerosal-containing products for children or older individuals, including pregnant women."

That position is also held by the World Health Organization, the U.S. Food and Drug Administration and the Institute of Medicine, a forum of experts that advises the U.S. government, the email notes.

But the email doesn't make note of the fact that the National Advisory Committee on Immunization has also endorsed a long-term goal of removing thimerosal from vaccines, when safe and effective alternatives are available.

The pregnant Toronto woman knows that, however. She has read up on the issue and she cites NACI's position as she explains her reluctance to be vaccinated while pregnant.

She also knows the U.S. government has ordered supplies of thimerosal-free pandemic vaccine for use in pregnant women and young children. If the U.S. can do it, why can't Canada, she asks? "That doesn't seem unreasonable to me."

The answer may relate to the fact that the United States has contracts with multiple suppliers of vaccine - five, to be precise. Some of them sell single-dose pre-loaded syringes of flu vaccine without thimerosal.

Canada, on the other hand, has a contract with a single vaccine manufacturer, GlaxoSmithKline, for vaccine made at a plant at Ste-Foy, Que. It cannot currently offer thimerosal-free vaccine.

"While thimerosal-free formulation are under currently under development, all commercial vaccines currently produced by Ste-Foy are thimerosal-containing," GSK spokesperson Marie-Christine Beauchemin says in an email.

"Its content is within the limits allowed by health authorities."

Public health expert Dr. Kumanan Wilson, of the Ottawa Hospital Research Institute, says the American decision to offer some pandemic vaccine without thimerosal may be due to the greater profile the anti-vaccination movement has there.

"They're much more sensitized to the anti-vaccine movement. And thimerosal's such a big issue in the U.S."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Discussion of vaccine with new adjuvant that will be used in Canada.

Feds right to dot I's, cross the T's on pandemic vaccine approval: Doctors
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...LjeSUvnZSpdrJQA


TORONTO — A choir of voices is calling for Canada to speed up the start of its pandemic flu vaccination program. Interestingly, though, some of the country's leading public health and infectious diseases experts aren't singing the same tune.

A number of them say the benefits that might be gained from releasing pandemic vaccine under emergency use provisions may not be worth the risk of sowing distrust of the vaccine among members of the public.

"This is a real tightrope walk," says Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion.

"Because given it's a new virus vaccine, given it's an adjuvant we haven't used before, given the disease is relatively mild, I want to feel confident that when we roll out the vaccine that the checks and balances are in place and that we've got decent safety data and decent efficacy data before it goes out."

"And that is why in my mind... I have come down on the side of 'Let's by all means get this out and let's offer this to people. And let's make sure we've crossed our T's and dotted our I's before we do it."'

Dr. Donald Low, a leading figure in Canada's response to the 2003 SARS crisis, shares that view. He points to the high degree of public awareness of the 1976 swine flu affair.

That event, which casts a long shadow over the response to this pandemic, saw more than 40 million Americans vaccinated against a pandemic that never materialize. For reasons that still aren't understood, the vaccine seemed to trigger 500 cases of the paralytic condition Guillain-Barre syndrome and about 25 deaths.

Experts expect this vaccine to be as safe as seasonal flu vaccine. But they know that if problems were to arise, particularly in a vaccine the public perceived to have been sped through licensure, that would have enormous consequences - and not just for future flu shot campaigns. The burgeoning anti-vaccination movement has swine flu vaccine in the cross-hairs.

"I think that you want to make sure that you're doing this right. And to rush things and take short cuts and make a mistake, the damage would last for a long, long time," says Low, chief of microbiology at Toronto's Mount Sinai Hospital.

"They have to really be cautious," he says of the federal government. "You can't sort of just rush it without a lot of thought."

Low notes Canada has alternatives in its pandemic flu arsenal - millions of stockpiled treatment courses of Tamiflu and Relenza, another antiviral drug. "You've got something to fall back on here. It's not like you don't have anything."

Despite internationally acknowledged foresight, years of planning and tons of hard work on the part of officials of both Health Canada (the regulatory arm) and the Public Health Agency of Canada, this country seems poised to start vaccinating against the swine flu virus weeks after the Americans, the Chinese and some European countries.

China has already started to immunize. Australia will begin on Sept. 30. In the U.S., officials said Friday they will send out 3.4 million doses of vaccine to states at the beginning of October; by mid next month, 20 million doses a week will be in the distribution pipeline.

As things stand, the first Canadians will be vaccinated in mid-November. Dr. David Butler-Jones, head of the Public Health Agency of Canada, has said that date could conceivably be pushed up a little, if the risks from the virus seemed to be outweighing the benefits of giving the vaccine full approval.

With flu activity in the United States already gaining steam, many experts south of the border have warned even the U.S. effort might be too late to have a real impact on the second wave of the pandemic in that country.

The immune system needs at least eight to 10 days to work up protective levels of antibodies after novel H1N1 vaccine is given. And a wave of flu activity in a given community lasts about seven weeks, but peaks about Week 4.

Though influenza is mercurial and defies prediction, if the U.S. is gripped by widespread flu activity a couple of weeks from now it's hard to imagine at least parts of Canada won't be as well.

Canadians authorities are under pressure to speed up release of the vaccine. In the House of Commons on Friday, opposition MPs hammered the government for moving too slowly. And the Canadian Medical Association Journal has called for expedited access to vaccine for people at high risk of complications or death from the flu, such as pregnant women.

The journal's editor, Dr. Paul Hebert, is an intensive care doctor who has treated gravely ill swine flu patients. He admits that experience is influencing his position on further fast-tracking the pandemic vaccine.

But experts from other parts of the medical community look at things differently as they try to find the sweet spot between speed, vaccine safety and public acceptance.

"The people who are charged with making a decision about whether there's going to be emergency release or not will have to make a judgment call about whether the potential risks of an interim authorization order, the emergency release, are worth it given where the pandemic is in different parts of the country when it happens," says Dr. Allison McGeer, an influenza expert and head of infection control at Mount Sinai Hospital.

Generally speaking public health and infectious diseases experts are keen proponents of flu shots. But they also know that this virus isn't mowing people down left, right and centre. If it were, there'd be no discussion of crossing T's and dotting I's.

"At the moment we're agonizing about a situation in which in fact the risks are not enormous," McGeer says. "This is a good pandemic as pandemics go."

A public health researcher who has done a lot of work on the anti-vaccination movement says that's probably factoring heavily into the federal decision making.

"We don't know how bad this thing's going to be and it may not be very bad at all," says Dr. Kumanan Wilson of the Ottawa Hospital Research Institute.

"And do you want to aggressively accelerate the safety assessment of the vaccine to get it out in time for something that may not be a big deal? So I think what they're doing is they're doing a 'wait and see,' he says of federal officials. "And if it does look like something more significant than perhaps what we might otherwise have anticipated is going to happen, they could accelerate that.""

"What they don't want do, I think, is push this vaccine aggressively, release it too early, have adverse events and find out that there really wasn't that big a deal. Because that will undermine all subsequent campaigns."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Canada vague on why it isn't donating H1N1 vaccine
Updated Mon. Sep. 21 2009 8:28 AM ET
Helen Branswell, The Canadian Press
http://www.ctv.ca/servlet/ArticleNe...0921?hub=Health


Canadian officials are being vague about why this country is conspicuously absent from a list of developed nations donating one-tenth of their pandemic vaccine to countries that don't have access to the shots.

The nine-country initiative, announced Thursday by U.S. President Barack Obama, involves the U.S., Britain, Australia, New Zealand, France, Italy, Switzerland, Brazil and Norway.

"At this time, Canada is doing an analysis of various options to support the provision of H1N1 vaccine to developing countries," the Public Health Agency of Canada said Friday in an emailed response to questions about why it hasn't joined the initiative.

The decision by the nine countries, some of the largest users of flu vaccine globally, was hailed by the World Health Organization as a commitment "to fairness in the sharing of a scarce resource."

The nine have said they will donate 10 per cent on an ongoing basis as vaccine becomes available.

"Given that current demand outstrips supply, these donations, together with the doses pledged by manufacturers, will help increase supplies of pandemic vaccines to populations that would otherwise not have access," the WHO said in a statement posted on its website.

Countries that want donated vaccine will have to assume all liability and release donor countries, manufacturers and the WHO from any claims in the event that adverse events are linked to use of the vaccine, the WHO says.

"This is not negotiable with the industry," Dr. Marie-Paule Kieny, head of the WHO's vaccine research initiative, explained in an interview with The Canadian Press.

Kieny said WHO regional offices will stipulate that condition to would-be recipients when they discuss the issue of vaccine access with countries that want to draw from the donated supplies.

It is currently unclear how much vaccine will be donated through the program with the nine countries, WHO spokesperson Gregory Hartl said Friday from Geneva.

But whatever the figure is, it will be in addition to donations totalling 150 million doses pledged by Sanofi Pasteur (100 million doses) and GlaxoSmithKline (50 million doses), Hartl said.

Canada has ordered 50.4 million doses of pandemic vaccine from GSK, which is making the product at its facility in Ste-Foy, Que. The order was placed when it was thought people might need two doses apiece to be protected against the new H1N1 virus. A number of recently published studies have revealed one shot should protect most adolescents, teens and adults.

Polls have suggested fewer than half of Canadians plan to get vaccinated against the pandemic virus, which causes mild disease in the vast majority of cases.

The lower-than-expected dosage need plus the potential soft demand means Canada may have many millions of unclaimed doses of vaccine, experts believe.

"I think we'll have lots of vaccine. I don't think it will be like the iPhone," said Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion.

Asked about the potential for surplus and whether Canada planned to donate all or some of the excess, the head of the Public Health Agency said if Canada's needs are not as great as it first thought, GSK can begin filling other country's orders sooner.

"We, as other countries, are obviously working with the WHO to look at the issue of needs and what the appropriate response would be," Dr. David Butler-Jones said Wednesday. "But no decisions have been made about that yet."

In its email on Friday, the agency noted that Canada has contributed over $100 million since 2003 to global pandemic preparedness and response, including technical assistance and financial donations to international organizations such as the United Nations and the WHO.

The WHO noted Friday that there will be "substantially less" pandemic vaccine worldwide than the previously forecast 94 million doses a week. Hartl said that means the amount produced in a year will fall short of the 4.9 billion doses WHO had hoped could be available for the pandemic.

A combination of factors contribute to the lowered output projection, including the fact that manufacturers have reported vaccine yield from the virus is substantially lower than that seen with seasonal flu production.

On the plus side, however, the dosing needs are lower. And it is unclear what international demand will be, given the generally mild nature of the infection the virus causes.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

I wonder if the Canadians are using the US and other countries that are vaccinating as soon as possible as a testing ground to make sure the vaccines are indeed safe. They probably think there is little to lose if they believe that "the U.S. {vaccination} effort might be too late to have a real impact on the second wave of the pandemic in that country"

__________________ 
.
.

Roscoe and Miss Priss 

One shot? Two shots? Experts deliberate on where to go with flu shots
September, 21, 2009 - 06:56 pm Reporter, Helen Branswell, Medical - (THE CANADIAN PRESS)
http://www.news1130.com/news/nation...tent=n203302124


TORONTO - One shot? Two shots? What to do with flu shots?

That may sound like a bad riff on a Dr. Seuss story, but it is actually the dilemma facing flu vaccine experts meeting this week in Melbourne, Australia.

Scientists from laboratories that form the World Health Organization's influenza collaborating centres network have gathered, as they do twice a year, to pore over global virus circulation patterns and reports of how similar or distinct - from an immune system point of view - new strains are compared to their recent ancestors.

The goal: To advise vaccine manufacturers and countries that buy seasonal flu vaccine which viruses are likely to be most problematic in the coming flu season, so vaccines can be tailored to protect against them. This meeting, the results of which are expected to be announced later this week, is tasked with selecting the strains for next winter's flu shots for the Southern Hemisphere.

But this isn't just another strain selection meeting. Flu is in a state of flux and it's not at all clear what kind of vaccine the Southern Hemisphere will need.

More pandemic vaccine to protect against the new H1N1 virus? Seasonal vaccine to protect against three families of viruses that have been making the rounds for decades, even though one or two of them may have stopped circulating by the time the vaccine is made? Or a new seasonal vaccine including the pandemic virus, either in addition to or instead of one of the seasonal strains?

"I don't envy them having to make some of these decisions," says Dr. Walter Dowdle, who headed the flu lab at the U.S. Centers for Disease Control during the last pandemic, the 1968 Hong Kong flu.

"It's going to be a bit more challenging this year than normal years," agrees Dr. Nancy Cox, who now heads the CDC's influenza division.

It takes months to make, distribute and administer flu vaccine, which is why experts are meeting in late September to decide on vaccine that will be injected into arms next June.

Because the picture of what's going to happen with the interplay of pandemic and seasonal flu viruses still hasn't come into focus, the WHO has told the experts to just select the strains and leave decisions on formulations of vaccine to another WHO advisory group, which will meet in late October.

The hope is by then flu's future path will be clearer. But Dowdle thinks the world may have to wait until the coming Northern Hemisphere flu season is done before it learns whether the pandemic virus is going to push the seasonal influenza A viruses out of the playground or share the turf with one or both of them.

In previous pandemics for which the causative virus is known - a very short list - the emergence of a new flu virus led to the obliteration of the influenza A virus that preceded it. The H1N1 virus that caused the 1918 pandemic disappeared when H2N2 materialized in 1957, triggering the Asian flu pandemic. When H3N2 appeared in 1968, H2N2 viruses stopped circulating.

But this time there's a twist.

In 1977, H1N1 viruses similar to those that had circulated before the 1957 pandemic reappeared. It's believed the re-emergence was the result of a lab accident in Russia. Whatever the source, those H1N1s managed to reseed themselves though they didn't cause a pandemic because there was so much immunity to H1N1 viruses in people over about age 30.

Ever since, two influenza A viruses - H3N2 and seasonal H1N1 - have co-existed in humans.

Since the swine flu H1N1 virus erupted late last winter, seasonal influenza A viruses have been few and far between. But they're not yet gone. In North America, pandemic viruses make up more than 96 per cent of circulating flu viruses. But will seasonal viruses make a comeback in what is our traditional flu season? Science doesn't currently have the tools to answer that question.

"We know a lot, but we don't know quite enough," says Dr. Marie-Paule Kieny, who heads the WHO's vaccine research initiative.

She suggests a number of options will be hashed out in the coming weeks and months, including keeping the pandemic vaccine separate and putting a pandemic component into the seasonal shot.

The latter could lead to the recommendation to make a flu vaccine that covers four strains - an idea that makes experts and industry alike groan. Or three, with the pandemic H1N1 replacing the seasonal H1N1, perhaps. Or in the best case scenario, if it seems both influenza As have been replaced, the recommendation could be to make a bivalent (two component) vaccine that protects against the pandemic strain and one influenza B virus.

"There are a number of options and each option has an impact on our production capacity," says Pascal Barollier, a spokesperson for Sanofi Pasteur, the world's largest flu vaccine producer.

"So we are compiling the options, looking at the impact on production capacities. And that will be part of the discussion and the recommendation that we might have, if we are asked to give an opinion as one of the manufacturers. But to date it's too early for us to comment on what would be the ideal solution."

Figuring out what would be ideal won't be easy. Ask several experts and you'll get several answers.

Dr. Scott Halperin, a vaccinologist at Dalhousie University in Halifax, thinks the pandemic vaccine should remain separate while the pandemic virus is mainly sparing the elderly. (It's believed that as the virus changes to be able to find new people to infect, it will broaden its scope.) It's too soon to incorporate it into the seasonal shot, he says.

"To me, you certainly don't want to do that the first year, you probably might not even want to do that the second year."

But Dr. Kathy Neuzil, who directs the influenza vaccine program at PATH, a global health non-profit organization based in Seattle, says having to organize two separate flu shot campaigns is not something public health should be saddled with for long.

Dowdle agrees. "You don't want to be stuck with two vaccines. The quicker you can get it into a combined formulation, the better off you are as far as administering the vaccine."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Concern about early surge of swine flu puts vaccine timing issues on the table
September 22, 2009 |
Helen Branswell, Medical Reporter, THE CANADIAN PRESS
http://www.thefreepress.ca/article/...&template=cpArt


TORONTO - In the face of concerns that swine flu may mount a fall surge, public health officials in Canada are rethinking pandemic and seasonal flu vaccination plans, with issues of timing and vaccine formulation back on the table, a variety of on-and off-the-record sources say.

The pros and cons of a number of scenarios are being hashed out, including delaying, cutting back or cancelling the seasonal flu shot effort and maybe even rethinking the decision to use an adjuvant in the formulation of the pandemic vaccine.

The hope is to get a consensus, so that provinces and territories use the same strategy, officials in Quebec and Ontario have said.

"We're trying to get a pan-Canadian approach here," said David Jansen, a spokesperson for the Ministry of Health and Long-Term Care in Ontario.

While the details are being worked out, Quebec says it will not start rolling out its seasonal flu shot program.

"For the moment, it's on hold," said Karine White, a media relations liaison with the Ministry of Health and Social Services in Quebec.

Up till now the plan has been for provinces and territories to run their seasonal flu shot programs first, starting essentially any time now. They would be followed up with pandemic vaccination efforts after swine flu vaccine is licensed for use in early-to-mid November.

Those plans anticipated that the pandemic virus might follow the pattern of seasonal flu, with a second wave hitting in the winter. But swine flu activity is already picking up in the United States and parts of Canada, including British Columbia, are seeing an uptick of cases.

The fear is that the wave may crest before pandemic vaccine is ready, or at least that vaccine will arrive too late to make a difference. Meanwhile, it's not clear whether seasonal influenza A viruses will reappear this winter and if they do how much disease they will cause.

"It doesn't make sense to be putting a lot of effort into delivering seasonal vaccine when the threat is something else that it's not going to protect against," said Dr. David Scheifele, director of the vaccine evaluation centre at B.C. Children's Hospital in Vancouver.

In previous pandemics, the new influenza A virus has replaced the influenza A virus that preceded it. While World Health Organization laboratories report they aren't finding many seasonal flu viruses, it's too soon to say if replacement of both the seasonal influenza A viruses will occur this time around.

And one can never predict how big a role influenza B viruses - which aren't vulnerable to the replacement phenomenon - will play in any given flu season.

White said Quebec is looking at a range of options. The seasonal vaccine could be given as usual or delayed until after the pandemic vaccination effort has been completed. Or a more limited seasonal shot campaign might be undertaken, one that would target people like seniors who would be at highest risk if seasonal flu viruses do circulate.

Another option she mentioned is cancelling seasonal flu shots altogether.

"All of these scenarios are on the table," White said from Quebec City.

But Scheifele and others believe it is premature to decide to junk the seasonal campaign, though the idea of a delayed and more targeted delivery of seasonal flu shots makes sense to some experts.

"We're not anticipating that the seasonal viruses will be circulating while the pandemic is unfolding. It pretty well crowds out the other viruses," Scheifele said.

"The concern is if the pandemic wave is over by Christmas, then there's still a lot of cold winter left for the other seasonal agents to return. If that's the case, then one could revisit the distribution of seasonal vaccines or simply pick up that thread in January."

Dr. Michael Gardam of the Ontario Agency for Health Protection and Promotion agrees it's an idea that is worth exploring.

"Looking at what's happened in the south (Southern Hemisphere) versus what we're having now versus the tendency of pandemic viruses to replace seasonal strains, it is very reasonable to have that discussion," said Gardam, the agency's director of infectious diseases prevention and control.

Another issue that appears to be on the table is the proposed use of an adjuvant in the pandemic vaccine. Adjuvants are additives that boost the impact of a vaccine, allowing a smaller dose to be used for each person.

Canada has said it will buy adjuvanted vaccine from GlaxoSmithKline, which has the country's pandemic vaccine production contract. GSK is making the vaccine at its facility in Ste-Foy, Que.

GSK plans to sell the vaccine in 3.75 microgram doses with adjuvant, a quarter of the size of the non-adjuvanted doses the United States will get from its pandemic vaccine suppliers.

While adjuvants have been used for years in Europe in flu vaccine targeted at seniors, there is currently no licensed flu vaccine containing adjuvant in this country. There is also no safety data for the use of adjuvanted vaccine in pregnant women, and little data on the safety of the additives in vaccines given to children.

Though it had first said it would only buy adjuvanted vaccine, the Public Health Agency of Canada has already shifted positions, announcing recently that it would buy 1.2 million doses of unadjuvanted pandemic vaccine to offer to pregnant women.

And agency head Dr. David Butler-Jones has hinted there may be room for further movement, a response to concerns from some experts that parents may decide not to vaccinate their children if the vaccine contains an adjuvant.

"I think David Butler-Jones et al. are thinking about making the non-adjuvanted vaccine a little more widely available," said Scheifele, who believes adjuvanted vaccines will be an improvement on the existing models, but says he would like some safety data on their use in children before embarking on widespread use.

Other sources say there may even be talk about the need to use an adjuvant at all, given that studies show swine flu vaccine without adjuvant works well and given that the use of adjuvant significantly increases the cost of the vaccine.

But others wonder whether Canada would be able to make that type of change to its contract at this late date.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Study linking flu shots, swine flu raises concern abroad, prompt changes at home
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...xrXRQvzljFetL0g


TORONTO — An unpublished Canadian study that suggests seasonal flu shots raise a person's risk of catching swine flu is raising concern abroad and triggering changes to flu vaccine program schedules at home.

The data, referred to as "the Canadian problem" by some scientists outside this country, are reported to link getting a flu shot last year with double the risk of contracting swine flu this year.

The link, if real, is to mild disease. One person who has seen the study says it seems to suggest that those who got a seasonal flu shot were less likely to develop severe disease if they became infected than those who hadn't received the shot.

Though few people appear to have seen the data, word of the findings has spread like ripples in a pond in recent weeks. Provincial and territorial public health authorities planning two mass vaccination programs for this fall have been struggling with whether to let the unconfirmed findings influence the timing of their flu shot delivery efforts.

Earlier this week some expressed hope of a pan-Canadian approach. But that hope faded by Thursday as it became clear Canada's various jurisdictions were headed in a variety of different directions.

Ontario announced it would vaccinate seniors against seasonal flu in October, but delay the bulk of its seasonal program until later in the winter. Saskatchewan said it may cancel its seasonal campaign altogether. And Manitoba said it is planning for the seasonal program to run as scheduled, but building in the capacity to change course if need be.

"When we look at the overall big picture, we believe that the strategy that we are offering is the safest and (most) effective strategy in terms of moving forward," Dr. Arlene King, Ontario's chief medical officer of health, said as she unveiled Ontario's approach.

Her counterpart from Manitoba, Dr. Joel Kettner, said his province would prefer not to go that route.

"The start-stop, start-stop process is not my favourite option," he said from Winnipeg. "What I say is: Keep going boldly forth, ready to stop on a dime."

Kettner voiced what is likely a commonly held sentiment - a regret that the whole matter has come up at all.

"This is not my favourite way to do public health practice - in the middle of an evolving outbreak, to have to consider preliminary research as an influence on decision making," he said, though he added that he appreciates that if scientists think they've found something of public health significance, they have a duty to air it.

"I fully understand why the authors decided to share this with some people and some people decided to share it with other people. I understand why they might have thought that was an important or good thing to do. But it does create problems."

And not just in Canada. The work, which has been the topic of hours of teleconferences, is causing consternation internationally as well, a senior official of the World Health Organization said Thursday.

Dr. Marie-Paule Kieny, who heads the WHO's vaccine research initiative, said there's a keen interest, internationally, to go through the data in the study and see whether the research is correct or flawed.

"There's really intense international discussions on that," Kieny told The Canadian Press in an interview. "Because now that it's out, everybody feels that we must go to the bottom of it and see what's real there."

She noted in a news conference that Canadian officials are putting together an expert panel to assess the data. Dr. David Butler-Jones, Canada's chief public health officer, said the panel is being conducted at arms-length from the agency and the work is already underway.

Health Minister Leona Aglukkaq acknowledged the data are troubling.

"Of course it's a concern," she said in Winnipeg, where she was meeting with First Nations leaders.

"We'll continue to look at the situation and monitor the situation. Once we have the information, we'll share that information with Canadians."

Drawn from a series of studies from British Columbia, Quebec and Ontario, the work is led by Dr. Danuta Skowronski of the British Columbia Centre for Disease Control and Dr. Gaston De Serres of Laval University.

They have submitted the paper to an unnamed scientific journal and are therefore constrained about what they can say about the work. Journals bar would-be authors from discussing their results before they are published.

"For me, it's very important that we respect the peer-review process as good scientists. Because the implications ... are important," Skowronski said in an interview Wednesday.

"And if there are methodologic flaws, we need to be assured that every stone was turned over to make sure what we're reporting is valid."

Complicating the issue is the fact that scientists elsewhere have looked for a similar effect but have failed to see it. The U.S. Centers for Disease Control has said it finds no evidence of this and Kieny said British and Australian researchers have also drawn a blank when they searched their data.

Kieny said it is important to study the data with an open mind. "If there is something, it's better that it comes out. I think one needs to keep open eyes and a fresh mind and look in all fairness to the results."

Still, she, like others, struggled to come up with a reason for why getting a seasonal flu shot would elevate a person's risk of catching swine flu, noting there is no evidence to suggest that getting the flu shot one year raises a person's risk of catching flu the next.

"The plausibility seems sort of in question," she said.

"It may be a study bias. It may be that something is real," Kieny said during the news conference.

"But certainly the WHO as well as the regulators in all of these countries are looking forward to be able to see the data, to study the data and come with a better understanding of whether this has any chance of indeed putting people at risk, the fact that they have received a seasonal vaccination."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Like several other provinces, BC, PEI, to delay seasonal flu shots for under 65s
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...55at9XeQoj8K9Mw


British Columbia and Prince Edward Island have joined a growing list of provinces that have announced they will delay part of their seasonal flu shot programs this year, decisions which are partially fuelled by concerns raised by controversial and unpublished Canadian research.

The study, by scientists in British Columbia, Quebec and Ontario, suggests people who got a flu shot last year were twice as likely as those who didn't get a flu shot to catch swine flu.

The unconfirmed data have been a source of worry for provincial and territorial public health authorities who are getting ready to roll out two massive vaccination programs this fall and winter.

And they have caused consternation, both abroad and at home, among experts who worry the work will undermine confidence in flu shots and potentially vaccines in general.

"I think it really is unfortunate because either way it's going to set back legitimate public health goals," said Dr. Ross Upshur, director of the University of Toronto's Joint Centre for Bioethics and a primary care physician who has been heavily involved in pandemic planning over the years.

"And as a consequence, we're going to have fractured and inconsistent vaccine policies in all the provinces, which doesn't serve the aim of understanding influenza or better control."

The research - led by Dr. Danuta Skowronski of the British Columbia Centre for Disease Control and Dr. Gaston De Serres of Laval University - is being analyzed by a medical journal and by an independent panel set up at the behest of the Public Health Agency of Canada. Researchers in the U.S., Australia and Britain have looked for and haven't seen the same effect.

Eventually scientists may come to a conclusion that the work is likely right or wrong, but by then the public may have drawn its own conclusions, Upshur said.

"Scientists are used to debating and dealing with the uncertainties," he suggested. "And for the public, it's just: 'Can't trust any of this."'

But Dr. David Patrick, director of communicable disease epidemiology at the BCCDC - and a colleague of Skowronski's - said that while it is difficult to come out with "inconvenient findings" at this time, it is important to put the work to the scientific test.

"These studies are under review right now. We want that process to run properly with the independent international scientific review in terms of getting a good idea about what these studies mean in the long run," he said at a news conference in Victoria where B.C. officials revealed their vaccination plans.

"But we think that we've taken the middle path here, which is rational based on the epidemiology alone, let alone considering these studies."

Besides B.C. and P.E.I., Ontario, Nova Scotia, Quebec and Saskatchewan had announced they will only give seasonal flu vaccine early in the fall to people 65 and older and residents of long-term care facilities. The rationale is that older adults don't appear to be at much risk of catching the pandemic virus, but they are susceptible to seasonal flu viruses.

Pandemic vaccine programs will be rolled out when the H1N1 vaccine becomes available in early November. Following the delivery of that vaccine, these provinces say they will resume giving seasonal flu shots, though some have left open the door to further modifications depending on the state of the science at the time.

New Brunswick, Newfoundland and Labrador and Manitoba are currently proceeding with their normal seasonal flu vaccine programs before the pandemic vaccine rollout. Alberta and the three territories have not yet declared what they plan to do.

Dr. Perry Kendall, B.C.'s chief medical officer of health, said the three-step approach protects against the theoretical risk identified by the study and simplifies the logistical challenges of administering these large vaccination programs over a short period of time.

"Should the perplexing findings of the studies on prior seasonal influenza vaccination be replicated and stand up to critical review and analysis, we will have averted a potential risk scenario," Kendall said as he and other provincial officials announced the province's plan in Victoria.

Prince Edward Island announced it too would go this route.

"This was a complex decision, and we wanted to ensure that our decision for P.E.I. was informed and evidence based," Dr. Heather Morrison, chief health officer for the department of health said in a release.

"This year is a different flu season, but our overall goal is the same; we need to target those most at risk for the flu strains that are in the community this season, to ensure the right people receive the right vaccine at the most appropriate time."

Influenza and public health experts outside this country have dubbed these findings "the Canadian problem," often preferring not to talk about a study they haven't seen suggesting link they hope isn't real.

Several, though, have gone on the record to say they think it will turn out that the work is flawed in some way. A commonly mooted suggestion is that there is a selection bias at work, meaning the type of people studied are not representative of the population in general and therefore the findings can't be generalized.

"There are obviously in any kind of retrospective study many, many options for bias and quirks of methodology to influence the kinds of associations you're looking at - which in this case are of relatively small magnitude," said Dr. John Treanor, an influenza vaccine expert at the University of Rochester in New York State.

Treanor said the lack of a plausible biological explanation for why a flu shot might make one more susceptible to a virus not contained in it makes him skeptical of the findings, though he acknowledges he hasn't seen the data.

"Right now I'd say: 'Gee, you've got this sort of observation that's interesting but kind of small in magnitude and it doesn't really make any biological sense.' So it would take some convincing to make me think it's real," he said.

"Not that it's impossible. But I'd say: 'Gee, you have to be really careful about interpreting that."'

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

I posted the following on EffectMeasure re one Branswell news report:

Having gone back and read multiple articles from Helen Branswell, I agree they are more thorough than most. They are accurate for the most part. It's a step in the right direction and I do not fault news reporters for doing their job which is to sell news.

But Branswell's articles follow the typical news media model and the result is predictable. For example, here is Branswell on the thimerosal issue: http://www.google.com/hostednews/ca...keqg37NttTxij2A

Title: Lack of thimerosal-free pandemic vaccine option leads some planning to pass

It follows the template of looking for controversy and scandal, despite its appearance of accuracy. There is a legitimate story here regarding the beliefs about thimerosal and the effect of those beliefs on a major effort to vaccinate the public, especially the at risk pregnant women.

But consider the amount of verbiage supporting the science. In the first 6 paragraphs describing the mercury fear you have, "experts believe it is safe. It's been used for years in vaccines," as the sole sentence supporting the science.

The next comment on the science is, "they believe some children suffer due to vaccination. Multiple high calibre studies have not supported the claim, but opposition to thimerosal persists in some quarters."

Which "quarters"? It suggests there is doubt about the safety of Thimerosal within the scientific community.

Next we have, "Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion, is convinced it is [safe].

"Personally, no, I'm not concerned about that," says Gardam. "(But) I'm not the pregnant woman getting the injection who's reading stuff about thimerosal and autism and God knows what else."

He admits he is worried that some people who should be in line for pandemic vaccine won't come forward because of the lack of a thimerosal-free option."

Gardam is worried. Those of us in the medical profession who are up on the vaccine research recognize the 'worry' in question is about false beliefs getting in the way of vaccinations. But the lay reader gets the overall impression from this article that the worry is bigger than that.

The report continues, "I have concerns that people won't get it because thimerosal is there," Gardam says. "People's concerns are their concerns," which puts Gardam on the side of the no-Thimerosal option. Again, I recognize the reason is to increase vaccine acceptance. But the impression is Gardam doesn't agree with the PHA of Canada's decision.

The following paragraph has the 'news media patterned' story of government scandal: "The Public Health Agency of Canada refused a request for an interview on the issue. Instead, a media relations adviser emailed material stressing that thimerosal actually adds to the safety of vaccine by preventing contamination that can result in bloodstream infections and abscesses.

"There is no safety reason to avoid thimerosal-containing vaccines," the email says."

The evil government conspirators are brushing off the risk.

The next two paragraphs are good. They make clear statements about the science. These paragraphs are 2/3 of the way down the page. They are countered by the bulk of the article. They are followed with more doubt about the science and more hinting the Canadian public health has made a politically convenient decision rather than a safe decision.


If I wrote this news story, it would be about the science and the problem with people who believe in non-scientific evidence based health claims. I would have written about how much harm the anti-vaxer Mommy web sites have been causing and the potential for deaths because of the false information those web sites promote. That false information, rampant on the Internet is the real scandal here.

Dutch researchers find mutation linked to greater virulence in swine flu virus

Published Wednesday September 30th, 2009

TORONTO - Dutch scientists have reported they have found what was thought to be a key mutation in some swine flu viruses from the Netherlands, a change many virologists feared would give the viruses the ability to cause more severe disease.

But so far the evidence seems to suggest this mutation does not make the new H1N1 virus more virulent, the researchers said Tuesday.

The change, at position 627 on the PB2 gene of the virus, is known to increase the ability of flu viruses to replicate; prolonged viral replication can lead to more serious illness. The mutation has been found in all known human flu viruses, including the three that caused the pandemics of the last century.

"Everybody predicted that this mutation is going to have a big impact on virus replication of the new H1N1," said Dr. Ron Fouchier, one of the authors of the report and a molecular virologist at Erasmus Medical Centre in Rotterdam.

"If you would have asked me three months ago, I would have bet my car on it. But nobody placed that bet because everybody was sure that it would increase (virulence)."

If they had, it seems they might have been able to claim the keys to Fouchier's SUV.

Three people either known or suspected of having been infected with the mutated H1N1 viruses suffered only mild disease. And ferrets infected with a laboratory synthesized H1N1 virus with this change also did not suffer more severe disease. Ferrets are the standard animal model for human flu.

"Given the information that we have at present, we have no indication for increased virulence," said Dr. Marion Koopmans, chief of virology in the infectious diseases laboratory of the National Institute of Public Health, The Netherlands.

"This is a mutation that is in the textbooks as something to look out for, but whether it really confers something to these (H1N1) viruses remains to be seen."

Koopmans, Fouchier and a number of colleagues disclosed the surprising findings through ProMed, a website and mailing list that serves as an early warning system for infectious diseases developments. It is closely scrutinized by scientists and public health officials in the infectious diseases sphere.

The Dutch scientists reported finding two viruses with this change that appear to have been transmitted between mid-July and mid-August in the West Frisian Islands in the north of The Netherlands. The area is a popular destination for Dutch and German campers.

One of the mutated viruses was recovered from a male who had been there and who started developing symptoms on Aug. 9. The second was found in a girl who hadn't been to the area, but whose sister had been camping there at the time. The sister was also sick, but there was no specimen from her to test. Koopmans said the working assumption is that the sister who went camping was also infected with this virus.

The first virus was only discovered in mid-September, when it made its way to Koopmans' lab. An investigation at that point showed the male and the sister had been part of a group of 24 who shared two tents on the island. Most of the members of the camping party reported having been ill.

Koopmans said officials have looked at specimens from the area and from the regions from whence the campers came, but haven't found more viruses with this change.

"There's no evidence yet that this virus has spread any further in Holland," Fouchier said. "Of course we're currently still looking for it. Every virus we get our hands on we check (position) 627. But we haven't found any more."

Labs have been looking for this mutation from the moment the new H1N1 virus was fully analyzed and it was seen it didn't have the same amino acid at position 627 as other human viruses have.

Some scientists even suggested the virus might not be fully adapted to spread among humans because it didn't have this change, but instead had an amino acid at position 627 that is normally seen in avian flu viruses. The pandemic virus, which is a never-before-seen hybrid of swine, avian and human genes, has an avian PB2 gene.

Dr. Richard Webby, head of the World Health Organization's influenza collaborating centre at St. Jude Children's Research Hospital in Memphis, Tenn., said there is good evidence this mutation is associated with adaptation of avian influenza viruses to humans, but the proof that it is linked to severity of disease is less clear.

Viruses with this change show increased virulence in mice and sometimes in ferrets, but not always, he said, suggesting the ferret data probably are more reliable. "I think this is one instance where mice are probably lying a little bit," Webby said.

In some flu viruses this change is known to allow the virus to replicate at cooler temperatures, meaning they can infect the upper airways, rather than the warmer deep lung area preferred by avian flu viruses.

That might actually be a good thing with this H1N1, Webby said, noting autopsies have shown that in severe cases the pandemic virus wreaks havoc deep in the lungs.

Dr. Nancy Cox, who heads the influenza division at the U.S. Centers for Disease Control, warns people should not take too much comfort from the fact this change doesn't seem to make the virus more virulent at this point.

"We just know that influenza can change in unpredictable ways through mutation and reassortment," she said, referring to the process by which flu viruses swap genes with each other.

"The unexpected can arise, and arise very quickly. So we shouldn't write this off. It is causing hospitalization. It is causing fatalities. And in every single case that you hear about, it's a tragedy."

http://www.canadaeast.com/front/article/807713

No link seen between seasonal flu shots and severe swine flu cases: PHAC
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...RqDHHVsAlVYGIfg


TORONTO — A preliminary analysis of data from hospitalized Canadian swine flu cases suggests there is no link between having a seasonal flu shot and developing a severe bout of pandemic flu, officials of the Public Health Agency of Canada said Wednesday.

They said the agency looked at data from hospitalized pandemic flu cases after learning of another, still unpublished study that seems to indicate people who got a flu shot last year had double the risk of catching swine flu compared to unvaccinated people.

The jury is still out on whether or not that study - based on data from three provinces - has found a true effect or is flawed in some way. But Dr. Frank Plummer, scientific director of the National Microbiology Laboratory in Winnipeg, called the lack of evidence of a link between seasonal flu shots and severe swine flu "reassuring."

"The most important question is: Is the seasonal flu vaccine associated with enhanced severity of disease? And there's no evidence whatsoever from Canadian data that there is," Plummer said during a media teleconference. Plummer was speaking about the analysis done by agency staff.

Dr. David Butler-Jones confirmed the Public Health Agency has received an arm's-length, international assessment of the data in the unpublished study; it had commissioned the review to help it sort through this situation, which has been dubbed "the Canadian problem" by some scientists outside this country.

He said the agency will discuss the review's conclusions with the researchers and with the provinces and territories. He said the conclusions will be made public, suggesting the timing of that would become clearer next week.

An Ontario infectious diseases expert said in his opinion, the sooner the review - and the study in question - are made public and can be scrutinized, the better.

"At this point, given . . . the whole bit about this being 'the Canadian problem' ... if you have an external review, you've got to talk about it. You have got to talk about it," said Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion.

"Honestly, my opinion is: It's already out there. It's out there and I would say it's important to be as open and transparent as possible."

The research in question was led by Dr. Danuta Skowronski of the British Columbia Centre for Disease Control and Dr. Gaston De Serres of Laval University. Their work, which is currently being considered by a scientific journal, is reported to have found the puzzling link between getting a seasonal shot last year and contracting pandemic flu. But the cases seen were mild disease.

Data from the United States, Australia and Britain do not show this association.

One person who had read the study said it appeared from it that getting a seasonal shot might actually have a protective effect against developing severe swine flu.

Few in the country's public health community have actually read the study, but it is nonetheless influencing public policy. The majority of provinces and territories have either scaled back or suspended plans to deliver seasonal flu vaccine in October.

Although there are a variety of approaches being taken, the most common plan is to offer seasonal shots in October only to people 65 and older - who are at low risk of catching swine flu - and residents of long-term care facilities. Pandemic vaccine will be offered when it becomes available in November and then seasonal flu vaccine will be offered to people under age 65 when the pandemic vaccine program is completed.

A variation on that theme was announced Wednesday by officials in Nunavut, who said they will not give seasonal flu vaccine this fall and will make a decision on whether to do so at all this year after the pandemic vaccination effort has wrapped up.

Dr. Isaac Sobol, the territory's chief medical officer of health, said the decision will depend on whether seasonal flu viruses are circulating, or have been apparently crowded out by the pandemic virus.

"This year is an exceptional year," Sobol said at a news conference in Iqaluit.

"H1N1 has come out of nowhere. The rules of the game have changed and we're having to be very vigilant and flexible with our decisions."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Surgical masks as good as N95 respirators for blocking flu in hospitals: study
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...YDT7J803FOVmBHQ


TORONTO — Surgical masks appear to protect health-care workers from catching the flu as well as N95 respirators do in most settings, a new and sure-to-be-debated Canadian study has found.

The work, published online Thursday by the Journal of the American Medical Association, is the latest round in a pitched battle that had gripped many in the scientific, infection control and health-care communities.

It's also, it seems, the first published study of a randomized controlled trial - the gold standard of medical science trials - looking at how well the inexpensive paper masks stack up against the more costly moulded dome-like N95s.

"There's been a great deal of discussion. But the discussion has lacked the incredibly important information to really inform the debate. And what this study will do is it begins to lay what I would call an evidence foundation," said Dr. Arjun Srinivasan, a medical epidemiologist with the U.S. Centers for Disease Control's division of health-care quality promotion.

Srinivasan was not involved in the study, but wrote an editorial on it for the journal with Dr. Trish Perl, an infection control expert at Johns Hopkins University in Baltimore, Md.

They praised the study design, though Srinivasan, others and even the paper's lead author categorized this as a first step, not the last word.

"I think the results are valid. But ... a single randomized control trial isn't sufficient to say this is the end of the story," said Dr. Mark Loeb, lead author and an infectious diseases researcher at McMaster University in Hamilton.

Loeb and colleagues randomly assigned 446 nurses from eight hospitals in Ontario to either wear surgical masks or fit-tested N95s last flu season. Fit-tested means the wearer has undergone a process to learn how to form a seal with the respirator around her or his mouth and nose.

The researchers ensured there was a mix of both in the various units involved, to increase the chances the volunteers in each group had similar levels of exposure to influenza.

They also took blood samples at the beginning and the end of the study to look for antibody changes that would signal whether the nurses became infected over the course of the trial.

Only about 30 per cent of nurses in both groups got a flu shot.

Testing showed 23.6 per cent of the nurses who wore surgical masks got infected with flu during the course of the season, compared to 22.9 per cent of the nurses wearing the N95s. The difference is not statistically significant, meaning the masks were no more or less effective at preventing infection than the N95s.

The results are likely to be hotly debated, especially since a study presented last month at the world's largest annual infectious diseases conference came to a different conclusion. Though not yet published in a journal, that work, done in China, found that N95s cut the risk of catching flu on the job by 75 per cent. It showed no protective effect from surgical masks.

Loeb said he hasn't seen the data and cannot explain the differences.

But a concern raised by infectious diseases expert Dr. Donald Low of Toronto's Mount Sinai Hospital might point to a potential explanation.

He noted that all surgical masks are not created equal. Some are high quality but others are very flimsy, he said, noting there is no regulation of the products. On the other hand, N95s and other respirators have to pass quality control testing. Still, Low praised Loeb's study, and said the findings could give people some confidence that surgical masks will offer protection if supplies of N95s dry up in this or a future flu pandemic.

"This is an important study. It's nice to see these results. It does give some confidence, because there always is the possibility that we could be in that predicament," Low said.

In a report issued last month, the U.S. Institute of Medicine recommended N95 use for health-care workers treating or exposed to patients suffering from H1N1 pandemic flu.

That is also the CDC's recommendation, drawn up in the early days of this pandemic. Srinivasan said the CDC is currently revising its guidelines for the protection of health-care personnel and the new guidelines will be released shortly.

Whatever happens, the debate is likely to continue. Beliefs on both side are deeply entrenched, with some saying that N95s should be standard to prevent influenza transmission in health care and others saying that the less expensive and easier-to-work-in surgical masks are sufficiently protective.

Srinivasan and Perl noted, with apparent regret, that the masks vs. N95 respiratory debate detracts attention from measures that are known to lower the risk of catching flu for health-care workers and their patients alike.

Having sick workers stay home. Urging people who are sick with flu-like symptoms not to visit hospitals. Improving hand hygiene among hospital staff. Persuading more health-care workers to get flu shots.

"This type of personal protective equipment, it's the last line of defence," Srinivasan said. "It comes at the end of all of these other measures that we have."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Is it just me, or does ~23% of these nurses catching flu last season seem like an astronomically high number?

My bet is this group of nurses didn't use either type of mask effectively or consistently, which could explain the difference with the Beijing study.

Heck, IMHO if only 30% of them took the flu vaccine, the vast majority don't take infection control particularly seriously to begin with.


MomCares

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Did I miss something: no control group, nurses without masks? Or was that considered to be unethical ?

Without control group, we can't draw any conclusions?

Another possibility is the nurses were not infected at work or they were infected outside of the isolation area where they were wearing the masks. It may be that the flu last year in that area happened to have a 23% attack rate and that reflects the baseline rate. Above that would indicate an increased hazard from caring for infected patients.

You could ethically use nurses not on the medical floor for controls. That wouldn't have been perfect but it would have been useful. But using no masks caring for infected patients would not have been ethical.

No need to change vaccine policy based on Canadian flu shot data: WHO
By Helen Branswell Medical Reporter
http://www.google.com/hostednews/ca...pAyHmP0GWejWPHg


TORONTO — International influenza vaccine experts are apparently not convinced that Canadian researchers have found a true link between getting a seasonal flu shot and catching swine flu.

The consensus that emerged from a World Health Organization teleconference Friday on the controversial data seemed to be that the Canadian findings are likely due to some confounding factor or factors in the data themselves and may not reflect a real increased risk, according to a WHO official who helped pull together the meeting.

"From a WHO point of view, the fact that the findings are not replicated in other countries I think is reassuring for us that this is an outlier, if you like, the unexpected findings that are coming out of Canada," said David Wood, co-ordinator of the quality, safety and standards team of WHO's department of immunization, vaccines and biologicals.

"Most people are still looking at this as some sort of undetected confounding in the data, that for some reason is giving the results that are there."

In an interview from Geneva, Wood was diplomatic. But when pressed, he did admit most experts on the call didn't seem to believe that the unpublished study, based on data from British Columbia, Quebec and Ontario, had found a true link between getting a seasonal flu vaccine and having an increased risk of coming down with a mild case of H1N1 flu.

"Well, yeah," he said. "It's a totally unexpected finding."

"So I think people do then try to think: 'Well, why is this happening? Are there some effects that are just not being detected that are really behind this?' Because it is an unexpected finding. That's the way people tend to think."

The work, which is said to be being considered for publication by a medical journal, contributed to decisions by most provinces and territories to stagger or delay their seasonal flu shot efforts this fall.

Instead of launching full-fledged seasonal flu vaccine programs in October, most have announced they will offer seasonal shots in October only to seniors - who aren't currently at high risk from the pandemic H1N1 virus - and residents of long-term care facilities. After pandemic vaccination efforts are completed, most of those provinces plan to offer seasonal vaccine more broadly.

A couple of jurisdictions - Quebec and Nunavut - will wait until after they've completed their pandemic vaccination efforts before offering seasonal flu shots. At the other end of the spectrum, New Brunswick is going ahead with its regular seasonal flu shot campaign before offering pandemic flu shots.

The Canadian findings, which are reportedly mirrored in data from Manitoba as well, suggest that people who got a flu shot last fall were twice as likely as people who didn't to contract swine flu. But the association, if it is real, is to mild disease. There is no evidence that people who got seasonal flu shots are more prone to develop severe illness if they catch the new H1N1 virus.

Scientists from the United States, Britain and Australia have looked at their data but didn't see the same effect. A number of scientists have speculated that the Canadian data may have some built-in confounders - factors that can produce false results.

For instance, if people who get flu shots are also more likely to seek a diagnosis of swine flu if they get sick, that could make it seem like more of them got the illness when in fact what happened is that more of their illnesses were recorded.

But if the Canadian results are due to some statistical flaws or selection biases, no one on the 4 1/2-hour teleconference was able to put a finger on what exactly the problem is, Wood acknowledged.

And he admitted there may not be a satisfactory answer to that puzzle in the foreseeable future.

"It didn't seem very likely that we're going to be able to . . . suddenly come up with the magic explanation as to why the Canadian data are different to others," Wood said. "In the short term, this is really probably as far as we're going to get."

New studies will likely be needed to get a definitive answer, he said.

Experts say there will need to be prospective studies - following people who get a flu shot forward - rather than the retrospective studies that produced the unusual findings. The evidence from retrospective studies isn't considered as high quality as that garnered from prospective studies.

In the meantime, a summary of the situation will be presented to the WHO's Strategic Advisory Group of Experts on immunization, also known as the SAGE. The group, which meets later this month, makes recommendations for the WHO on vaccination policy.

Wood said he couldn't prejudge what the committee will decide, but said for the moment it doesn't seem like the WHO needs to ask countries to change their vaccination programs for this fall.

"The fact that it's just been seen in Canada at the moment, I don't think that that's going to force global policy changes," he said.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

As U.S. starts swine flu vaccination, vaccine proponents watch with concern
By Helen Branswell Medical Reporter (CP) – 4 hours ago
http://www.google.com/hostednews/ca...nnDLGAWpkEy85GQ


TORONTO — The United States began to vaccinate its citizens against swine flu on Monday, one of the first countries to roll out its portion of what may be an unprecedented effort to immunize upwards of a billion people around the world over the next few months.

Health-care workers in a Memphis, Tenn., hospital were among the first in the U.S. to receive the vaccine, which is currently only available in the U.S. in nasal spray form. Injectable vaccine is expected to start flowing out of the production pipeline soon.

With substantial H1N1 activity in the U.S. at present, officials are relieved vaccine is starting to become available five months after the new virus was first detected.

The relief is tempered, however, with the knowledge that the coming weeks will be challenging at best, given the difficulties of getting still limited amounts of vaccine to the people who want it. If things go badly, they know, the reputations of flu shots specifically and vaccines in general could take a beating.

"I think it will be tough," predicted Dr. Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia and a key figure in the pro-vaccination movement.

Dr. Anne Schuchat, director of the national centre for immunization and respiratory diseases at the U.S. Centers for Disease Control, agreed.

"I think that the positive impact of a successful program could be huge. And the unintended consequences of problems in the program would also be huge," Schuchat admitted.

"So I think that public health and the health-care system do feel a lot of pressure in trying to make this go as smoothly as possible. And then on top of that we do have this race against the virus, which is continuing to cause disease around the world."

The U.S. is not the first to begin to vaccinate; China began a few weeks ago. And Australia started to offer pandemic flu shots last week.

Canada is currently only scheduled to begin vaccinating in early to mid November, though Chief Public Health Officer Dr. David Butler-Jones has said he could ask Health Canada to release the vaccine a few weeks earlier under special licensing provisions if the risk from the virus seemed to increase.

Eventually, the World Health Organization has predicted, three billion doses of the new H1N1 vaccine could be produced over 12 months. It remains unclear whether global delivery systems are in place to administer so many doses. It's also unclear whether there is that much demand for vaccine against this relatively mild pandemic strain.

In the U.S. and Canada, poll after poll shows somewhere around half the population - sometimes less - plans to get a flu shot. While that's better than the uptake rate for seasonal flu vaccine - last year just under 30 per cent of Canadians over age 12 got a flu shot - it is not as high as officials would like to see.

Dr. Michael Osterholm, an infectious diseases expert at the University of Minnesota, said the population at this point breaks down into three groups: Those who are eager to get the vaccine and who will be annoyed by any delay; those who are undecided about whether to get it and who plan to watch how the roll out unfolds before making up their minds; and those who either reject vaccines in general or flu vaccines specifically.

Any signs of adverse reactions that might be linked to the vaccine will drive away the second group, said Osterholm, who is director of the university's Center for Infectious Diseases Research and Policy.

And Offit said the third group will jump at the opportunity to discredit the vaccine if and when such events arise. He admitted that prospect has the pro-vaccine forces essentially holding their collective breath.

"Of course," Offit said. "Because I think when the anti-vaccine groups get a hold of something, they're very good at it."

"They're very good at public relations. They understand how to get the ear of the media and how to get the ear of Congress."

Schuchat and colleagues at the CDC have been trying to inoculate the program against the impact of that kind of event, warning that even though these vaccines should be as safe as seasonal flu shots, things will happen once mass vaccination starts. Pregnant women will miscarry. People will have heart attacks. Rare neurological disorders may occur.

But these things happen all the time among people who haven't just received a flu shot. Determining whether the events were caused in some way by the vaccine or - as experts think is more likely - are mere coincidences will be critical. Unfortunately, the work needed to answer those questions takes time.

"If we detect a signal we'll need to investigate it carefully and even with rapid investigation, it may take some time," Schuchat said.

"I think that patience is a hard thing to have when there's disease around us or vaccination needs to occur quickly. So I think expectations about how quickly we'll be able to understand signals - that's a tricky issue."

Osterholm said the situation is made more difficult still by the fact that there will be glitches in distribution and the fact that no one knows what is going to happen with the virus.

If there appears to be an increase in reports of deaths among children and pregnant women, demand will rise, he predicted. But if severe cases remain rare and the illness is perceived as mild, people could decide to take a pass.

"We're not quite in Never Never Land, but we are charting previously uncharted waters, because of all these issues," Osterholm said.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

It seems that the Canadian timing will work out just fine, since for whatever reason -- maybe earlier school starts -- this second wave seemed to start in the south and work its way northward.


Window to move up H1N1 vaccine closing; feds likely to stick with early Nov
By Helen Branswell Medical Reporter (CP) – 13 hours ago
http://www.google.com/hostednews/ca...0RyiK4ntzS0o0oA


TORONTO — The window of opportunity for accelerating the pandemic flu vaccination program in Canada may be starting to close, unless word of a change of plans comes soon, experts suggested Tuesday.

But despite pressure to speed up the start of the program, the country's chief public health officer continued to insist that the projected start date of early November is still the target.

The early November start will allow Health Canada to follow the regulatory process it set out for approving the pandemic vaccine, Dr. David Butler-Jones said Tuesday.

Butler-Jones had recently said that if the risks of waiting to November started to outweigh the benefits of following the established regulatory pathway, the vaccination program could be brought forward a bit.

"(But) we're now into October ... (and) we're not seeing any of those conditions being met," Butler-Jones said in an interview with The Canadian Press.

"So at this point I'm anticipating that the regular regulatory process with a target that we can start immunizing by the first week of November, that that should all roll out fine."

With that point approaching, provinces and territories need to know when they will start taking possession of vaccine so they can finalize plans for what public health officials hope will be the biggest mass vaccination effort in the country's history.

Plans are currently set for clinics to take place in November. Those plans cannot be changed on a dime.

Dr. Perry Kendall, British Columbia's chief medical officer of health, said provinces and territories would need at least a week or two of notice to get clinics organized and staffed if the start date is going to change.

"If vaccine were available today, we'd still need time to train the delivery system for this specific vaccine, arrange clinics, advertise, review consent forms, pre-position vaccine supplies, ensure labelling and mixing (is) understood by all, etc.," Kendall said in an email.

Given that the first week of November is just three-and-a-half weeks away, unless word of a change comes soon there may be little gain from moving up the program start.

Meanwhile, Canadian TV sets tuned to U.S. TV channels are seeing images of Americans already being immunized against the virus.

The U.S. effort began Monday, with 2.4 million doses of a nasal spray vaccine expected to be shipped to states by the end of this week. That vaccine, FluMist, is not currently licensed in Canada. Injectable vaccine supplies will start to flow in the U.S. next week.

But where the U.S. is buying its pandemic vaccine from five suppliers, Canada has purchased its 50.4 million doses from a single producer, GlaxoSmithKline. The U.K.-based pharmaceutical giant has a flu vaccine production facility in Ste-Foy, Que.

GSK's European plant, based in Dresden, Germany, is already shipping {SF} vaccine. But it started making the pandemic product sooner than the Quebec facility, a senior GSK executive said in a media briefing on Monday.

Dr. Thomas Breuer explained the European production facility has two buildings and was able to start making pandemic vaccine in one while finishing its seasonal flu product in the other. The Quebec plant has only one building, so it had to finish the seasonal shots before starting on the pandemic product.

"It is currently envisioned that product will come out of the Canadian facility end of October, beginning November," said Breuer, a senior vice-president and chief medical officer for GSK.

But Dresden's quicker start will help speed vaccine approval here, Butler-Jones said.

Data generated by GSK in clinical trials in Europe will be used to approve the Canadian vaccine, he said. Health Canada will use those data to assess the safety and immunogenicity of the vaccine - in other words, its ability to induce a protective response.

"It's the same vaccine. It's not made in the same plant but all the processes and everything are the same," Butler-Jones said.

"So there's no need to wait for the Canadian confirmatory data which will come later. Because it's exactly the same process, the same vaccine from the same company."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Canadians don't see H1N1 as a personal risk, only one-third plan to take shot
By Helen Branswell Medical Reporter (CP)
– 6 hours ago
http://www.google.com/hostednews/ca...eMtNmzW1_5Opb6Q


TORONTO — Canadians don't seem to see the H1N1 virus as a personal threat, and few currently plan to get vaccinated against the virus, a new poll indicates.

The Canadian Press Harris-Decima poll suggests interest in the swine flu vaccine has declined in Canada, with only a third of people now saying they will get the shot, compared to 45 per cent in late August.

"I think that that's a significant decline. And it indicates ... either a higher level of confusion over what the right approach is, or a lower sense of risk," Doug Anderson, senior vice-president at Harris-Decima, said Thursday.

Ironically the poll findings come at a time when the federal government is under intense pressure to fast-track approval of the H1N1 vaccine so that immunization efforts can begin sooner than the projected early November launch. Canada has purchased 50.4 million doses of the pandemic vaccine.

"They're certainly disappointing and maybe a bit dismaying," Dr. Perry Kendall, British Columbia's chief medical officer of health, said of the findings.

Kendall said a national public awareness campaign will be launched to try to improve understanding of the benefits of the vaccine and to persuade people the product is safe, effective and in their best interest to take.

"At the end of the day I rather suspect that it will depend on people's perceptions of risk," he said of the likely uptake.

The poll, conducted from Oct. 1 to 5, suggests at this point people don't believe this virus will have much impact on their lives.

Only 11 per cent of people described themselves as very concerned about H1N1, and 25 per cent said they were somewhat concerned. Nearly two-thirds of people said they either were not very concerned or weren't concerned at all about H1N1

Three-quarters of Canadians surveyed felt they would be exposed to seasonal flu this winter, but only 45 per cent felt they would be exposed to the pandemic virus. {i.e. these people are BADLY misinformed since SF is crowding out seasonal flu}

Only five per cent of respondents felt they were very likely to contract swine flu, and 72 per cent felt they were not that likely or not likely at all to get infected with the new virus. In contrast, 18 per cent felt they were very likely to get sick with seasonal flu.

The apparent belief that seasonal flu poses a greater risk at this point than the pandemic virus flies in the face of the virological reports of what flu viruses are circulating in the world at this point.

While they haven't disappeared altogether - and while no one can predict what the winter will bring - there has been limited seasonal flu activity globally since the emergence of the new virus earlier this year.

"I think it speaks to the fact that although the media have been accused of hyping this (H1N1), clearly the message that seems to have gotten through is people ... don't see it as a threat," said Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion.

"It would be far easier to go down this road if it was a more virulent virus. And I'm not wishing that it's a more virulent virus. That's one of the reasons why it's got us in this weird sort of pickle."

The poll suggests half of people don't plan to get any flu shot at all this year. Of the 50 per cent who do, 27 per cent said they would get both seasonal and pandemic flu shots. In total, 33 per cent indicated they would get an H1N1 shot and 36 per cent said they'd get a seasonal flu shot.

Those numbers actually align pretty closely with the percentage of the population that rolls up its sleeve for flu shots in regular years - further proof, Gardam said, that suggests people don't see the pandemic virus as a greater-than-normal threat at this point.

"They look at it as sort of same-old same-old. And the majority of people don't get vaccinated for seasonal flu, so why would they change now?"

Dr. Kumanan Wilson, a public health researcher at the Ottawa Hospital Research Institute, said the findings illustrate that the public is confused about the various viruses and the two vaccines.

"This isn't easy to understand," he admitted.

"There's a lot of confusion about how worried they should be about both the seasonal flu and H1N1. And I think the message from this is that these are the questions that public health officials need to answer."

The pollsters interviewed 1,000 people across the country for the survey, which has a margin of error of 3.1 percentage points, 19 times out of 20.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

US study shows no problem giving seasonal, H1N1 vaccines at the same time
By Helen Branswell (CP)
http://www.google.com/hostednews/ca...FadYDxT4o40O4Vg


TORONTO — New data from U.S. studies seems to confirm that only one dose of H1N1 vaccine will be needed to protect adults and seniors and that giving seasonal and pandemic flu shots at the same time should be fine, the head of the National Institute of Allergy and Infectious Diseases said Friday.

Testing showed that adults and seniors who received a second dose of the pandemic vaccine didn't get much additional benefit from the second shot, Dr. Anthony Fauci said in a media teleconference.

The response to one dose in both groups was already sufficiently strong to suggest that the vaccine should offer good protection and it has been the working assumption in the U.S. that adolescents and adults would only need one shot.

"We have data that looked good and suggesting to us (that) one dose of 15 micrograms would be sufficient for the adults and elderly," said Fauci, who added there was "no substantial difference between the second dose and (antibody levels seen at) 21 days following the first dose."

"That confirms the concept that a single dose of 15 micrograms is sufficient enough to induce a robust response."

Fauci also revealed preliminary data from another study looking at whether it was safe to give both seasonal and pandemic flu shots at the same. Both protect against an H1N1 virus - though the viruses are sufficiently different it is thought vaccine against one would not protect against the other.

There were theoretical concerns, though, that giving two flu vaccines at once might interfere with the immune system's ability to generate a good response to all the viruses covered in the shots. Seasonal flu shots protect against three families of viruses - seasonal H1N1 and H3N2, both influenza A viruses and an influenza B virus.

"The vaccine when given simultaneously does not impair the immune response to either of those (shots)," Fauci said.

"That I believe is going to be important as we roll out the vaccination program. And individuals will go to their offices and would like at the same time to get both vaccinations."

Fauci said there were no unusual side-effects seen in the people who received the two vaccines together. "We're seeing pain, redness and perhaps some swelling that we see very frequently with injectable vaccines."

He said his institute is now launching new trials, studying the safety and effectiveness of the vaccine in people with asthma. Other studies will look at safety and dosing requirements in two groups of people living with HIV - pregnant women, and children and adolescents.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Toronto hospitals lag behind rest of province in flu shots for staff
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...s202mSNUHBXU44g


TORONTO — You might have thought Toronto's experience with SARS would have made health-care workers in the city's hospitals more likely than their provincial counterparts to get a flu shot. But a new report suggests you would have been wrong.

The report, from Toronto Public Health, shows that for the past three years, flu shot uptake rates among staff of Toronto's hospitals and long-term care facilities have been lower than the provincial median rates.

Hospitals are required to provide the figures annually to Toronto Public Health. Last year Chief Medical Officer Dr. David McKeown warned the institutions that from this year onward, he would be making the figures public.

"I think transparency can play an important role in drawing attention to the issue and emphasizing the importance of immunization for health-care workers," said McKeown, who explained he thinks flu immunization rates should be included among the hospital-specific patient safety indicators the province is now collecting and reporting - things like rates of C. difficile and drug-resistant Staph.

"I think one of the things that would be a good idea is if patients and family members asked the institution how they're doing in influenza immunization. Ask your health professional."

The median rate among acute care hospitals in the city was 42 per cent, and 55 per cent among the staff of complex continuing care hospitals. The rates among long-term care facilities - home to those in society at greatest risk from flu - were generally higher, though at the low end of the scale only 19 per cent of the staff in one such facility got a flu shot last year.

The report doesn't list separate provincial rates for acute care and complex continuing care hospitals, but said the median rate provincially for staff immunization against flu in long-term care was 77 per cent last year.

McKeown said the numbers - on Toronto Public Health's website, with tables listing individual institutions - might be an eye-opener for some.

"People who work in this field recognize that it's a challenge to get health-care workers to be immunized against influenza. But I think most patients and families would be surprised by how few health-care workers are immunized," he said.

"There are a number of institutions in which only one in four to one in five of the staff are reported to have been immunized. Those numbers are very low."

Some of the hospitals involved in the city's SARS outbreak were not as high up the list as one might have expected. For instance, Scarborough Grace Hospital - the first hospital hit and the epicentre of the first wave of the outbreak - had a median flu immunization rate of only 24 per cent.

On the other hand, the three hospitals of the University Health Network reported a rate of 63 per cent, the highest among Toronto's acute-care hospitals.

The Ontario Ministry of Health recommends that institutions strive for a flu immunization rate of 70 per cent. But McKeown said that should be a floor, not a ceiling.

And he's hopeful the emphasis the H1N1 virus is placing on influenza means next year's report will be more impressive.

"I'm hoping that the amount of attention that's being paid to influenza this year will help shine a light on this particular aspect of our efforts to protect people against influenza," McKeown said.

"We're expecting to have a busy flu season. And we need those health-care workers on the job and not contributing to the problem."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Without high-tech care, H1N1 death toll could soar, studies suggest
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...fvr0gEBvYl7Foew


TORONTO — Developing countries with limited access to advanced health-care facilities may be in for a rough ride with swine flu and even countries with high-tech ICUs may find themselves pushed to the limit as their hospitals struggle to save gravely ill H1N1 patients, new studies suggest.

The studies, which compare outcomes among H1N1 patients admitted to intensive care units in Canada and Mexico, showed the death rate in the latter was more than double that seen among Canadian patients. Just over 40 per cent of critically ill Mexican patients succumbed to their illness by day 60, compared to 17.3 per cent of Canadian patients by day 90.

"I think this H1N1 (virus), it's not going to be the one that people would say 'Oh, my God, that killed off X per cent of our population'," said Dr. Rob Fowler, a critical care specialist and senior author of both studies.

"But we're going to see large numbers of patients that have illness, a subset that are critically ill and in different parts of the world it's actually going to translate into lots of people dying that wouldn't have otherwise died - especially so if you can't support them (medically)."

The studies were published online Monday by the Journal of the American Medical Association. Their publication was timed to coincide with Fowler's presentation of the data at a conference staged by the European Society of Critical Care Medicine.

Dr. Michael Osterholm, an infectious diseases expert at the University of Minnesota, said the findings should serve as an eye-opener for the large segment of the public that has dismissed swine flu as a mild form of influenza.

For many it is, but "for a very small number of patients, this illness is hell," said Osterholm, director of the Center for Infectious Diseases Research and Policy.

An editorial that accompanied the package said saving that group of patients depends on the ability of medical teams to employ sophisticated mechanical ventilatory support. There may not be enough of these beds available or the trained staff needed to deliver this kind of care, the authors warned.

"Clinicians and hospitals should take note that the rescue therapies used in these studies have the potential to cause harm if not implemented in a co-ordinated manner," noted Dr. Douglas White and Dr. Derek Angus, critical care physicians at the University of Pittsburgh.

They suggested hospitals need to make plans for how they will handle an influx of severely ill cases, noting that while the number of such cases during the spring wave was modest, the burden they place on hospitals in both Canada and Mexico was "sobering."

"Any deaths from 2009 influenza A (H1N1) will be regrettable, but those that result from insufficient planning and inadequate preparation will be especially tragic," Angus and White said.

As they and many others have noted, this pandemic is not triggering the volume of severe disease experts feared the world might see with the first pandemic of the century.

While it's not currently possible to estimate what percentage of people who catch the virus need to be hospitalized, it is clear that for most people, H1N1 is indistinguishable from regular influenza.

But a small proportion of patients became profoundly ill and did so quickly. Fowler said those who went into this sharp decline generally ended up in the ICU within about 24 hours of entering hospital.

There medical teams battled to save their lives, hooking these patients up to ventilators that breathed for them or even the types of bypass machines - called extracorporeal membrane oxygenation, or ECMO - used in cardiac surgery.

These patients are far younger than those hospitals generally see dying from flu or the complications of flu, said Dr. Anand Kumar, an intensivist who treated many of these patients in Winnipeg hospitals this spring and the lead author on the Canadian study.

He said any loss of life in an ICU is difficult, but it is especially hard when the cases are like those this virus often kills - younger adults and middle-aged people who were relatively healthy before they contracted the virus.

"To lose somebody 24, 25, 30, 40 years old - it's just not their time," Kumar said.

He said he's gotten emails from intensivists all over asking why public health authorities are calling this flu mild, "because it's certainly not mild from an ICU context." The World Health Organization also objects to the use of the term mild to describe this pandemic, calling it moderate.

Where resource-intensive therapies are available, chances are decent that H1N1 patients will pull through, these and other recently published studies have found.

But where they are not, the death toll will be higher, said Fowler, a critical care specialist at Toronto's Sunnybrook Health Sciences Centre.

"This is a young, relatively healthy group of patients that has their lungs fail. And if you can throw the book at them to get their lungs through this, then you have a pretty good shot at keeping them alive," Fowler said.

"And I think in places that aren't able to do that, well ... you have a much lesser likelihood of making it."

The comparison of the outcomes between the two patient groups - 168 confirmed or probable cases in Canada, 58 in Mexico - provided some other important information.

Fewer of the patients from Mexico were treated with antiviral drugs like Tamiflu, allowing the authors to compare the outcomes of the patients who received the drugs and those who did not.

Antiviral treatment is recommended for all patients sick enough to require hospitalization, even if treatment is commenced later than the 48-hour window in which therapy is supposed to start for best results. In Canada most of the patients would have received the drugs, so there would be no way to assess whether they were helping or not.

But by comparing the data from the two countries, the authors showed that people who received the drugs {antivirals} were seven times more likely to survive than those who did not.

"People should get these drugs," Fowler said.

The Canadian study also found a disproportionately high percentage of the severely ill cases were women - 67.3 per cent. The virus is especially tough on pregnant women, but the pregnancy doesn't account for all of the excess in women, Fowler said.

He admitted the gender imbalance among severe cases is puzzling.

"I have no idea why that could be the case," Fowler said. "But that does seem to be something that has been consistently reported ... that critically ill women are over-represented relative to critically ill men."
******************
{Maybe the women had disproportionately cared for ill children, resulting in higher viral loading??}

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Good point. I hadnt realized simply being female put us in a higher risk group. 67% - that is a 2 to 1 ratio. Pregnant women skew that a bit, but still...

__________________ 
.
.

Roscoe and Miss Priss 

Turkeys at Ontario farm infected with swine flu
By HELEN BRANSWELL The Canadian Press
Wed. Oct 21 - 4:46 AM
http://thechronicleherald.ca/Canada/1148711.html


TORONTO — A turkey breeding operation in southern Ontario has been hit by the H1N1 virus, the province’s chief human and animal health officials reported Tuesday. It is only the second time turkeys have been reported to have been infected with the pandemic virus.

The outbreak likely poses no immediate threat to human health, and in particular should not have an impact on the safety of the food chain, the officials said, noting influenza cannot be contracted from well-cooked meat.

But experts do worry about the possibility that mutations could occur if flu viruses jump from one species to another and back again.

And some also expressed concern that news of the discovery could turn some consumers off turkey, even though in terms of flu transmission people probably pose a bigger risk to livestock right now than the other way around.

"From my perspective as a veterinarian, I see the danger being to the economic well-being of the animal industry that’s involved, and in food security — having food," said Dr. David Halvorson, an avian influenza expert at the University of Minnesota.

The finding was announced by Dr. Arlene King, Ontario’s chief medical officer of health, and Dr. Deb Stark, the province’s chief veterinarian, both of whom refused to identify the affected turkey operation.

But their efforts to shield the company turned out to be futile. An industry group, the Turkey Farmers of Canada, posted a news release on their website announcing the outbreak had been discovered on a farm near Kitchener owned by Hybrid Turkeys.

Later, the company confirmed the report. Dr. Helen Wojcinski, a veterinarian and Hybrid’s manager of science and technology, said turkeys in one barn on one farm experienced a drop in egg production — the telltale symptom of influenza infection in turkeys.

The barn, which contained 3,500 turkeys, is under quarantine. Wojcinski said it is expected the outbreak should run its course in about two weeks, at which point a decision will be made about what to do with the turkeys.

The birds are not free-range, meaning they live indoors under high biosecurity conditions. Wojcinski said the most likely source of the infection was a person with access to the barn.

King said local health officials are interviewing 19 people who had contact with the operation, trying to determine who might have brought the infection in to the birds — and if anyone contracted it from them.

So far one person has been identified as having had influenza-like illness, she said, though it’s not yet known if the person actually had the pandemic virus. Nor is it clear whether the person’s illness predated the outbreak among the turkeys or followed it.

King said the incident serves as a "clarion call" to poultry and other livestock workers that they should get vaccinated with both seasonal and pandemic flu shots.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Vaccine additive {used in Canada, not US} helps immune system respond to, protect against flu
By Helen Branswell (CP) – 3 hours ago
http://www.google.com/hostednews/ca...iAN-5XmmTOdqbqg


TORONTO — Six months ago, most Canadians probably didn't know what a vaccine adjuvant was.

But now, as Canadians and many Europeans mull over whether to line up for an H1N1 flu shot that includes an adjuvant, many have Googled this addition to their vocabularies. And lots are wondering whether they are comfortable with the idea of having vaccine mixed with one of these additives injected into their arms.

Some question whether H1N1 vaccine with adjuvant is safe for children. It's an issue that's bothering Will Murphy, the father of a 23-month-old boy.

"We have deep concerns about making sure we do the right things that are the safest for him," says Murphy, a marketing professor at the University of Saskatchewan in Saskatoon.

He has a lot of questions. And he's disconcerted by some of what he's read on the Internet. "The wonder of the web today, of course, allows us perhaps more information than we end up comfortable with."

Based on what they read online, Murphy and his wife had pretty much decided to ask for unadjuvanted vaccine for their little guy. So they were dismayed to learn last week the adjuvant-free product won't be available for another few weeks, leaving them to choose between waiting longer or giving their son a vaccine they have concerns about.

The Murphys aren't alone. There's a lot of confusion and a fair amount of misinformation out there.

So as Canada embarks on its H1N1 vaccination program, let's explore what these compounds are, why Canadian vaccine will contain an adjuvant and why your arm might be a little bit sorer this year if you decide to get a flu shot.

Q: What is an adjuvant?

A: The word - which is pronounced ADD-joo-vant - comes from the Latin adjuvans, meaning "to help." That pretty much tells the tale.

Adjuvants are additives that help the immune system respond to a vaccine. They seem to work by enlisting more parts of the immune system in the fight against targeted virus or bacteria than do vaccines that don't contain adjuvants.

The concept may seem new to us, but adjuvants have been used in vaccines for decades. The most commonly used adjuvant, alum or aluminium salts, is used in some currently marketed vaccines, such as some made to protect against diphtheria, tetanus and pertussis.

Even the earliest vaccines contained adjuvants, albeit inadvertent ones.

Current manufacturing processes place a heavy emphasis on purification processes. But in the old days, vaccines were far more of a soup of viral or bacterial bits and bobs.

Those vaccines were more "reactogenic" - meaning they caused a lot more local reactions (a.k.a. sore arms) than modern vaccines do. But immunologists admit they probably also worked better.

"The general impression was that when you left all the 'junk' in there - which isn't really junk, it's just parts of the virus - and you didn't purify it, that you were probably providing a subliminal adjuvant in your regular vaccine that was never listed as being an adjuvanted vaccine," says Dr. Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases.

Q: Why is Canada buying adjuvanted vaccine?

A: The World Health Organization asked countries to use "antigen sparing" approaches to pandemic vaccination. Using an adjuvant is one of the main antigen sparing options available. (Antigen is the vaccine component that elicits the immune response.)

One of the major benefits of adjuvants is that they allow vaccine to be stretched. When you add an adjuvant to H1N1 vaccine, a dose that would have vaccinated one person can be used to protect four.

Global flu vaccine production capacity is limited. And while affluent countries like Canada, the U.S., Japan and those of Western Europe have vaccine contracts, most countries don't. So the more adjuvanted vaccine developed countries use, the less antigen they need. And that means more will be available for developing countries.

Q: So we're using vaccine with adjuvant to benefit someone else?

A: That's part of the reason. But it is also true that Canada can get its entire vaccine order a lot quicker if it takes the equivalent of a quarter dose to vaccinate each individual.

Studies have shown there are benefits to individuals as well. For instance, adjuvanted vaccine offers more of what's called cross-protection. When flu viruses mutate, vaccine can become less effective because it's no longer on target. But a vaccine with adjuvant can produce a good immune response to viruses that are similar but not exactly the same as the vaccine target.

There's also a chance one dose of adjuvanted vaccine would suffice for everyone, even young children. Preliminary data released last week by GlaxoSmithKline - the makers of Canada's H1N1 vaccine - shows even young children got what looks like a protective immune response from one dose of vaccine.

Children under 10 are currently slated to get two shots, at least 21 days apart - a regimen that will be a figurative pain for parents and a literal one for kids. But Canada's chief public health officer, Dr. David Butler-Jones, says that recommendation may be revised if further data supports a one-dose approach.

Q: But what's this about adjuvanted flu shots hurting more?

A: Let's be clear. We're not talking about excruciating pain, we're talking about a bit more of a sore arm than usual - though some years seasonal flu vaccine packs a bit of a wallop too.

About the pain: The adjuvant causes some inflammation at the site of the injection, a process that activates parts of the immune system.

"Invariably adjuvants give you more pain, swelling," Fauci says. "But as far as prolonged or long-term systemic effects, there have been no good data to indicate (that) at all. In fact, the data to the contrary have shown, that it's really quite safe."

Q: What is the safety record for adjuvants?

A: Alum has been used safely for decades. But it doesn't work particularly well with influenza vaccine. So several flu vaccine manufacturers have developed new adjuvants. Novartis has one called MF59. GSK has one called AS03, which is being used in Canada.

MF59 has been used for more than 10 years in flu vaccine in Europe. According to a fact sheet from Novartis, the adjuvant has been tested in 28,000 people in 60 clinical trials and has been given to more than 40 million people, albeit mostly older adults. It's used in a vaccine designed to help seniors - whose immune systems are waning - get good protection against influenza.

AS03 is newer and isn't in GSK's seasonal flu vaccine. But the company has been testing an AS03-boosted vaccine to protect against H5N1 avian flu and a total of 41,000 people have received AS03 in clinical trials, says Dr. Thomas Breuer, head of global clinical development and chief medical officer of GSK Biologicals.

In addition, as of late last week 150,000 people had received GSK's H1N1 vaccine containing AS03.

To date, there have been no red flags.

Q: What are adjuvants made from?

A: There are a variety of adjuvants, but the ones used with flu vaccine are oil-and-water emulsions. The recipe may change a little from company to company and the mechanism of action may differ a little as well, says David Wood, co-ordinator of the quality, safety and standards team of WHO's department of immunization, vaccines and biologicals.

GSK's Breuer says AS03 is made from Vitamin E, polysorbate (a widely used component of medicinal products) and squalene, an oil.

Q: Isn't squalene dangerous? Didn't it cause Gulf War Syndrome?

A: No and no.

It may have a nasty sounding name, but we all have squalene (pronounced SKWAY-lean) in our bodies. We need it to synthesize cholesterol and steroid hormones. And the stuff is ubiquitous - it is found in all animals, in plants, and in a variety of foods, cosmetics, over-the-counter drugs and health supplements, according to the World Health Organization.

"It is part of our natural metabolism that allows us to make the kinds of molecules that enable us to survive," says Dr. Paul Offit, an immunologist and vaccine expert at Children's Hospital of Philadelphia.

"Take squalene out of your body, and you die. Take squalene out of Girl Scout cookies and they don't taste as good."

As for the supposed Gulf War Syndrome link, it isn't true.

The claim is that anthrax vaccines given to U.S. soldiers fighting in the Gulf War contained squalene and generated anti-squalene antibodies that triggered disabilities. But the vaccines given to those troops did not contain squalene, the WHO and others have reported.

And a study published in 2006 showed that anti-squalene antibodies can be found in the blood of people who have never been vaccinated with a vaccine containing squalene.

"The objective scientific evidence is that these things are safe. That they are not linked with Gulf War Syndrome. That they don't promote autoimmune disease. That's what the objective scientific evidence says. But it's not what you read on the blogs and on the Internet," Wood says.

Q: What's that about autoimmune disease?

A: "Whenever you induce a heightened immune response, there's always the concern that you're going to trigger aberrant immunological reactions that lead to autoimmune diseases," says Fauci. "But thus far the adjuvants that have been used in Europe ... have a very good track record of safety."

The head of GSK's adjuvant program, Dr. Nathalie Garcon, says the adjuvants don't rev up the immune system throughout the body, they act only at the site of injection. The immune messengers created there do travel from the injection site, but that's not the same as turning up the valves everywhere.

A trial Garcon did neatly illustrates the point. Some people were given flu vaccine with ASO3 mixed in, while others got a shot of flu vaccine in one arm and AS03 in the other. When the vaccine and adjuvant were not given together, the boosting effect was not seen.

Q: Squalene used commercially is sourced from shark's liver. Does that mean people with fish allergies should avoid this vaccine?

A: Garcon says no. Allergies are a reaction to proteins, but squalene is a lipid (fat).

"There's no known allergy to any lipid whatsoever. And because squalene is a constituent of the human body, you don't react against it," she says.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Size of vaccine order, paperwork turn family docs {in Canada} off H1N1 shot delivery
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...TrvWsSmAaL2MOfg


TORONTO — Family doctors in some parts of Canada have been slow to sign up to deliver H1N1 vaccine to their patients, pointing to a number of obstacles they say are discouraging them from giving the shots.

In Ontario, a requirement that doctors' offices order vaccine in 500-dose lots has been deterring some. Others objected to an initial demand that they sign a contract and provide a weekly line listing for every dose delivered - unnecessary paperwork at a time when everyone is pressed for time, critics say.

"Some people think it's money. I don't think it's about money," said Dr. Doug Mark, a general practitioner and president of the grassroots Coalition of Family Physicians of Ontario.

"I think it's come down to the process, that it's very cumbersome and time consuming for doctors.... The government is making things just too complicated and doctors, we're just throwing up our hands in the air and saying: 'You do it."'

"That's what a lot of doctors are saying."

Not all provinces are asking family physicians to be involved in the rollout, planning instead to direct people who want vaccine to mass immunization clinics. And some intend to start with mass clinics but plan to provide vaccine through family practices later.

"I'm aware that there have been a lot of conversations in various fora with family physicians," said Dr. Joel Kettner, Manitoba's chief medical officer of health.

"There is a mixed view. There are some (family doctors) that would like to be giving the vaccine themselves. There are others who understand that there are efficiencies in sending their patients to clinics."

In some provinces where family physicians are part of the rollout, a few of the obstacles identified by Ontario physicians have been taken care of. In British Columbia, for instance, provincial health authorities are breaking up the 500-dose lots into smaller batches so doctors can order only what they need.

Late Wednesday, Ontario's Ministry of Health said it would too.

"We do have the capability at the ministry to repackage," said spokesperson David Jensen.

"So we can repackage them down to 100-dose packages. So we can do that for remote areas and also we can do that for primary care providers as well."

In the Vancouver Coastal Health Authority, the largest health region in B.C., family doctors are delivering the bulk of the vaccine that is going out.

But in Toronto, where doctors were invited to take part in the program, so far only 500 of 4,000 community-based doctors have indicated they are willing to take on the task, said Dr. Barbara Yaffe, associate medical officer of health for Toronto Public Health.

Dr. Suzanne Strasberg, president of the Ontario Medical Association, said Wednesday that her organization has been negotiating with provincial authorities trying to lighten the bureaucratic load the vaccine program would impose on family doctors. The OMA wants members to take part, Strasberg said.

"There was going to be quite a bit of paperwork that had to be done," she said.

"We've had a few concerns from physicians. But I believe the vast majority of physicians, once they've heard the clarification around the information, are ready and willing to give the vaccine."

Jensen said some amount of record keeping is critical. But he said Ontario has developed an electronic form "to make the task as easy as possible for health care providers so they can focus on the immunization and not the paperwork."

But paperwork isn't the only concern.

The size of the vaccine lots has been problematic - 50 10-dose vials, with 50 vials of adjuvant, a boosting compound that must be mixed with the vaccine at the point of administration.

And mixing the two is a fussy and time-consuming process.

Unlike B.C., Ontario has until now had an all or nothing policy. And some doctors wouldn't have the need - or perhaps the fridge space - for that much H1N1 vaccine.

"That can be a barrier in a smaller office where you don't have adequate storage space, definitely," said Dr. Sarah Kredentser, president of the Canadian College of Family Physicians.

Dr. Allison McGeer, an infectious diseases expert in Toronto, said while the 500-dose boxes make sense for mass clinics, planners didn't seem to factor in the needs of family physicians.

"This kind of packaging makes it much harder to deliver vaccine efficiently," said McGeer, head of infection control at Toronto's Mount Sinai Hospital. "We clearly did not think carefully enough about how to make the whole vaccine delivery system work."

Canada bought the vaccine and the adjuvant unmixed with the idea that unused adjuvant can be saved for future use, McGeer said.

From a cost-efficiency point of view, that makes sense. But from a time-efficiency point of view, having to mix the two at time of delivery will definitely lengthen wait times.

"It is more difficult and slower than with usual vaccines," she said. "Many family docs simply do not have the capacity to use this vaccine."

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

http://ca.news.yahoo.com/s/capress/...vaccine_studies

One dose? Two doses? What's right for kids when it comes to H1N1 vaccine?

Mon Nov 2, 8:47 PM

By Helen Branswell, Medical Reporter, The Canadian Press

TORONTO - It looks like American children will have to endure two shots or nasal squirts of H1N1 vaccine but the question of how many doses of vaccine Canadian kids will need remains to be answered, experts say.


The U.S. National Institutes of Allergy and Infectious Diseases (NIAID) released clinical trial data Monday showing that children under 10 didn't respond well enough to one dose of adjuvant-free H1N1 vaccine to consider them protected against the virus. Based on those data, the U.S. is sticking to its earlier recommendation that children under 10 get two doses of H1N1 vaccine, given at least 21 days apart.


But the World Health Organization is recommending countries focus efforts on giving as many kids as possible a single dose, given the current scarcity of supply. And Canada is holding out for more data.


The various positions may be a formula for confusion among parents. In anticipation that there are lots of questions, here are some answers:


Q: How many doses of vaccine will Canadian kids need?


A: That's not clear yet. Canadian kids (and adults) will have access to vaccine with an adjuvant, an additive that boosts the immune response induced by vaccine.


And a very small study by Canada's vaccine manufacturer, GlaxoSmithKline, suggests even kids as young as six months may be able to get away with a single dose of adjuvanted vaccine. A kid's dose is half an adult dose, with half the adjuvant an adult would receive.


Based on GSK's early data, Canadian officials say it's possible kids in Canada will only need one dose, but they want more information before making that decision.


But given that there must be a 21-day interval between the doses, there is still time to figure this out, experts say.


"For me, given the level of activity, the second wave activity already occurring, our goal should be ... get a first dose into kids. Then we can discuss the second dose," said Dr. Danuta Skowronski, a flu expert with the British Columbia Centre for Disease Control.


"We still have time to work out whether that second dose will be necessary."


Q: Why are U.S. officials saying kids under 10 need two doses?


A: U.S. pandemic planners decided against using adjuvant in their vaccine. And vaccine without adjuvant doesn't induce a terrific immune response in little kids, whose immune systems are still developing and who haven't had as much exposure to flu viruses as older children and adults.


The study results released Monday were based on a trial in 583 children aged six months to nine years of age who were given two doses of H1N1 vaccine without adjuvant at a 21-day interval.


The response to one dose was poor in children six months to 35 months - only 25 per cent reached the protective mark. In children three to nine years, the rate was 55 per cent, still too low by regulatory standards.


But Dr. Anthony Fauci, head of the NIAID, said after the second dose 100 per cent of the younger children and 94 per cent of the older children had antibody levels that suggest they are protected against the virus.


Q: Do those findings have any bearing in Canada?

A: Only if parents are planning to hold out for adjuvant-free vaccine for their kids.

A spokesperson for the Public Health Agency of Canada noted that parents who want to go that route need to realize kids will need two adult-sized shots of vaccine, given 21 days apart. And the full protection of those shots will only really be in effect two or three weeks after the second shot is give.

Q: But if I still want adjuvant-free vaccine for my child, will it be available?

A: Technically yes. But getting it may be a challenge.

Under pressure from some pediatricians and parents, Canada bought 600,000 doses of unadjuvanted vaccine for kids under three years old. Those doses are still in the production pipeline.

After the GSK trial results came out showing one half-dose of adjuvanted vaccine induced a protective immune response in 100 per cent of kids six to 36 months old in the study, federal officials stopped talking about unadjuvanted vaccine for toddlers.

The official recommendation for that age group is adjuvanted vaccine. And while federal authorities will say, if pressed, that unadjuvanted vaccine is still an option for little kids, they don't volunteer the information easily.

And it is conceivable that local clinics will interpret the recommendation as an edict, not advice.

"My understanding is the only time there's an option is in pregnancy," said Dr. Joanne Langley, who is chair of the National Advisory Committee on Immunization - someone you'd think would know if there was still a plan to offer unadjuvanted vaccine to kids under three.

"I haven't seen it on any provincial guidance about what they're doing for their vaccine programs, that they would offer unadjuvanted."

Q: Is the adjuvanted vaccine safe for small children?

A: The public health agency thinks so. So does the World Health Organization. So do a number of influenza and vaccine experts.

"My concern is we are having intense second wave activity now. So for parents to be holding out for an unadjuvanted when we're facing intense activity now, they'll miss the boat in terms of protecting their kids," said Dr. Danuta Skowronski, a flu expert with the British Columbia Centre for Disease Control.

"Better the bird in the hand than two in the bush."

Langley, a pediatrician who specializes in infectious diseases, agrees.

"I think as a pediatrician, knowing these children are vulnerable, knowing that the likelihood of them having a strong and quick immune response ... is so much lower with an unadjuvanted preparation . . . I think the best choice in that circumstance is to go with an adjuvanted preparation."

Q: If the U.S. says two doses and Canada says it needs more evidence before deciding, why is the WHO recommending one dose for children under age 10?

A: The WHO's position mixes evidence with pragmatism. Many countries are using adjuvanted vaccine for children, and the evidence currently points to one dose being sufficient.

But the organization also knows there's no where near enough H1N1 vaccine in the world, and they think it makes more sense to offer as many kids as possible one shot rather than worrying about giving kids two.

Fauci, the head of the NIAID, said the WHO is basing its recommendation on a strategy for maximizing available vaccine, while the U.S. is basing its on scientific evidence.

"We would like to get children as fully protected as we possibly can. Obviously the optimal thing is to get the children who are within the group that requires two doses to get all of them two doses in time."

-

Follow Canadian Press Medical Writer Helen Branswell's flu updates on Twitter at CP-Branswell

__________________ 
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.

Roscoe and Miss Priss 

http://www.google.com/hostednews/ca...qHQFiM3q5sYUIjA

Flu dogma being rewritten by a strange virus no one pegged to trigger a pandemic
By Helen Branswell Medical Reporter (CP) – 1 day ago

TORONTO — The World Health Organization's top flu scientist often describes the virus he's studied for years as "humbling."

And Dr. Keiji Fukuda isn't alone in marvelling at the mercurial nature of influenza. Flu scientists repeat almost as a mantra that the only thing predictable about flu is its unpredictability.

Yet despite decades of evidence that influenza will repeatedly rewrite the rules, flu dogma emerges and takes hold. Scientists keen to sift patterns from chaos agree X is true about Y - until the virus sets them straight yet again.

In the late '60s it was held that pandemic viruses emerged in 11-year cycles, after the closely spaced 1957 Asian flu and 1968 Hong Kong flu outbreaks.

It used to be accepted that only H1, H2 and H3 viruses could infect humans. And then viruses from the H5, H7 and H9 subtypes jumped from birds to infect people. Wrong again.

Though the world is not quite seven months into this pandemic, a number of widely held assumptions about flu and pandemics seem destined for the redrawing board when the dust from this outbreak settles.

Here are some:

-Pandemic viruses emerge from Asia, the cradle of flu viruses.

Years of focus on H5N1 avian influenza viruses left experts convinced Asia was the birthplace of new flu viruses and would be the source of the next pandemic. Despite the fact that there's good evidence the 1918 Spanish flu virus may have emerged in Kansas, no one was looking to North America as ground zero for the first pandemic of the 21st century.

It's a valuable lesson, says Dr. Nancy Cox, who has been pushing for a number of years for more flu surveillance in Latin America.

"You can't take your eye off the other possible threats. You can't focus too much on one area of the world because influenza - a new virus - can emerge from anywhere," says Cox, head of the influenza division at the U.S. Centers for Disease Control.

-Pandemics are triggered by "antigenic shift."

Flu viruses evolve constantly via small mutations, a process called antigenic drift. But once in a blue moon an entirely new virus bursts out of nature, an event known as antigenic shift. Because most people are vulnerable to the new virus, it ignites a pandemic.

It used to be thought pandemics could only be started by a virus with a new hemagglutinin - the H number in the virus's name - or a virus with a hemagglutinin that hadn't spread recently among people, such as the H2N2 viruses that circulated from 1957 to 1968.

The current pandemic is caused by an H1N1 virus, which is startling because almost everyone alive has antibodies to H1 viruses. They've been circulating among people since 1918, except for a 20-year gap between 1957 and 1977.

So few scientists would have predicted a new H1 virus could cause a pandemic at this point in history.

Some, in fact, still question whether this outbreak is a pandemic, at least by the definition science currently applies. The retired head of virology for the U.S. Centers for Disease Control is one of the doubters.

"There's no precedence for this," says Dr. Walter Dowdle, who now works for the non-profit Task Force on Global Health, based at Emory University in Atlanta. "Nobody had really thought that . . . the virus would re-emerge with this much background immunity."

But Dowdle cautions about dismissing the potential of this virus just because it defies our assumptions.

"We're the ones that make the definitions. And if the virus doesn't behave according to the definitions, well, it's our fault, not the virus's fault. So I think we have to be very careful about forcing the viruses into our definition, which can only be made based on what we've seen in the past. Now we've seen something different. And so therefore we've got to go back and rethink this."

-Emerging pandemics can be extinguished with quick use of antiviral drugs.

Landmark modelling studies published in August 2005 suggested that with good surveillance, rapid response capacity and enough Tamiflu, a flu virus that was just starting to spread person-to-person could be snuffed out.

The late Dr. J.W. Lee, then director general of the WHO, committed the agency to try. Experts at the agency and elsewhere spent untold person-hours honing a plan for trying to stop a pandemic at source.

And while flu experts were watching the spread of H5N1 avian flu viruses from Asia, pigs got infected with some viruses that swapped genes and created the H1N1 virus we call swine flu. By the time we knew it was spreading, containment was out of the question.

"This cat was not only out of the bag, but this cat had nine litters before we realized what had happened," says Dr. Michael Osterholm, director of the University of Minnesota's Center for Infectious Diseases Research and Policy.

-We'd know it when we saw it.

Pandemics are rare. And before this one, only two had occurred in the era of virology. So what would a pandemic look like? Experts insisted it was a bit like pornography - we'd know it when we saw it.

And then a new virus of swine-avian-and-human genes started to spread. It wasn't from a new subtype (see above). And but for the fact it was spreading in the off season and causing severe illness in younger people, it might have been mistaken for plain old flu.

Confusion ensued.

-There would be little time between the spotting of an emerging pandemic virus and the declaration of a pandemic.

The WHO's pandemic alert scale goes from Phase 1 (no threat) to Phase 6 (pandemic). For years the world had been at Phase 3, which means a non-human virus (H5N1) posed a pandemic threat and was triggering occasional cases, but person-to-person transmission was rare and limited.

Most experts assumed when a pandemic virus started to take off, the world would race through Phases 4 and 5 to 6.

Within 10 days of the first announcement that human swine flu infections had been found, the WHO raised the alert level from 3 to 4 and then to 5.

And then the world waited.

The virus spread as expected. What wasn't anticipated was political resistance to the declaration of a pandemic caused by such a mild strain. The gap between Phase 5 and Phase 6 stretched for six weeks - not because of the virus, but because of political wrangling and perceived need to ease the world into the first pandemic in 41 years.

-A mutation at position 627 on the PB2 gene means trouble.

After years of study, flu scientists believe they've found a number of signature motifs in viruses that can predict characteristics like disease severity or transmissibility. One is a mutation at the 627 position on a gene called PB2.

For as far back as molecular biology can see, all flu viruses known to have spread among humans had the mutation. That has led flu scientists to peg it as essential to transmission in humans. But this virus doesn't have that mutation.

Flu virologists have been on the lookout for pandemic H1N1 viruses with this change, believing it would confer greater transmissibility and maybe greater severity of disease. But when it was found in a few cases in the Netherlands, there were no nightmare changes in the illness pattern.

-People would clamour for pandemic vaccine.

Much of the recent pandemic planning was done with H5N1 flu in mind. The virus is a monster in humans, killing around 60 per cent of those infected. Planners assumed people would be desperate for pandemic vaccine.

But until recently, it seemed H1N1 wouldn't scare many people into vaccine queues. Instead, polls showed a surprising number were more nervous about the vaccine than the virus.

And even after the recent death of 13-year-old Evan Frustaglio of Toronto received widespread attention, a Canadian Press Harris-Decima poll showed only 55 per cent of Canadians want this vaccine.

Meanwhile in Europe, response to vaccination efforts has been indifferent.

"It's funny because I would not have predicted us to be in this situation a year ago. Because it's a no-brainer that you'll get the vaccine out and you'll want to vaccinate as many people as possible," says Dr. Michael Gardam, of the Ontario Agency for Health Protection and Promotion.

-People would need two shots of vaccine to be protected against a pandemic virus.

The assumption was that a pandemic virus would be so new our immune systems wouldn't be able to protect us against it with just one shot. One jab would be needed to "prime" our immune systems and a second to "boost."

Those assumptions were based on the idea a pandemic virus would be a new virus subtype, foreign to our immune systems.

Clinical trials of H1N1 vaccine show most people respond to a single shot of vaccine as if it's a booster, not a primer.

-Vaccine would be ready in time to combat the second wave of infections.

Planners expected more time between the emergence of the virus and a proper first wave of activity. And they thought there would be enough time before the second wave to make and deploy vaccine.

This virus has followed a different timetable, with a rapid and heavy first wave in the spring, continued activity over the summer and an early start to the flu season in the fall.

In Canada, the first supplies of vaccine have arrived as activity is really taking off in many parts of the country. Public health officials are in a race with the virus, trying to get vaccine into people before they can catch the bug. But it takes about 10 days for an immune response to develop after vaccination and in some cases, the virus is winning the race.

"I think most of us were hoping that there was going to be a longer gap between the initial identification and even a first wave," says Dr. Allison McGeer, head of infection control at Toronto's Mount Sinai Hospital.

The head of the CDC has been surprisingly blunt in his assessment of the existing system's capacity to make pandemic vaccine in a timely way. "The technology we are using, although tried and true, is not well suited for pandemics," Dr. Tom Frieden has said.

-Hospitals would be crippled.

Pandemic planners thought hospitals would be overwhelmed. Emergency departments would be swamped. Overflow facilities might be needed. Surgeries would be cancelled.

No one knows what this winter has in store and that scenario could still materialize. Certainly after high profile cases like the Frustaglio death, emergency departments have reported heavy use.

But so far, hospitals haven't been overwhelmed - except intensive care units.

Severe cases of H1N1 are rare, but people who develop bad disease are profoundly ill. ICU staff have to take extraordinary measures to oxygenate the blood of these people because their embattled lungs cannot do the work for them.

ICUs in a number of hard hit places during the spring wave reported nearing the point of overflow. If they reach that point, experts say, death rates will rise and other hospital services will need to be rationed. But that hasn't been the case to date.

Follow Canadian Press Medical Writer Helen Branswell's flu updates on Twitter at CP-Branswell

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Roscoe and Miss Priss 

H1N1 vaccine, given to millions, no serious side-effects seen: WHO
Twenty countries have started to vaccinate against the pandemic virus and the initial picture suggests the vaccine is safe, officials say
Helen Branswell
THE CANADIAN PRESS
updated on Saturday, Nov. 07, 2009 9:25AM EST
http://www.theglobeandmail.com/news...article1352203/


Millions of doses of H1N1 vaccine have been given so far and no serious side-effects have been seen, the World Health Organization said Thursday.

Twenty countries have started to vaccinate against the pandemic virus and the initial picture suggests the vaccine is very safe, Dr. Keiji Fukuda, the global health agency's top flu expert, said in a news conference in Geneva.

“We now have good evidence, based on many people receiving the vaccines, that we have no picture of unusual side-effects emerging,” Dr. Fukuda said.

“And the side-effects which are expected – such as a painful injection or perhaps some swelling at the injection site – these are occurring at rates which are expected and usually seen with seasonal influenza vaccine. So the picture right now looks quite good in terms of the safety.”

Dr. Fukuda said rates of local reactions may actually be lower than what is seen with seasonal flu shots.

In a wide-ranging update on the H1N1 situation, Dr. Fukuda said the viruses still aren't changing much – something that bodes well for the effectiveness of the H1N1 vaccine. But he said as immunity to this H1N1 virus starts to rise in the global population, the WHO expects the virus will begin to mutate.

He warned that the public may be concluding that this virus is insignificant or mild, but said it's too soon to write off H1N1.

“At WHO, we remain quite concerned about the patterns we are seeing, particularly again because a sizable number of people do develop serious complications and death. And again, we are seeing most of these occur in people who are younger than 65 years, a picture which is different from seasonal influenza.”

The pandemic viruses remain susceptible to the antiviral drugs Tamiflu and Relenza, with only sporadic and isolated cases of resistance to Tamiflu, Dr. Fukuda said. To date none of the viruses have been found to be resistant to the less commonly used Relenza.

He said the WHO does not object to a decision by Norway to make flu antivirals temporarily available this winter on an over-the-counter basis, saying it was an “innovative and prudent” way to relieve strain on an overburdened health-care system.

Global flu surveillance shows pandemic H1N1 viruses are the dominant flu viruses around the world, said Fukuda, who serves as special adviser on pandemic influenza to WHO Director General Margaret Chan.

That's been the case in North America for a while; the pandemic virus makes up about 99 per cent of flu viruses that have been found and typed.

But there have been pockets of the world where seasonal flu viruses – especially the H3N2 virus family – have continued to circulate. East Asia has continued to see a fair proportion of these viruses, making experts skeptical the pandemic H1N1 will extinguish or replace this subtype.

It is thought the new virus is crowding out or replacing the family of seasonal H1N1 viruses, which are being dropped from future flu shot formulations. This phenomenon of viral replacement has been seen in previous pandemics.

Dr. Fukuda said recently it's been seen that even in East Asia the pandemic virus is taking over.

“As we head into the winter, even in that part of the world the pandemic virus is clearly becoming dominant, and so we are seeing it crowd out the H3N2 viruses, and these are really falling in terms of the overall proportion.”

He did not venture a prediction, though, as to whether the H3N2 viruses would disappear entirely.

This family of viruses has evolved significantly since decisions were made last February on what should be included in the Northern Hemisphere flu shot for this winter. As a consequence, it is feared that if there is H3N2 activity later in the winter, the seasonal shot may not offer good protection against the H3 viruses.

But Dr. Fukuda said it's impossible to know that from looking at the genetic blueprint of a virus. It has to be tested – and those tests have not yet been done. He pointed out, however, that it remains unclear how much seasonal flu activity there will be this winter.

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"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.