christian --

I agree with everything you've said, but the possibility of a dangerous mutation in some ways makes me wonder even more about getting an untested vaccine based on the current seed stock, since perhaps such a vaccine wouldn't even help against a more dangerous mutation.

I suppose these thoughts may be moot as, at least in the US, there's probably unlikely to be the option of getting even an untested vaccine any time soon.


MomCares

__________________ 

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

Don't anthropomorphize viruses. They hate that.

I would opt for testing the vaccine because as you point out so far new H1N1 is not as deadly as feared. (Still I would prefer to not get infected.)
The governments will have to make tough decisions about the pandemic vaccine and who will get it. If there is a tested vaccine next fall with limited supply I would like to see the young ones (up to 18/20?) vaccinated, persons with further risk factors, health care professionals. Whoelse? Difficult to say.

I do not have any idea whether pregnant women could be vaccinated.

Toronto hospital nursery shut to new admissions after swine flu exposure
By Helen Branswell – 2 hours ago
http://www.google.com/hostednews/ca...xMgcVY0vPBQgLbg


TORONTO — A Toronto hospital has closed one of its nurseries to new admissions after a number of babies were exposed to someone infected with swine flu.

The hospital's head of infection control, Dr. Allison McGeer, said none of the babies in the unit is showing signs of infection with the new flu virus.

For now, she said, Mount Sinai Hospital has decided against giving the infants the antiviral drug Tamiflu on a prophylactic or preventative basis.

"I think you can take from the fact that we're not recommending prophylaxis that we don't think that this exposure was significant enough to cause illness," McGeer told reporters at a hastily convened news conference Thursday.

"If we believed the babies were at significant risk, then we would be recommending prophylaxis. But there's a difference between some risk and no risk. The closure is about no risk."

McGeer said there were 15 or 16 infants in the Level 2 nursery when the person who later tested positive for the H1N1 virus was in the unit on Monday. Several infants have since been allowed to go home and there were 13 babies still in the nursery Thursday afternoon, she said.

The babies are being closely monitored, McGeer said.

The incubation period for the disease is thought to be similar to that of seasonal flu strains, which is four days. But to be on the safe side the hospital will be watching them for signs of flu until next Monday, said McGeer, who is an influenza expert.

She would not reveal if the person who potentially exposed the babies to the virus was a staff member, a parent or a visitor {which probably means it was a staff member}, but did say the individual didn't realize he or she was sick at the time.

The individual tested positive for the virus on Tuesday and called the hospital to inform officials of the potential exposure. McGeer said a decision to close the unit was taken immediately.

The Level 2 nursery is for newborns who need some medical care. But it is not a neonatal intensive care unit.

A similar situation occurred last week in Greensboro, N.C., where a respirologist who was coming down with H1N1 flu had been in a neonatal intensive care unit. Women's Hospital of Greensboro decided to give all 33 newborns preventative doses of oseltamivir or Tamiflu.

McGeer said, though, that there is little experience with the drug in such small children. Mount Sinai will treat the babies if any of them develop flu, but for the moment watching and waiting seems to be the best course of action, she suggested.

"We are monitoring very carefully for symptoms and we will be testing and treating with a very low threshold. But the joint decision has been that we don't think the exposure is high enough risk that the babies need prophylaxis."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

CDC says lung disease linked to obesity risk factor for swine flu
By THE CANADIAN PRESS – 1 day ago
http://www.google.com/hostednews/ca...NER-U4yMVXh6OFg


TORONTO — The U.S. Centers for Disease Control says chronic lung problems linked to obesity, not the obesity itself, appear to be raising some people's risk of suffering bad disease when they get infected with swine flu.

Reports that obesity is common among people who have died from the new flu virus have led some public health officials to wonder whether it should be added to the list of risk factors for severe disease from influenza infection.

But Dr. Anne Schuchat of the Atlanta-based agency says the CDC believes people who are extremely or morbidly obese also have chronic lung disease.

She says carrying around the extra weight can compromise the lungs, making people more vulnerable to the negative affects of influenza.

So Schuchat says obesity is not in itself a new risk factor for influenza, its an outward sign of the presence of a risk factor that is already known.

Figures released by the CDC and the Public Health Agency of Canada continue to show that children and young people are making up a far great proportion of those being hospitalized for swine flu than one would expect to see with seasonal flu.

In Canada, 17 years old is the median age for hospitalized cases with the new H1N1 virus. In the United States, the median age is 19. Senior citizens are the age group that normally winds up in hospital with seasonal flu infection.

The CDC says it is finding about three-quarters of Americans who have died from swine flu had other health conditions that may have made them less able to fight off the virus.

The Public Health Agency of Canada only has details of the health status of 19 of 21 deaths. (Quebec announced an additional death Friday after the report was written, its 12th and Canada's 22nd.)

Of those, 13 or 68 per cent had pre-existing health problems, the agency said in its weekly online influenza update, FluWatch. Those underlying conditions included lung disease, diabetes, heart disease and high blood pressure.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Canada virtually sure to roll out H1N1 vaccine this fall: Butler-Jones
By: Helen Branswell, THE CANADIAN PRESS
http://www.cftktv.com/news/14/950312


TORONTO - The decision about whether to undertake a mass vaccination of Canadians against swine flu has been all but taken, the country's chief public health officer said Thursday.

Dr. David Butler-Jones said given the behaviour of the new H1N1 virus and the risk it poses, there is little chance Canada wouldn't push ahead with a vaccination program in the fall.

"At this point I cannot imagine not immunizing, given the nature of this disease, its variability and its risk to people, both in terms of illness but also serious illness and death," Butler-Jones said in an interview with The Canadian Press.

"It is a new virus, so most of us have no or very little immunity against it. And so immunization is our best protection."

As of Wednesday the World Health Organization reported nearly 56,000 people around the world have had laboratory confirmed cases of swine flu and 238 people have died.

In Canada, more than 6,700 confirmed cases have been reported and 22 deaths have been linked to the disease. The most recent, announced Thursday by officials in Manitoba, was a child under 18 who was said to have had some medical conditions.

A number of countries have placed orders with flu vaccine manufacturers for swine flu vaccine, which will take several months to produce.

But some - like the United States, where memories of the 1976 swine flu incident are still strong - have said they may delay making a decision about whether to use the vaccine until closer to the time when products have been tested and approved by regulatory agencies.

In early 1976 a swine flu virus infected a number of recruits at Fort Dix, Md., and the world thought a pandemic was in the making. Vaccine was made and a mass vaccination program was begun in the U.S. But the program was halted because of a higher-than-normal rate of cases of Guillain Barre syndrome in people who had received the shots.

It has never been determined why there was an elevated rate of the paralytic condition - which normally revolves itself over time - in people who received the vaccine.

Butler-Jones said safety trials of the new H1N1 vaccine will have to be conducted. And Canada's vaccine regulator, a branch of Health Canada, will have to study data from the trials to make sure the vaccine is safe and induces an immune response.

"We need to be assured that it's safe and the benefits are there," he said. "It's one step at a time."

Canada was the first country in the world to sign a pandemic flu vaccine contract. In 2001 it entered into a 10-year agreement with Shire Biologics - later bought by ID Biomedical, which was later bought by vaccine giant GlaxoSmithKline - that required the manufacturer to be constantly ready to begin production of enough vaccine to protect every Canadian who wants to be vaccinated.

The contract guarantees Canada access to the first vaccine that will be produced at GSK's manufacturing facility in Ste-Foy, Que.

Having domestic capacity to produce pandemic vaccine has long been considered a key to ensuring access. Pandemic planners have recognized that if a pandemic began to cause severe disease and a crisis situation arose, countries with vaccine manufacturing facilities within their borders might refuse to allow vaccine to be exported until domestic needs had been met.

Butler-Jones said there are decisions still to be made, including whether the country ought to offer the vaccine to everyone and in what order groups like children, adults and seniors should be vaccinated.

For instance, it currently appears that people over the age of 60 are at less risk of catching the virus and perhaps of developing severe disease if they do. One option might be to forego vaccinating that group.

"There may be some questions about how far you go in the population to actually address this," Butler-Jones said, though he acknowledged all the information needed to make good decisions may not be available when those decisions need to be made.

"As we've been doing, I expect we will likely be hedging our bets," he said.

Canada, like the rest of the world, will be watching what happens in the Southern Hemisphere during its winter, he said.

Based on the pattern of disease being seen, a group of experts will advise the council of federal, provincial and territorial ministers of health on a priority schedule for vaccine administration. Those recommendations will be made in the early fall, Butler-Jones said.

He said Canada is on target to start vaccinating against swine flu in late October.

-

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Canada-U.S. may go different routes on pandemic vaccine production
By Helen Branswell
http://www.google.com/hostednews/ca...xpav5Mn4ssTx5dw


TORONTO — Canada and the United States may go separate ways when deciding whether powerful boosting compounds called adjuvants should be added to swine flu vaccines, experts suggest.

Canada will likely use adjuvanted swine flu vaccine, says Dr. David Butler-Jones, head of the Public Health Agency of Canada.

But it is not a slam-dunk that regulatory authorities south of the border will clear adjuvanted flu vaccines for a U.S. mass vaccination campaign - if one takes place - this fall, some American experts say.

"The risk-benefit of using an adjuvant in a population in which you don't have a lot of data, i.e. younger people . . . has to be balanced against ... what's going on," says Dr. Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases.

"What's going on in our summer here? In the Southern Hemisphere's winter there? All of those things are going to be playing into the decision of what you're going to use or not use."

Ultimately decisions on whether to license pandemic vaccines with adjuvants will be the job of each country's regulatory agency - Health Canada here and the Food and Drug Administration in the U.S.

They and sister agencies elsewhere will face tough decisions in the weeks ahead, decisions that will likely have to be made with less data than such bodies typically require for the licensure of new vaccines or drugs.

Vaccine expert Dr. John Treanor suspects the FDA may be tempted to take the cautious route, opting to use vaccine without adjuvants.

"I think if you're risk averse, which many government agencies are, you might want to think ... 'Why throw this new thing in the mix that only has the potential to cause problems and create all these headaches for ourselves? Let's do something simple,"' says Treanor, an infectious diseases expert at the University of Rochester in western New York.

"The problem with the adjuvants is it just puts (in) that whole other level of complexity."

Adjuvants are compounds that ramp up the response the immune system generates to a vaccine. At a time when the goal is to vaccinate as many people as possible in the shortest possible time frame, these powerful tools hold a lot of appeal.

Punching up a vaccine's impact means you need less to protect each person. If, for instance, the amount of antigen - the stuff in vaccine that elicits the immune response - could be cut in half, manufacturers could fill orders quicker and stretch available supplies.

The World Health Organization has urged vaccine manufacturers to use what are called "antigen sparing strategies."

It hopes if countries that have pre-purchased pandemic vaccine use dose-sparing approaches, that will free up vaccine for countries that could not afford those kinds of contracts. Canada, the U.S., Britain, Switzerland and Australia are among those that have already purchased pandemic vaccine.

Butler-Jones says given the WHO's request and the fact that Canada's vaccine contractor, GlaxoSmithKline, wants to sell an adjuvanted product, Canada is likely to go that route - as long as the regulatory body is persuaded it is safe.

But adding a new component, such as an adjuvant, adds a significant wrinkle to a regulatory process that has been streamlined to accommodate the frequent strain changes needed to make flu vaccine, others warn.

Because influenza viruses mutate constantly, flu vaccines have to be reformulated regularly - almost on an annual basis. Regulatory agencies have devised a fast-tracking system that allows manufacturers to switch out strains and replace them with new ones as needed, without requiring new licences.

A pandemic vaccine made the same way seasonal flu vaccine is made could piggyback off that system, regulatory agencies have decreed.

But neither Canada nor the U.S. has licensed flu vaccines containing adjuvants. So adding one would erect regulatory hurdles that would either require additional clinical trials - prolonging time to vaccine delivery - or a decision to use the product under "emergency use" authorizations.

"It (adjuvant) makes it a brand new vaccine," Fauci says.

He notes the FDA would have to decide whether it was satisfied by safety data generated in Europe, where one manufacturer, Novartis, has an adjuvanted flu vaccine licensed for use in seniors. "The FDA's going to have to look at it and say: Does this extrapolate to teenagers or people in their 20s or 30s?"

Looming over those decisions will be the long shadow of the 1976 swine flu incident.

An outbreak of swine flu among army recruits at Fort Dix, Md., that year convinced officials they were watching the emergence of a pandemic. Vaccine was made and a mass vaccination program was undertaken in the United States, with 40 million people immunized.

The program was terminated when it was found that a higher-than-expected rate of Guillain Barre syndrome was occurring among vaccinated people. The paralytic condition, which is generally temporary, was recorded in more than 500 people who got the vaccine. And 32 people died.

It is still not known why that swine flu vaccine seemed to trigger such a high number of GBS cases. But as authorities contemplate another mass vaccination to protect against another swine flu virus, they are also wondering what adjuvant might do to the risk of a repeat.

One thought is that adjuvant might reduce the risk, by allowing for smaller doses of vaccine. But if the condition resulted from an immune system response to the vaccine, using adjuvant might elevate the risk.

"The point is ... you can argue the theories in either direction. That's all part of the considerations," Butler-Jones says.

Regulatory bodies are supposed to study evidence and make decisions based on what is best - safest - for their own country's citizens. Still, the special nature of a flu pandemic may add a complicating global equity aspect to the deliberations.

A country that opts not to use adjuvants will need more vaccine per person, leaving less for other countries.

Treanor acknowledges that erring on the side of caution could open the U.S. up to complaints: "Those greedy Americans used it all up because they were too afraid to use adjuvants."

"That's another consideration," he says. "Absolutely."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Swine flu virus may be here to stay
Fri, July 3, 2009
HELEN BRANSWELL, THE CANADIAN PRESS
http://lfpress.ca/newsstand/Today/2...011281-sun.html


TORONTO -- Swine flu viruses are missing at least two key features seen in all viruses that transmit well among people and yet the viruses are spreading efficiently, two new studies suggest.

The research groups that produced the work differ slightly in their views of the degree to which the H1N1 virus is spreading, with one finding transmission isn't yet as efficient as with human flu viruses while the other finding transmission rates are in lockstep with seasonal flu cousins.

There is no disputing the evidence, though -- the virus is spreading around the globe, killing at least 332 lives so far. And it is doing this without all the tools scientists would expect a flu virus may need to become a successful human pathogen.

"The take-home message is that a virus that does not have some of the features that we have previously recognized as hallmarks of adaptation of flu in humans was able to establish itself in humans and cause disease," said Dr. Daniel Perez, a virologist with the University of Maryland.

"Regardless of what the virus might do, I believe it is here to stay either as a whole virus or with some of its gene. It may be able to outcompete and/or co-circulate with seasonal flu strains."

Perez was not involved in the studies, both of which will be published today in the journal Science. He is, however, familiar with the work: His lab has completed a similar study.

The transmission studies were done by research groups at the U.S. Centers for Disease Control with colleagues from the Massachusetts Institute of Technology and at Erasmus Medical Center in Rotterdam, the Netherlands.

Both groups tested spread in ferrets, which are considered an excellent model for flu infection in humans.

The CDC's work suggests the virus isn't yet completely adapted to spread among humans. When healthy ferrets were housed in cages adjacent to and sharing feeding dishes with experimentally infected animals, only two-thirds of the healthy animals became infected in the CDC research.

By contrast, the group in the Netherlands found all healthy ferrets caught the new virus when housed next to animals infected with the virus. Perez's work also saw this 100% transmission rate.

In both the CDC and Erasmus studies, ferrets that were infected with human flu viruses transmitted infection to all their healthy neighbours.

Dr. Terrence Tumpey, senior author of the CDC study, said variation in the air flow between the CDC's ferret cages and those used in the other studies may explain the differing findings.

But based on what they saw, his team believes this virus may still be getting used to its new human host.

A key piece of evidence supporting their conclusion relates to the virus's ability to infect cells in the human respiratory tract. The CDC-MIT scientists showed the novel H1N1 virus's hemagglutinin -- the surface protein that locks onto a cell it's about to invade -- currently makes a connection that is weaker or less efficient than that made by regular flu viruses.

That suggests the virus has room for improvement. And if it mutates to bind more efficiently, it would become even more adept at spreading from person to person.

"I mean, it's transmitting. But we think it could potentially transmit even better," Tumpey said from Atlanta.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Tamiflu resistant H1N1 from Hong Kong more worrying than earlier findings
By Helen Branswell – 4 hours ago
http://www.google.com/hostednews/ca...1l0V3UoN6Q7mYOA


TORONTO — All cases of Tamiflu resistance are not created equal. So while the first three instances of swine flu infection with Tamiflu-resistant viruses were reported in the past week, it was Number 3, not Number 1 that put influenza experts on edge.

Public health authorities in Hong Kong announced Friday they have found a case of Tamiflu resistance in a woman who hadn't taken the drug. That means she was infected with swine flu viruses that were already resistant to Tamiflu, the main weapon in most countries' and companies' pandemic drug arsenals.

The two earlier cases, reported from Denmark and Japan, involved people who had been taking the medication. While always unwelcome, that type of resistance is known to occur with seasonal strains and may be less of a threat to the long-term viability of this key flu drug.

"It was not at all surprising to see resistance in patients on treatment but seeing it in someone who was not treated, it certainly is more concerning," says Dr. Malik Peiris, a flu expert at the University of Hong Kong.

There is currently no evidence Tamiflu-resistant viruses are spreading widely. Still, some experts see the Hong Kong case as a warning Tamiflu's role in this pandemic may not be as long-lived as pandemic planners would like.

"I think it's too early to judge," says Dr. Frederick Hayden, an expert on influenza antivirals who teaches at the University of Virginia. "But I think that possibility has existed from the beginning."

"And it's something that needs to be certainly considered in making determinations about things like antiviral stockpiling, management of patients with more serious illness in hospital and how the available drugs will be used."

Some experts say this early sign of resistance should prompt a rethink of how often and in which circumstances Tamiflu is used to battle the novel H1N1 virus.

"It ... probably highlights the importance of not using these antiviral drugs indiscriminately, given that the disease is relatively mild," says Peiris, whose hospital monitored the woman who was found to be carrying the resistant virus.

"In people who don't have underlying risk factors, it probably should not be treated with Tamiflu, basically."

Others suggest countries should limit how often they use the drug to prevent infection, a regimen known as prophylaxis. In prophylaxis, people who've been exposed to the virus are given one pill a day for 10 days, compared to the treatment regime of two pills a day for five days.

Some countries, including Canada, have been reserving prophylaxis for people at high risk from this flu, such as pregnant women.

But others have taken a different approach, using Tamiflu to try to curb spread of the virus. For instance, Britain has made the drug widely available to contacts of confirmed cases, though it announced this past week it was changing that policy.

The World Health Organization is drafting guidance for countries on the use of antivirals. While the WHO advises rather than instructs, it has been stressing that saving these drugs for treatment makes the most sense, says Dr. Keiji Fukuda, the agency's top flu expert.

"In general we have been pushing the advice that using these drugs for treatment is definitely the priority use of them," says Fukuda, the acting assistant director general for health security and environment.

"And I think this is not just from a theoretical resistance perspective, but also from the fact that if you have limited amounts of antiviral drugs, then you need to make some choices about how you use them."

From their first sighting, the new H1N1 viruses have been resistant to two older flu drugs, amantadine and rimantadine. That left the only two other influenza drugs, oseltamivir (Tamiflu) and zanamivir (Relenza), as the sole options for treatment and prophylaxis.

There is a risk inherent in using the drug to prevent illness. If people who are already infected but aren't yet experiencing symptoms are put on prophylaxis, there won't be enough drug in their systems to kill all the viruses they house. Those that survive develop resistance to the drug.

And that, it appears, may be what happened in the resistance cases in Denmark and Japan. In both instances the women involved had been given Tamiflu prophylaxis after a contact developed swine flu.

But the Hong Kong case was different. A 16-year old girl travelling from San Francisco was stopped in Hong Kong's airport in mid-June after setting off a fever detection device.

She was taken to hospital where she tested positive for swine flu. She had not been taking antivirals and declined to be treated with the drug. She was kept in isolation until she recovered.

Dr. Jennifer McKimm-Breschkin, an influenza expert from Australia and a member of the team that developed Relenza, says this case shows resistant swine flu viruses can spread.

It was previously thought flu viruses that developed resistance to the drug would be crippled in the process and would not transmit to others. But that belief was shattered in 2008 when it was discovered Tamiflu-resistant versions of the seasonal H1N1 viruses were spreading rapidly around the globe. They have since all but wiped out Tamiflu-susceptible seasonal H1N1 viruses.

"This is a patient that hasn't been treated, who has gone from San Francisco to Hong Kong. What that means is that she has caught a resistant virus in San Francisco," says McKimm-Breschkin, virology project leader at the Commonwealth Science and Research Organization - known as CSIRO - in Melbourne. (McKimm-Breschkin does not receive royalties for sales of Relenza.)

"So that means this virus has been transmitted from somebody who's presumably been treated. Which means it's been fit enough to transmit. And that is of a lot more concern than just resistance in a treated patient."

Experts have worried the seasonal H1N1 viruses might reassort or swap genes with the swine H1N1. If swine flu picked up with neuraminidase gene - the N in a flu virus' name - from the seasonal H1N1, it would acquire the resistance its seasonal cousin has developed.

Authorities in Hong Kong have not yet told the WHO whether that {reassortment} is what has happened in this case.

But whether the Hong Kong resistance case is due to reassortment, or from the fact that some swine flu viruses have developed resistance on their own, the situation demands careful monitoring, Fukuda and others say.

"The really big question for any finding of antiviral drug resistance with these viruses is whether it's an isolated event or whether it's a tip of a larger phenomenon," he explains.

"The bottom line, as is so often the bottom line with influenza, is that the real answer to the current situation is monitoring as closely as possible - which in this instance is really being done since an extraordinary number of viruses are being collected and looked at."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

So now we have a case originating in San Francisco and Hong Kong, a cities where alot of travel occurs. Also the possiblity of one in India. Not good news, but not unexpected. The Indian was tx and positive after 10 course of Tamiflu and allowed to go home (oops) in home isolation. At least India is not quite as mobile but I bet incountry transmission can be real high and testing might not be vigorous.

For more discussion on tamiflu resistance:

http://www.curevents.com/vb/showthr...9472#post949472

__________________ 
.
.

Roscoe and Miss Priss

Reality bites...

Swine flu vaccine production hits a snag: yield so far is 'less than optimal'
By Helen Branswell – 1 hour ago
http://www.google.com/hostednews/ca...v_1ZIxwdlZOqJuQ


TORONTO — Swine flu vaccine production has hit a snag, with manufacturers reporting a disappointingly low yield when vaccines viruses are grown in eggs.

The World Health Organization says so far the yield for egg-based production is half or less what manufacturers get when they make vaccine to protect against seasonal H1N1 viruses. The lion's share of influenza vaccine is made by companies that grow the viruses in eggs.

New seed strains are being made in the hopes of increasing the vaccine yield, a report by the WHO's vaccine chief, Dr. Marie-Paule Kieny says.

But if the yield cannot be increased, it will slow the rate at which pandemic vaccine comes out of the production pipeline, adding to the time it takes to protect populations in countries like Canada that have purchased vaccine. And countries that haven't pre-ordered pandemic vaccine would face substantial delays before manufacturers have product to sell to them.

"There's nothing to suggest it will take longer to make vaccine, if in fact everything goes as planned. The question is: How much?" says Dr. Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.

"There is nothing magical about making this virus. The questions will be: How much? When? and Where will it be available?"

The yield problem is revealed in presentations WHO staff made to last week's special meeting of the expert panel that advises the Geneva-based global health agency on vaccine issues.

The body - called the strategic advisory group of experts on immunization or the SAGE - was convened to give WHO counsel on a variety of questions about pandemic vaccine use. Those include which groups should be given priority when vaccine becomes available and whether the WHO should recommend companies use adjuvants, which are boosting compounds that could help stretch limited supplies.

Kieny, head of the WHO's initiative for vaccine research, was not available for interview Sunday. The WHO is expected to reveal details of the SAGE's deliberations and recommendations on Monday.

But a report to the meeting by Dr. Wenqing Zhang of the WHO's global influenza program says that vaccine manufacturers who use so-called wild-type viruses (unmodified viruses like those now circulating around the globe) are reporting yield rates similar to what they get when they grow seasonal H1N1 viruses in Vero cells, a cell culture medium. However, few manufacturers produce flu vaccine this way.

Most make vaccine in eggs, using a reassortant or hybrid seed strain designed to improve the chances of a good yield. These seed strains can be made by a couple of methods, but the end result is a hybrid with the external genes of the virus that vaccine is to protect against and the internal genes of a virus with a proven track record for growing well.

Zhang's presentation says that of the various reassortant vaccine viruses that have been made, the one with the highest output still only generates about half of the yield seen with seasonal H1N1 vaccine production.

Kieny's presentation calls the yield "less than optimal" and says laboratories in the WHO's lab network are generating new sets of vaccine viruses as quickly as possible.

Her presentation illustrates the impact low yield would have on availability of vaccine.

Somewhere between 850-900 million and 1.8 billion doses of pandemic vaccine are already spoken for, she reports. The low end of the scale represents what would be needed by countries with contracts if it is shown that one shot will be enough to protect a person; the high end represents what those countries would need if two shots per person are required.

If all manufacturers used the lowest possible effective dose, if yields are on a par with seasonal H1N1 production and if countries only used one dose per person, manufacturers could fill all their advantage purchase orders by mid-November, Kieny's presentation suggests.

That best-case scenario also requires that all manufacturing capacity remains devoted to pandemic vaccine and no portion shifts back to the production of seasonal vaccine for next year's Southern Hemisphere flu season.

If companies don't use low doses and countries that have pre-purchased vaccine demand two shots for all their citizens, it could be mid-April before the vaccine manufacturers in high-income countries have free capacity to devote to making vaccine for middle-and-low income countries, Kieny's presentation estimates.

Ninety per cent of the world's flu vaccine production capacity is in the high-income countries that use seasonal flu vaccine.

A lower yielding vaccine "would considerably push back the timelines," the presentation warns.

Assuming the yield is half that of seasonal flu vaccine production, it would be mid-January before producers could fill all contracts if they use a single-shot, low-dose regime, Kieny estimates.

She suggests even with low-dose shots, a low-yield scenario would mean manufacturers would not be able to fill all their existing contracts until next June if the countries opt for two shots per person for all their citizens.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Legacy of 1976 swine flu outbreak led to Canada's pandemic vaccine contract
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...GnQ2XHa64Zs56CA


TORONTO — If the swine flu situation becomes more severe and countries start squabbling over scarce pandemic vaccine supplies, Canada will be sitting pretty.

This country is in what might be a unique - or at least rare - position globally, able to fill all its pandemic vaccine needs within its borders.

That is not just a happy coincidence. Planning that started in the early 1980s, when bruises inflicted during the 1976 swine flu scare were still sore, led visionary Canadian pandemic planners to the realization that the only way to be assured access to vaccine in a flu pandemic was to have it made within the country's borders.

"It was the foresight of many people that's allowed us to have something in place that few countries have," says Dr. David Butler-Jones, Canada's chief public health officer and head of the Public Health Agency of Canada.

Most of the world's supply of flu vaccine is made in Europe, where much of it is used. Manufacturing facilities are located in France, Germany, the Czech Republic, among other places. The U.S., Australia, Japan and China also have flu vaccine plants within their borders.

And Canada has one as well, a plant in Ste-Foy, Que., currently owned by GlaxoSmithKline. That plant, expanded in recent years with federal government funding, is able to pump out 14 million vials of vaccine a month, and produce more bulk vaccine as well.

But in 1976, when 500 army recruits at Fort Dix, Md., fell ill with influenza caused by a swine flu virus, this country was in the position of having to purchase flu vaccine from the United States.

When then-U.S. president Gerald Ford famously declared the U.S. would vaccinate every man, woman and child against the new virus, Canada put in an order for swine flu vaccine and waited for its delivery.

It never came.

Dr. Susan Tamblyn, who has been a fixture in Canadian pandemic planning since the beginning, said in a 2005 interview with The Canadian Press that failure to secure vaccine made early pandemic planners realize the importance of security of supply.

Tamblyn is now a consultant for the Public Health Agency and declined to be re-interviewed on the subject. But in the earlier interview about the origins of the pandemic plan, she said no reason was ever given for why the order was not filled.

"I just know we couldn't get our vaccine. I don't understand exactly why. And we never really got to the bottom of that - whether it was a government decision or a company decision because they were supposed to sell everything to government. That I don't know," Tamblyn said.

"That's what triggered the move to security of supply.... Security of supply was a real sore point to us."

In 2001, Canada signed a pandemic vaccine contract with Shire Biologics, which then owned the Ste-Foy plant and a related facility in Laval, Que. Shire later sold to ID Biomedical, which then sold to GSK.

The contract, which has transferred with the ownership of the facilities, requires the holder to be at the ready to make pandemic vaccine for Canada at all times. That means having an available supply of hens' eggs year round to make vaccine, if it is needed.

The 10-year contract gives Canada first access to the vaccine produced at the plant. And it required the owners to upgrade the facilities, which were initially too small to meet Canada's pandemic needs.

All the while, the issue of security of supply was on the minds of those working on the pandemic plan and the vaccine contract.

"One of the considerations when we decided to proceed with having a domestic supply in Canada in 2001, and why we put a domestic contract in place was certainly concern related to border closures in the event of a pandemic. So that we had a secure supply in the country," says Dr. Arlene King, formerly the point person for the Public Health Agency of Canada's pandemic preparedness efforts.

King, who last month became Ontario's chief medical officer of health, was not with Health Canada when Tamblyn and a small coterie of other people started grappling with what it would take to get the country through the next flu pandemic.

Those early pandemic planners included: Dr. John Spika, recently returned to the Public Health Agency after a stint with the World Health Organization; Dr. Greg Hammond, who later went on to lead Manitoba's public health branch; and the late Dr. John Waters, who served as Alberta's provincial health officer.

"There's a number of people like that who I think have been real champions (of pandemic preparedness) long before I picked up the banner when I started my public health career," King says.

Work accelerated in 1997, when the H5N1 avian flu virus infected 18 people in Hong Kong, killing six and igniting fears a pandemic might be starting. In late 2003 when H5N1 re-emerged in Asia, the work took on new urgency.

As a result of all this work, Canada had the first national pandemic plan and the first pandemic vaccine contract. And when GSK's production line starts pumping out pandemic vaccine, the plant will be producing more than what Canada needs.

The excess vaccine - the vaccine the GSK facility cannot bottle in Ste-Foy - will be exported in bulk form to the U.S. and Europe for customers elsewhere, Butler-Jones says.

Would Canada close its borders and refuse to allow vaccine out of the country?

"No. I can't imagine that at all," he says. "A, it's not in anybody's interest. B, we've been fortunate with the planning and work to ensure that in a timely way we will have vaccine for Canadians."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Studies aim to answer key questions as world readies for swine flu vaccination
By Helen Branswell (CP) – 7 hours ago
http://www.google.com/hostednews/ca...a14Uko8sI-CF8IA


TORONTO — A flurry of innovative vaccine trials is in the offing as governments and regulatory agencies prepare for the probable launch of mass swine flu vaccination programs in the fall.

The results of the trials could determine whether people with egg allergies can be offered pandemic (and regular) flu vaccine, whether pandemic and seasonal flu shots could be given at the same time and whether one company's vaccine can be given with another's adjuvant, a compound that boosts its potency.

Vaccine manufacturers are either unable or unlikely to undertake the complicated studies required to answer these questions. Governments will fund the work instead.

Infectious diseases expert Dr. Anthony Fauci says the goal here for organizations like the U.S. National Institute of Allergy and Infectious Diseases - which he heads - is to fill key knowledge gaps for vaccine regulators.

"What are they going to need that somebody else can't do?" Fauci explains.

Some of those priorities will be aired Thursday in Washington when the U.S. Food and Drug Administration's vaccine and related biological products advisory committee meets in a session on clinical trials for pandemic vaccines.

Vaccine manufacturers will do the basic testing, work designed to assure regulators and would-be recipients that their vaccine is safe and likely to protect against the pandemic strain, an H1N1 virus of swine origin.

But there are many other key questions. In fact, the list is too long to tackle in its entirety in the limited time available.

So discussions between planners and regulators over the past few weeks have led to a paring down of priorities. In the case of the U.S., it's not yet clear which studies have survived the cut.

However, Fauci says his institute will green-light one looking at whether the pandemic vaccine - to protect against the new H1N1 virus - could be given at the same time as seasonal flu vaccine, which protects against three types of flu viruses including a different H1N1.

Co-administration, as it is called, would make the logistics of pandemic vaccine delivery much easier - if the pandemic vaccine is ready in time. But would giving people vaccines that protect against two different H1N1 viruses at once actually undermine the effort by weakening the response to one or both?

"As an immunologist, I don't think you're going to have any trouble with that. But you don't know," Fauci explains.

"Would presenting two different H1N1 antigens to the body at the same time result in antigenic competition? On the other hand, we could be surprised and giving them together might enhance the response to both."

In Canada, plans are underway to try to test whether people with egg allergies could be given flu shots containing vaccine produced in eggs. Currently that is considered unsafe and is not done.

With some manufacturers moving to grow their vaccine viruses in cell culture, that may be less of a problem in the future. But for now egg-based production still generates the lion's share of of the global flu vaccine output. Canada's entire supply will be egg-based vaccine.

Dr. Scott Halperin, a vaccinologist from Dalhousie University in Halifax, says a newly formed, federally funded research network hopes to get ethics approval to test the assumption it is unsafe to give people with egg allergies flu shots.

The goal will be "to basically look at what is the real risk, and to immunize individuals under very carefully controlled (circumstances)," says Halperin, principal investigator of the Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network.

"That is a real concern," he says of the current position on people with egg allergies. "You can't leave a whole segment of the population without access to protection."

Another question regulators in the United States and possibly some other countries need answered relates to the use of adjuvant. Specifically, they'd like to know whether one of the powerful new adjuvants made by companies like GlaxoSmithKline and Novartis could be used with antigen (vaccine) made by a company that currently doesn't market adjuvants, such as Sanofi Pasteur.

This type of study - called "mix and match" by those involved in the planning - won't have an impact in Canada. GSK has the contract to provide all of Canada's pandemic vaccine and is producing adjuvanted pandemic flu shots.

And the findings may not be put into application in the U.S. either, if it is shown that swine flu vaccine on its own will produce an adequate immune response. U.S. officials have repeatedly hinted they may forgo use of adjuvant if it isn't needed to get the job done.

But the U.S. has planned for contingencies, buying bulk adjuvant in case there isn't enough vaccine and supplies need to be stretched. Having some evident for the FDA that mix and match would work means the backup plan could be activated if needed.

"Nobody's going to do that (trial) but us," Fauci says. "I can tell you that for sure."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

If the pandemic does not get much more severe than it is right now, I think I'll step to the back of the line, thank you very much. I think I'd rather SIP until more is known.

Especially since (from the vaccine development thread):

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Roscoe and Miss Priss

Mosaic --

Having developed apparently-permanent asthma after my prolonged bout with probable SF, I'd sure wish immunity on all my friends.

I can see where it would be a tough choice for those with qualms about vaccination.

From the sound of things, those of us in the US may never have the luxury of that choice if there's no vaccine to be had.


MomCares

__________________ 

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

Don't anthropomorphize viruses. They hate that.

I'm very sorry about your asthma. Can not one hope for improvement, even if slow, for up to a year?

I have no problem with vaccinations and have had many kinds over the years. But this one is being rushed to market so fast, I do wonder if as much care as normal will be taken. I also no longer just trust anyone that says 'dont worry, it's perfectly safe.'

In actuality, if this gets more severe, I wont know what I would do if a vaccine were to become available and I was able to get it. I would need far more reliable information than is available now to stand in that line. In the end, as usual, we'll each have to make up our own minds.

__________________ 
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Roscoe and Miss Priss

Efforts to improve swine flu vaccine yields drawing a blank, experts warn
By Helen Branswell
http://www.google.com/hostednews/ca...PlMiPymuB854kew


TORONTO — It may take substantially longer to make the full amounts of swine flu vaccine countries have contracted to buy because efforts to improve the yield of the vaccine seed strains aren't bearing fruit, experts say.

Three of the laboratories involved in the work are sounding increasingly pessimistic that the yield problem can be fixed in the short term. Vaccine manufacturers have reported they are getting between 50 per cent and 75 per cent less vaccine with the new H1N1 virus as they do when they make seasonal flu vaccine.

"It's not looking very bright at the moment," John Wood, principal scientist at Britain's National Institute for Biological Standards and Control, said in an interview Tuesday.

"In effect, it means if we continue like this, manufacturers will have to keep on producing (pandemic) vaccine for longer to make the number of doses needed."

The flu laboratories at the U.S. Centers for Disease Control have made three new seed strains and are in the process of completing the paperwork needed to ship them to the manufacturers.

The head of the CDC's influenza division said while the new vaccine candidate viruses are growing well in the hands of her scientists, there's no guarantee they will produce a better yield when manufacturers start to work with them.

Dr. Nancy Cox said the issue isn't simply about growth, but also about how well the vaccine viruses hold up during the various steps of the manufacturing process.

"I think it is possible we won't have a better yielding virus," she admitted from Atlanta.

"(But) I think that it's still too early to say how this will impact the amount of vaccine that's available."

Each flu virus has its own characteristics and vaccine makers are accustomed to working with new strains, fine-tuning processes to try to coax maximum yield from a virus.

A spokesperson for vaccine giant Sanofi Pasteur said the company feels it hasn't yet exhausted efforts to improve the yield of the seed strain for the pandemic vaccine. Still, Len Lavenda suggested Sanofi doesn't expect those efforts to fully correct the problem.

"Although we think it's too soon to project what the final yield will be, we anticipate it will remain lower than seasonal vaccine yield," Lavenda said from Sanofi's headquarters in Swiftwater, Pa.

"Certainly if the yield doesn't increase it means it will take longer to produce the vaccine. (But) I think at this point in time we remain hopeful that we'll be able to increase the yield and think it's premature to throw in the towel, so to speak."

The various companies making pandemic vaccine have been working with a seed strain produced at New York Medical College in Valhalla, N.Y. Its laboratory pioneered the process of engineering vaccine viruses to maximize growth decades ago and scientists there have produced many of the vaccine seed strains used since.

Its first swine flu seed strain was overwhelmingly viewed as the best yielder by vaccine manufacturers. But even at that manufacturers said they got about half of the yield generated with seasonal flu production.

Doris Bucher, who heads the lab, says her team is trying other options, but they haven't seen anything promising yet. And she's heard manufacturers' efforts aren't paying off either.

"Usually they tweak it and it grows better. But it hasn't responded to tweaking. ... (That's) the feedback I'm getting."

Seed strains are hybrid viruses that have the surface genes of the virus the vaccine is meant to protect against merged with the internal genes of an old flu virus that is known to grow well in eggs.

Typically those hybrids - called reassortants - are made up of six genes from the high-growth virus with two genes from the target virus, which in this case is the new H1N1.

Seed strains can be made by two different processes. One, called the classical method, involves co-infecting growth medium with the two types of viruses and letting them swap genes on their own. The other involves a patented process called reverse genetics that essentially allows scientists to piece together the desired constellation of genes.

Bucher's first seed strain was made using the classical method, which means any vaccine made from it wouldn't require manufacturers to pay royalties for the seed strain.

But the new CDC-produced seed strains were made using reverse genetics. If manufacturers switch to use one of them, royalties for every dose of vaccine sold will be due to the U.S. vaccine company MedImmune, which holds the patent.

Bucher said her original seed strain was made with three genes from the swine flu virus and five from the high-growth virus. Her team is now trying to see if a six and two constellation would work better.

But she and others admitted the yield problem may be due to something inherent in the swine flu viruses.

"It possibly is," admitted Wood, whose lab also generated seed strains in the first round of production.

"This is unusual, having all the labs who usually do this work and there still being a less than satisfactory outcome. Usually, we get at least one virus which is good. Average to good. And this time none of them are."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Quebec finds first, Japan finds second cases of Tamiflu-resistant swine flu
By Helen Branswell (CP) – 10 hours ago
http://www.google.com/hostednews/ca...FnwA_JRXyesKjAQ


TORONTO — Canada has recorded a case of Tamiflu-resistant swine flu virus, in a Quebec man who had been given the drug to prevent infection.

Meanwhile, Japan revealed Tuesday it had found a second such case of Tamiflu resistance, in a person who has no ties to the country's earlier reported case.

The cases are the fourth and fifth globally since the new H1N1 virus was discovered in April.

The Quebec man, 60, was given the flu antiviral after his son fell ill with the pandemic virus. It's believed the resistance arose in the man and there is no evidence he transmitted resistant virus to anyone else.

"It appears to be an isolated case," said Jirina Vlk, spokesperson for the Public Health Agency of Canada.

"Although the strain does not appear to have spread beyond the reported individual case we continue to be vigilant on this front."

Use of Tamiflu to prevent infection - a procedure called prophylaxis - has been seen on occasion to give rise to resistant viruses.

"We know that it was going to happen and it's not good news that it's happening," said Dr. Allison McGeer, an influenza expert at Toronto's Mount Sinai Hospital.

But she said given the amount of Tamiflu being used in the world right now, such cases are bound to arise.

"It's the problem with influenza, right? Either we're going to see small numbers of these and they're just going to kind of appear periodically and we're all going to worry or it's going to go big," McGeer said.

"There's probably not going to be much in between."

Another such case cropped up in Japan, in the city of Yamaguchi. Japan's National Institute of Infectious Diseases logged genetic sequence data for the virus on Tuesday in Genbank, a repository for genetic sequences used by flu researchers.

The lab's director, Dr. Masato Tashiro, confirmed the case in an email containing details provided to the World Health Organization.

The new case was a person who had been given the antiviral drug as post-exposure prophylaxis - an attempt to prevent illness in a person exposed to the pandemic virus.

The person has since recovered, and it appears that there has been no spread, the email stated. The virus was sensitive to Relenza, a second drug in the same class as Tamiflu.

The earlier Japanese case had occurred in a person in the city of Osaka.

Other cases have been reported by Denmark and Hong Kong. Four of the five cases arose in people who had been taking the drug.

One, however, was recorded in a girl from San Francisco who travelled while sick to Hong Kong. Health inspectors at the airport there pulled her aside and tested her for swine flu.

She was positive, but told doctors there she hadn't taken Tamiflu. That suggests the virus that caused her infection was already resistant. U.S. officials have intensified surveillance for resistant viruses in the San Francisco area but say they have not found other cases.

The Public Health Agency says the Quebec man recovered from his bout of swine flu without complications and never needed hospitalization.

Vlk said the agency recommends using Tamiflu for treatment only, adding prudent use of the drug could stave off the development of resistance.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Ya learn something almost every day.

I wonder if two strains are relatively close, but one puts out a bit more than another, if they would choose the one that they would not have to pay royalties for.

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Roscoe and Miss Priss

Vaccine fast-tracking years in planning
Published Thursday July 30th, 2009
Regulators intend to treat pandemic vaccine as a supplement or amendment to existing flu vaccines licences
D2
By Helen Branswell
THE CANADIAN PRESS
http://timestranscript.canadaeast.c.../article/745183


TORONTO - As pharmaceutical companies rush to make H1N1 flu vaccine, regulators in Canada, the U.S. and Europe are flipping into gear plans they have honed over several years on fast-tracking flu vaccine for a pandemic.

The approaches are not identical, but are variations on a theme. Flu vaccines have been used safely for decades and this pandemic version is just one more flu vaccine, they say.

"Really, the same manufacturer will be making the same vaccine and it's just considered as a (strain) switch," explains Dr. Elwyn Griffiths, director general of the biologics and genetic therapies directorate, the section of Health Canada that regulates vaccines.

Though they work within the frameworks of different laws, Health Canada, the U.S. Food and Drug Administration and the European Medicines Agency (EMEA) all intend to treat the pandemic vaccine as a supplement or amendment to existing flu vaccines licences, either for seasonal or pandemic vaccine.

The goal is to try to speed approval of the vaccine so that it can be used before the pandemic is over -- if and when political or public health authorities decide vaccinating all or parts of the population is the right way to go.

"Remember, these are two separate decisions," says Dr. Norman Baylor, director of the FDA's office of vaccines research and review. Baylor uses his hands during a recent meeting in Gaithersburg, Md., to explain the demarcation between approving pandemic vaccine and ordering mass vaccination.

"The decision to deploy the vaccine, that's over here. The decision to license the vaccine, that's over here," he says, holding his hands out to opposite sides of his body.

The second "over here" is the realm of the regulatory agencies, which have been working with the World Health Organization and each other for years striking plans for how to respond to the special demands of a pandemic. The impetus was the dangerous H5N1 virus, which kills about 60 per cent of people infected. Obviously rapid action would be needed if it started a pandemic.

"The idea was 'How can we do it? How can we move forward?'" Griffiths explains.

The work led to "Regulatory Preparedness for Human Pandemic Influenza Vaccines," a set of guidelines crafted by the WHO's expert panel on biological standardization.

Governments and their vaccine regulators realized that if pandemic vaccines were treated like a brand new vaccine -- recently introduced products to protect against HPV or rotaviruses, for instance -- clinical trials involving tens of thousands of people would be needed.

The pandemic would be over before the pandemic flu shots would be injected into anyone but the volunteers in the clinical trials.

That approach is obviously impractical. And regulators believe it is also unnecessary for flu vaccines, which have been reformulated countless times to target new virus strains in the half century or so they've been in use.

Over that time, billions of flu shots have been administered. While people often complain of soreness at the site of the injection, serious side-effects from flu shots are extremely rare.

So how will regulators proceed now?

To understand Canada's approach, it's helpful to first look at what the EMEA has done.

It offered all flu vaccine manufacturers the chance to go through a special advance licensing process, producing a "core dossier" of safety and immunogenicity data on their manufacturing processes and their pandemic vaccines.

Three companies -- Baxter International, GlaxoSmithKline and Novartis -- went through the process, using H5N1 vaccines as their surrogate pandemic vaccines.

These "mock-up dossiers," as they are called, serve as the regulatory proof of safety and immunogenicity of any pandemic vaccine these manufacturers make. Manufacturers then apply for a "pandemic variation" to switch the subtype covered by the vaccine from H5 to the pandemic virus, in this case an H1N1.

"The whole concept of the mock-up vaccine relies on the fact that you can extrapolate to some extent the clinical efficacy data," explains Monika Benstetter, a press officer for the EMEA.

The agency says it can process a pandemic variation application in five working days, though it will still be up to national governments as to whether they want to use the fast-tracked vaccines.

Canada went through a similar process with this country's pandemic vaccine contractor, GSK, says Griffiths.

But whereas the EMEA actually licensed the pandemic vaccines, Canadian authorities held the approval in abeyance.

"They (Europe) have licensed 'the mock' if you like . . . and then all that was needed was a strain change," he explains. "We have come to the starting line, if I can put it that way, with the mock H5N1 and we did not license."

He insists the difference is a "nuance" that won't gum up the works in Canada. "We can use all those (mock up dossier) data, switch in the new strain and away you go."

But Griffith says Health Canada wants GSK to do a small trial -- involving 100 to 200 people, probably -- to generate some safety and immunogenicity data for the H1N1 vaccine before the pandemic vaccine can get approval. Like the EMEA, Health Canada can turn that application around in five days, he says.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Boosting compounds called adjuvants complicate licensing of pandemic vaccines
By Helen Branswell (CP)
http://www.google.com/hostednews/ca...Mphx3rTwz8rOEfQ


TORONTO — As swine flu vaccine becomes available in coming months, boosting compounds known as adjuvants may stretch out limited supplies. But they also pose special challenges for vaccine regulatory agencies in places like Canada and the United States.

Neither country has licensed flu vaccines with adjuvants in them before, making the addition of the oil-and-water emulsions a potential hurdle to plans to fast-track pandemic vaccines. Fast-tracking is based on the premise the vaccine is the same as seasonal flu shots, just targeting a different virus.

For that reason, officials in the U.S. have hinted they would rather not use adjuvants, unless the compounds are needed to ensure adequate supply for Americans. With manufacturers complaining of low yields as they attempt to make the new vaccine, that need remains a possibility, officials admit.

Canada will likely take a different approach. The head of the Public Health Agency of Canada, Dr. David Butler-Jones, has said Canada will use adjuvanted vaccine in response to a call from the World Health Organization to stretch the limited available global vaccine supplies.

Using adjuvanted vaccine also offers the benefit of faster delivery of enough vaccine to meet the country's needs. If adding an adjuvant allows a half dose or a third of a dose to be used per person, each batch of vaccine that rolls off the production line will protect more people.

Health Canada has been working with GlaxoSmithKline, the country's pandemic flu vaccine contractor, for several years on a process to fast-track pandemic vaccine.

That work, using an H5N1 vaccine as a surrogate, has given the regulatory agency access to data on the safety and effectiveness of GSK's adjuvant, AS03.

"We do have a lot of data which has been generated on the safety of the adjuvant with the H5 background," says Dr. Elwyn Griffiths, director general of Health Canada's biologics and genetic therapies directorate, which regulates vaccines.

Griffiths says Health Canada wants GSK to conduct a small study that would provide "minimum data on initial immunogenicity and some safety data if we're going for the adjuvanted vaccine."

If it is decided adjuvant must be added to get a good response from the vaccine or should be added to stretch out limited supplies, Griffiths says Health Canada would turn to a tool known as a notice of compliance, using interim orders under Canada's Food and Drugs Act.

"Because we can't have the big studies, you see? So we will go on the minimal data, which we would get from a much smaller study, which is being developed," he says.

In the U.S., the Food and Drug Administration will use a mechanism called an emergency use authorization or EUA if the U.S. administration decides adjuvants must be used there.

That decision, FDA officials signalled at a vaccine advisory committee meeting last week, will be a political one, not one that rests with the regulatory agency.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

That's OK, let the Aussies test it first.

Just kidding. We'll have some vaccine and we still have Tamiflu and Relenza. I think things are fairly well under control. But as for a mutation making the vaccine moot, I would expect partial immunity even if the virus does mutate.

That could be enough to prevent fatalities even if it didn't prevent infection.

My way of thinking too. If people over 65 still have some immunity from a previous pandemic, and if really old people still have some from as long ago as 1918 exposure, surely being exposed to something more recent, via innoculation or even having swine flu, would grant some immunity. You might get sick, but perhaps (without an underlying health condition) you wont die.

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Roscoe and Miss Priss

It all boils down to "risk assessment"; Pandemic driven fatalities v.s. potential adjuvant driven side effects and/or political fallout.

Certainly the WHO will want the largest possible output of Pandemic vaccine for the world population, regardless of possible side effects which the drug companies claim are minimal anyway. The problem with adding adjuvants to the Pandemic vaccine is that adjuvants are propriatary, differ by drug companies, and even where they have been tested and used with other vaccines, there has been little or no testing of the effect of each of these adjuvants on pregnant women, fetuses, and very young children, over time.

U.S. politicians remenber the 1976 Swine flu vaccine fiasco which left hundreds of people neurologically damaged, not to mention the ongoing debate about autisum and adjuvated vaccines for children. Adding a potentially poorly tested adjuvant to the Pandemic vaccine could create a generation of lawsuits, and create problems no politician would want to face.

My daugter is pregnant with twins. Her doctors have already given her Tamiflu to have on hand. Considering her job and other activities, the risk is great that she will be exposed to the H1N1 virus before delivery in December.

An adjuvanted Pandemic vaccine could be a risky choice for her and other pregnant women. Without adequate testing, there is no way of knowing what kind of danger any of the possible vaccine additives or adjuvants might pose to delicate developing fetuses.

justathought --

Best wishes to your daughter on an uneventful pregnancy resulting in two beautiful new babies!! I can't imagine giving birth to, or having, twins. I'll bet you're all very excited!!


MomCares

__________________ 

"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 50.4 million doses of pandemic vaccine; feds picking up 60% of cost
By Helen Branswell Medical Reporter (CP) – 15 hours ago
http://ow.ly/jjGU


TORONTO — Canada will purchase 50.4 million doses of pandemic flu vaccine, an amount that should be sufficient to protect all Canadians who want to be vaccinated against the swine flu virus, federal officials said Thursday.

The order was announced by Health Minister Leona Aglukkaq, who said the federal government would pick up 60 per cent of the $403.2 million tab for the vaccine.

"This investment reflects the unique circumstances of the situation as well as the gravity," said Aglukkaq, who called it a special one-time contribution. She noted that with seasonal flu vaccine purchases, provinces and territories are responsible for 100 per cent of the cost of their programs.

The vaccine will be bought from GlaxoSmithKline, which will make the product at its facility in Ste-Foy, Que.

Dr. David Butler-Jones, head of the Public Health Agency of Canada, said the size of the order should be sufficient to cover all Canadians who want and-or need pandemic vaccine.

"I think there's a fair degree of confidence that the amount that we've ordered will be sufficient," he said in an interview with The Canadian Press.

"Again, I'm waiting to see what the clinical trials show before being definitive."

That is a reference to the fact that it is not currently known whether one or two doses of vaccine will be needed to protect against the new H1N1 virus.

It is thought, though, that older adults - who seem less vulnerable to the virus - may be able to get by with only one dose. And Butler-Jones said because Canada is likely going to be using vaccine containing an adjuvant - a compound that boosts its potency - there is reason to believe one dose may suffice across all age groups.

He explained the federal math this way:

There are 33.6 million Canadians. The federal pandemic plan suggests authorities should bank on 75 per cent of Canadians wanting or needing vaccination. With 50.4 million doses, 75 per cent of Canadians could each get two doses.

But if only one dose is needed for some or all Canadians, different formulas could come into play.

The order size obviously allows for one dose for 100 per cent of Canadians, or one dose for all and a second dose for 50 per cent of the population, if studies show some people need two doses, Butler-Jones said.

Canada has the option of going back to request more vaccine if studies show two doses per person are needed and demand outstrips supply, Butler-Jones said. But he called that "a very, very unlikely situation."

Polling the government has commissioned suggests that at this point, only about 60 per cent of people might want pandemic vaccine. Only about a third of Canadians get a seasonal flu shot, Butler-Jones pointed out.

"We're ordering more," he said. "This is all hedging our bets to ensure that we err on the side of caution."

In fact, it is quite possible the country could find itself with excess pandemic vaccine on its hands, the chief public health officer admitted.

He said the government is talking with GSK about potentially turning back part of the order, if it becomes apparent Canada doesn't need 50.4 million doses.

"The most likely scenario is that we will end up with excess vaccine. So we'll be working closely with the manufacturer to make sure there are ways to ensure that that can get to other countries," Butler-Jones said.

Canada has first access to vaccine produced at the Ste-Foy plant, having signed the world's first pandemic flu vaccine contract in 2001 with Shire Biologics, a previous owner of the plant. GSK inherited the contract when it bought the facility in 2005.

GSK has indicated it wants to sell an adjuvanted vaccine and the World Health Organization has urged countries to use vaccine formulas that allow limited global supplies to be stretched as far as possible.

Canadian officials have repeatedly said they expect to start receiving supplies of the vaccine in late October or early November, by which time clinical trials already underway in other countries should inform decisions on the size and number of doses needed.

The WHO said Thursday that trials have started in China, Australia, Germany, the United States and Britain and more will start in the days to come.

The head of the agency's initiative on vaccine research, Dr. Marie-Paule Kieny said production of the pandemic vaccine is "on track" and some countries may start to administer vaccine as early as September.

Butler-Jones said Thursday that the public health agency expects Canadians who want vaccine will receive at least one dose before Christmas. If a second is required, those doses will likely be administered after Christmas, he said.

When two doses of a vaccine must be given, there has to be an interval between the doses. For this vaccine, it is expected the interval would be at least 21 days.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Thank you. After a miscarriage, they tried for six or seven years to have more. This was an In Vetro success. Both fetuses are growing well and are almost viable. I am not counting on anything though until I hold the babies.

About Baxter

It looks like the reason the U.S. has not contracted for any of those 80 million doses of Pandemic vaccine from Baxter is because they are a product of new cell based technology which has not yet been licensed by the U.S. Good News, actually.

Baxter's vaccines will be licensed in time, and the U.S. will have a dependable source of vaccines made in the U.S. Not a consideration in normal times, but could mean life and death in a Pandemic or Biological attack/accident.

About Flu-Mist

It sounds like they are making gallons of the stuff and the only slow down in production is having enough flu-mist dispensers. Apparently eyedroppers work, and in an emergency, I wonder if pints of flu-mist with eyedroppers might not show up at school, etc.

The Swine Flu

We have been very lucky so far. The Bird Flu scare got the world started on serious Pandemic preparations and improved vaccine technology, and the Swine flu is putting on the finishing touches.

In spite of problems with isolated genetic populations and looming Tamiflu resistance, if the Swine flu stays relatively mild, we will have dodged a bullet and will be in much better shape next time. I can't help but worry that a real killer is waiting in the wings. The 80% case fatality rate of H5N1 in Indonesia continues to be alarming....

Some flu viruses may set up sufferers to get Parkinson's later in life: study
By Helen Branswell Medical Reporter (CP) – 4 hours ago
http://www.google.com/hostednews/ca...1Yv102fGGMV0GHw


TORONTO — Infection with some kinds of influenza viruses may set up people to be at higher risk of developing Parkinson's disease later in life, a new American study suggests.

The work, inspired by the story behind the 1990 movie "Awakenings," suggests some aggressive strains of flu that can pass into the brain may deplete dopamine-creating neurons, leaving a person more vulnerable to developing the neurodegenerative disease at a later date.

"I am very confident (that) ... viruses will be considered a player in the etiology of PD (Parkinson's disease)," said senior author Dr. Richard Smeyne, a neurologist and neuroscientist at St. Jude Children's Research Hospital in Memphis, Tenn.

"Not a direct cause, but maybe the initiating cause... It sets you up."

"Awakenings" was the story of how American neurologist Oliver Sacks figured out he could revive people suffering from a strange sleeping sickness called encephalitis letharagica or von Economo's encephalopathy using the newly discovered Parkinson's drug L-dopa.

An epidemic of von Economo's encephalopathy in parts of Europe and in North America was recorded from about 1915 to 1926. A couple of decades later some of the survivors of the event descended into a catatonic state which Sacks correctly identified as Parkinsonian.

The overlap of the initial outbreak with the 1918 Spanish flu led some people to conclude infection with that virulent virus was the trigger for the illness.

Smeyne has been studying whether there is a viral component to the development of Parkinson's disease. Unusual clusters of cases have led researchers to believe exposures to environmental agents like pesticides or bacterial or viral infections may contribute to the development of Parkinson's in some people.

The most famous of the clusters involved a Vancouver TV show in the late 1970s on which a young Michael J. Fox worked. Fox and several other members of the production developed Parkinson's at an early age.

In discussions with colleagues in St. Jude's renown influenza research team, Smeyne and his team decided to look at whether influenza viruses might be one such trigger using another highly virulent flu virus - the H5N1 avian flu variety. A co-author of the paper is Dr. Robert Webster, a leading figure in the world of influenza.

The article, published in the Proceedings of the National Academy of Sciences, traced the entry and progression of the H5N1 avian flu virus in the brains of infected mice. The scientists found the aggressive H5N1 virus killed about 17 per cent of dopamine-creating neurons.

Smeyne said a corresponding loss in humans - if it occurs - wouldn't be enough to trigger Parkinson's on its own. But it could predispose a person to be more vulnerable to developing it, or speed up the point in life at which someone might develop the neurodegenerative disease, he said.

An expert on the virus that caused the Spanish flu, Dr. Jeffery Taubenberger, said the study raises an interesting hypothesis, but does not answer the question of whether flu viruses play a role in the development of Parkinson's.

"I think that it's certainly interesting to think about ... certain viruses that might be able to replicate in neuronal cells as an example of something that could lead to an insult, a physical insult, that could lead to some kind of neurodegeneration," said Taubenberger, an influenza researcher at the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

"But I think that it is a bit extreme to take a mouse study and then say that there might be a link in humans to Alzheimer's or Parkinson's disease."

Taubenberger, who led a team that excavated viral remnants of the virus that caused the Spanish flu and then sequenced the virus, said a sort of mythology has encompassed the 1918 virus, ascribing to it powers it probably did not have.

Work he has done looking at whether the virus was responsible for the epidemic of von Economo's encephalopathy does not support a link, he said. He and his team have studied preserved brain tissues of people who suffered from the condition, looking for traces of viral RNA. They found nothing.

They also looked at whether the 1918 virus travels into the brain when mice are experimentally infected with it. It does not. The combined work, Taubenberger said, led his team to conclude the data don't support a strong link between the 1918 flu and the outbreak of von Economo's encephalopathy.

He suggested a study of survivors of H5N1 infection could shed light on whether they suffer any neurological or neurodegenerative conditions that might be linked to that virus.

Smeyne said the neurodegenerative aspect his team sees with H5N1 probably does not exist for all flu viruses and may not be true for the milder swine flu or H1N1 virus causing the current flu pandemic.

"It's a fairly mild form of influenza. There doesn't seem to be encephalitis associated with it," he said.

"That would suggest we would not see it (crossing into the brain). But I think without the direct experimental evidence which we need to look at, I think that we can't say one way or the other at this point."

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Rich countries must share pandemic vaccine with the poor: Gates executive
(CP)
http://www.google.com/hostednews/ca...QXaltGhsFk9ybEQ


TORONTO — A top executive in the Gates Foundation has issued a stinging call to rich countries to share pandemic vaccine with developing countries.

Dr. Tadataka Yamada says it would be inexcusable to force poor countries to wait until citizens of rich nations have been vaccinated.

In a commentary in the New England Journal of Medicine, Yamada says manufacturers shouldn't follow the first-come, first-serve model of business when it comes to delivering pandemic vaccine, regardless of the fact that contracts have been signed.

Further, he says rich countries should help less affluent countries pay for the vaccine they need.

And he says countries with vaccine manufacturing plants within their borders must resist the temptation to put their citizens' needs first by nationalizing production.

Yamada says he cannot imagine standing by and watching if, at a time of crisis, the rich live and the poor die.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Singapore, China find Tamiflu-resistant H1N1 viruses: WHO
Aug 12, 2009 05:25 PM
Helen Branswell
THE CANADIAN PRESS
http://www.thestar.com/news/canada/article/680265


More cases of Tamiflu resistant swine flu viruses have come to light, the World Health Organization said today.

China and Singapore have found Tamiflu-resistant pandemic viruses, Charles Penn, a scientist with the Geneva-based agency, said in an interview with The Canadian Press.

He revealed that the WHO has also been alerted informally to the discovery of a small number of other Tamiflu-resistant viruses. He would not say where they were found or how many there were in total.

"It's a small number. It certainly doesn't change the scale of what we're seeing," Penn said.

The WHO has received formal notification of seven cases where people suffering from pandemic flu were found to be infected with viruses resistant to Tamiflu, one of only two flu drugs that work against these H1N1 viruses. Since the time of their emergence earlier this year, the pandemic viruses have been resistant to two older flu drugs, amantadine and rimantadine.

Japan has reported finding three cases of resistance. Canada, Denmark, Hong Kong and Singapore have each found one.

Chinese authorities haven't yet filed a formal report including information about their case but WHO was alerted to the initial laboratory finding through the Global Influenza Surveillance Network, Penn said. The case occurred Hunan province.

Formal notification involves reporting on details of the case, including whether the patient was taking Tamiflu for treatment of flu or prophylaxis (prevention).

The WHO also wants to know whether the virus has been checked to see if all the genes are those of the pandemic virus or whether the pandemic virus might have swapped genes with the seasonal H1N1 virus.

That would be an unwelcome turn of events: virtually all the human H1N1 viruses circulating over the past year or so have been resistant to Tamiflu. It's an attribute public health authorities would not like to see the pandemic virus acquire.

Penn said to date there is no evidence of that kind of gene swapping – called reassortment. Nor is there any sign that the resistant pandemic H1 viruses are spreading from person to person, he said.

"Basically what it looks like is they are all individual isolated cases. No onward transmission and no suggestion or implication of them having originated, if you like, from a common source," he said.

It has always been expected that some degree of resistance to the drug would arise. Studies done years ago by the drug's maker, Roche, found that in rare cases people taking the drug either for treatment or prevention develop resistance.

"It's been there all the time as an event which can happen with a low frequency. And therefore what we're seeing now is no more or less than we would have expected from those early data," Penn said.

It was long thought Tamiflu-resistant flu viruses would not spread and so didn't pose much of a threat. But in the winter of 2008, the explosive development of resistance in seasonal H1N1 viruses showed the conventional wisdom was unfounded.

Laboratories around the world are on the lookout for changes in the pandemic viruses that might suggest a similar problem of resistance is emerging in them. But so far, no evidence has been found, Penn said.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

US swine flu patients on immunosuppressant drugs develop Tamiflu resistance
By Helen Branswell Medical Reporter (CP) – 3 hours ago
http://www.google.com/hostednews/ca...40p8MsxNzEVCjkg


Two cases of Tamiflu-resistant swine flu have been found in the United States, in leukemia patients who were highly immunosuppressed, the U.S. Centers for Disease Control reported Friday.

The cases, both from Seattle, are not linked. And there is no evidence either person transmitted drug-resistant pandemic viruses to either the health-care workers looking after them or their personal contacts.

But the findings underscore the reality that people who are highly immunocompromised and who contract the novel H1N1 virus could generate and spread drug resistant variants of the pandemic virus.

"That's a legitimate public health concern," said Dr. Frederick Hayden, an antiviral expert at the University of Virginia.

These are the first cases of Tamiflu-resistant swine flu found in the United States, though not the first to arise there. Last month it was reported that an California teenager quarantined with swine flu immediately after arriving in Hong Kong was found to be infected with a Tamiflu-resistant strain. She contracted the flu before leaving San Francisco, where she lives.

These new cases highlight the catch-22 of treating pandemic influenza in people who are severely immunosuppressed. These patients should be given flu drugs because their immune status leaves them highly vulnerable to severe illness. But giving them the drugs raises at least the theoretical risk that they will develop and spread antiviral resistant strains of the novel H1N1 flu.

It has been shown with seasonal influenza viruses that people with suppressed immune systems - either from birth, disease or because they are taking anti-rejection drugs following transplant surgery - can have prolonged viral replication when they get sick with flu.

Studies suggest such patients can shed viruses for weeks and even months.

If they are taking antiviral drugs, the longer they shed viruses, the more likely they are to develop resistance to the drugs. And if they develop drug resistance, they could - at least in theory - transmit those resistant viruses to others.

An influenza expert with the CDC said given what's known about flu in immunosuppressed patients, officials are not surprised to see cases of resistance to oseltamivir (Tamiflu's generic name) in this patient population.

"It's not unexpected," Dr. Tim Uyeki said in an interview from Atlanta.

"And it is important for clinicians, family members, caregivers to be aware ... that there is potential for prolonged viral shedding and antiviral resistance to develop in (severely immunocompromised) patients with novel H1N1 virus infection."

Hayden went further, saying it would actually be surprising if cases of drug resistance weren't spotted in highly immunocompromised patients with pandemic H1N1.

"These are the kinds of hosts (patients) where you would really anticipate for drugs - whether it's for flu or other viral infections - that resistance emergence is going to be a problem," he said.

Uyeki said when patients like these come down with flu, they would be tested virtually weekly to see whether they are still shedding viruses and whether they have developed resistance to the medication with which they are being treated.

Health-care workers and contacts of the two patients have been investigated and there is no sign of spread of resistant viruses beyond the two patients, he said.

One case involved a male teenager with leukemia who received a stem cell transplant in early May. While recovering in hospital in a single room he contracted swine flu. It's unclear whether he was infected by a visitor or a member of the hospital staff.

"It's unknown how that infection was acquired," Uyeki said.

That patient has recovered. But the second case, a woman in her 40s, remains in hospital. She also has leukemia and had a stem cell transplant late last year. This spring she went through two rounds of immunosuppressive chemotherapy.

The woman is being treated with an intravenous form of the only other flu drug available, Relenza and another antiviral drug, ribavirin.

Uyeki said the CDC isn't changing its guidance on antiviral treatment as a consequence of the findings.

The agency recommends people who contract pandemic influenza be treated with either Tamiflu or Relenza if they are hospitalized or if they are at high risk of becoming seriously ill because they are pregnant or have a disease known to complicate recovery from flu.

But Uyeki said if there is evidence of Tamiflu resistance or even if it is suspected because a hospitalized or high-risk patient isn't recovering, Relenza should be used if it is available and the patient can tolerate it.

Since the pandemic began, 11 cases of Tamiflu resistance have been reported. Three of those were reported Friday - the two in Seattle and a new case in Hong Kong.

Japan and China have each reported three. In the case of China, one case occurred in Hunan province on the mainland and two in Hong Kong. Canada, Denmark and Singapore have each found one.

Most of these cases have occurred in people who took the drug as treatment for swine flu or to prevent infection with swine flu.

The sole exception so far is the case of the California teenager who travelled to Hong Kong. She had not previously taken Tamiflu, suggesting she was infected from the start with a resistant virus. The source of her infection was not found and no other cases of resistance have been reported from the San Francisco area, where she lives.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

When I read something like this, I think of the UK where all you have to do to get tamiflu is make a phone call, describe your symptoms, and have a friend pick it up. I'd wager many courses have been taken by people who didnt take it properly. And the possibility of someone with SF taking it and developing a resistance, but not monitored, and passing the resistant variety to someone else is probably higher than in other circumstances.

I suspect tamiflu resistance just a matter of time, regardless of how or where it develops.

__________________ 
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Roscoe and Miss Priss

Something about this sentence struck me. These immune-compromised patients are most likely in contact with health-care workers who also see lots of other immune-compromised patients. Sounds like an ideal way to spread a new strain.


MomCares

__________________ 

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

Don't anthropomorphize viruses. They hate that.

"No evidence". Hmm. Not everyone who gets flu exhibits symptoms, yet can spread it, if I am recalling correctly from early bird flu readings. All it would take to transmit the virus - and leave no evidence trail - is for an asymtomatic carrier to be walking around.

__________________ 
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Roscoe and Miss Priss

Canadian Medical Association urges doctors to be immunized for flu
(CP) – 1 day ago
http://www.google.com/hostednews/ca...FTT0OzuvjpAGYgA


SASKATOON — The organization representing Canada's doctors is urging physicians to roll up their own sleeves for a flu shot.

The Canadian Medical Association has passed a resolution encouraging all physicians and other health-care providers to be immunized for influenza annually.

Rhonda Church, a Nova Scotia doctor who tabled the motion Tuesday at the association's annual meeting, said a number of studies have shown that health-care workers are among those with the lowest influenza vaccination rates. She suggested that needs to change in the wake of a predicted swine flu pandemic.

"This issue is particularly important as Canadians continue to become ill with the virus and we face the possibility that the virus may strengthen in the coming months," said Church.

"Health-care workers are of course at increased risk of contracting influenza because of the nature of their work and may pass the virus onto frail or otherwise vulnerable patients under their care even before they're ill."

Church said health workers who provide direct patient care should "consider it their responsibility to obtain influenza vaccination."

Association president Dr. Robert Ouellet told reporters later that doctors can't be forced to get vaccinated.

"Well, doctors are doctors," said Ouellet. "The CMA said we don't want it to be compulsory because some doctors, believe it or not, they don't want to have that and we respect that. Some doctors don't want to have the vaccine - that's their choice."

Ouellet acknowledged that the issue is important and said the association is pushing everyone who works with patients to get vaccinated.

"We will tell our fellow doctors to do that, but if they don't want to do it what can we do?" said Ouellet.

The comments come after Health Minister Leona Aglukkaq told doctors in a speech Monday that they need to stand together with the federal government to face a possible H1N1 flu resurgence this fall. She said Ottawa is working with drug maker GlaxoSmithKline to develop a vaccine and one is on track to be ready by November.

Doctors said Aglukkaq's speech lacked details on a flu vaccine plan, including information about who should get the vaccine first.

__________________ 

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

Don't anthropomorphize viruses. They hate that.

>>>>studies have shown that health-care workers are among those with the lowest influenza vaccination rates



Hmmm, makes you wonder why so many educated and informed health professionals would choose NOT to be vaccinated, doesn't it?

__________________ 
“When the going gets weird, the weird turn pro.” - Hunter S. Thompson

Not because they are all well educated as the portion of nurses not being vaccinated is much higher than docs not being vaccinated.
Most docs I know are vaccinated every year. And those who are not are a) lazy of b) feel invincible or c) catch it soon anyway.
I have yet to hear a single doc (no matter wether they are particularly smart or informed) have a single medical or scientific reason not to get a flu vaccination.

It is the typical semi educated but double paranoid that fear vaccinations.

It is mostly nurses that are reluctant here (and I know a few stupid ones like than from Canada too). But here nurses are not considered educated (and they are not) so their decisions are just as important as if a plumber decides against vaccinations, they know not more than he does about most of the subjects involved. Sorry. Nothing against nurses, but here (I know in other countries they do go to university or similar higher education, not here though) they have no great education and only a few really good older ones with lots of experience are worth consulting regarding specific medical issues.

Nurses aren't educated? My mother had 4 years of college and a degree before she went through 2 additional years of nursing school. I have known quite a few well-educated and intelligent nurses over the years.... older AND younger with anywhere between 4 & 6 years of college.

I do not believe they are refusing vaccines because of a lack of education. They do, after all, have the highest exposure rate over anyone else, do they not?

I'm pretty sure if I were in the same position, I would weigh ALL material and information carefully before I did or did not take a vaccine. Wouldn't you?

__________________ 
“When the going gets weird, the weird turn pro.” - Hunter S. Thompson

iBurn, I believe Highflyer was talking about nurses in Germany not being as educated.

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Roscoe and Miss Priss

No H1N1 viruses isolated from CFIA inspectors, can't compare to pig viruses
By Helen Branswell Medical Reporter (CP)
http://www.google.com/hostednews/ca...8jywzM9V9kw1Q2g


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 fueling 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.

"They are very similar and more than 99 per cent similar," Alexandersen said. "There's nothing that looks specific or interesting at this point."

The lab, which shares a campus with the National Microbiology Laboratory, is also sequencing virus samples taken from a pig herd in Quebec where the novel H1N1 virus was found.

That work isn't yet completed, but Alexandersen said the picture so far is much like the one seen with the Alberta pig isolates.

"Nothing interesting or particular. It's again very, very similar," he said.

__________________ 

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

Don't anthropomorphize viruses. They hate that.