http://scienceblogs.com/effectmeasu...s_with.php#more

Playing Grandmaster chess with swine flu
Category: Pandemic preparedness • Swine flu • Vaccines
Posted on: November 3, 2009 6:20 AM, by revere

A reader asked an offline question that is general enough to post about (NB: I try to respond to as many questions as I can, but I'm traveling and can't keep up, so in most cases I won't be able to respond. I also don't hand out personal medical advice over the internet, something I consider bad practice). CDC says on the basis of clinical trials with the unadjuvanted vaccine used in the US that two shots, 21 days apart, are needed for children under 10. WHO, on the other hand, is telling its member nations that one will suffice. Why the confusion?

We may be comparing apples and oranges. Many countries use adjuvants in their vaccines which promote a quicker and more powerful response. It appears that a single dose is sufficient for children under 10 when there is adjuvant in the vaccine. Canada currently is using adjuvant, as are many other countries, although concerns from parents have forced the Canadians to offer an adjuvant-free option. Helen Branswell has an excellent piece with a Q&A on the controversy that you should read in its entirety, but it is pitched to a Canadian audience, so I've take out some of what I consider the more general points:

So that's point one. Every child is in a race with the virus. My 5 year old grandson lost the race and is now suffering through fever, aches, pains and feeling ill from Tamiflu. He has asthma so Relenza is not an option. A couple of weeks more and he would have gotten some protection into him. But the virus got there first.

Or maybe more than a couple of weeks. In the US there is no option to get adjuvanted vaccine if you want your child to be protected faster. Again from Helen Branswell:

With an adjuvanted vaccine, a half dose gives antibody titers thought to provide protection in a single shot in babies 6 months to a year and a half. This is the highest risk age group in the population. But adjuvanted or not adjuvanted, it is likely that one shot is better than none at all. That seems to be WHO's reason for recommending one dose for children under 10. There's a global shortage of vaccine and their objective is to get some protection to as many children as possible. Yesterday we noted the melancholy data on child death from pneumonia. Well over half of these deaths are vaccine preventable. With an influenza pandemic ramping up in the developing world, WHO is trying to stem the tide of child deaths that inevitably will follow in its wake.

There are lots of agonizing decisions to be made and no sure answers. Influenza virus is a wily adversary. It's like playing timed chess with a grand master without knowing all the moves or the rules. But move within a certain period of time we must. Is the move the right one? We'll find out after the game is over.

__________________ 
.
.

Roscoe and Miss Priss

http://www.reuters.com/article/heal...E59J58H20091104

Proposed law would require pay for sick workers
Wed Nov 4, 2009 9:14am EST

By Maggie Fox, Health and Science Editor
WASHINGTON (Reuters)

--snip--

MORE VACCINE READY

In a regular briefing, CDC director Dr. Thomas Frieden said 31.8 million doses of flu vaccine have now become available -- still far short of the minimum of 80 million to 100 million that had been projected for the first week of November.

This number includes vaccine already administered. Frieden said CDC hoped 10 million new doses will have been made available by the end of the week.

He said the pandemic may be having an unexpected side-effect -- increasing demand for the seasonal influenza vaccine. "We think this year will be the highest ever uptake on seasonal flu vaccine," Frieden said.

"We anticipate there being around 114 million doses of seasonal flu vaccine available through the market by the end of the year. It may be there is even greater demand than that by the end of the season."

This includes healthcare workers, who are often reluctant to be vaccinated. In recent years, only around 38 to 40 percent of healthcare workers get flu vaccines, but that percentage may be higher this year, Frieden said.

As with the vaccine against H1N1 swine flu, distribution is slow and patchy for seasonal flu vaccine. "We continue to hear that people are unable to get the vaccine," Frieden said.

The United States buys both seasonal and H1N1 vaccine from five makers -- GlaxoSmithKline Plc, AstraZeneca Plc's MedImmune unit, Novartis, Sanofi-Aventis and CSL Limited.

Some members of Congress and media commentators complained that detainees at Guantanamo Bay -- the U.S. base in Cuba -- would receive H1N1 vaccines when Americans were still struggling to find them.

But White House spokesman Robert Gibbs denied this on Tuesday. "There is no vaccine in Guantanamo and there's no vaccine on the way to Guantanamo," he told reporters

__________________ 
.
.

Roscoe and Miss Priss

http://www.cidrap.umn.edu/cidrap/co...409hearing.html

CDC says vaccine shortage likely to outlast current H1N1 wave
Robert Roos News Editor


Nov 4, 2009 (CIDRAP News) – The head of the Centers for Disease Control and Prevention (CDC) predicted today that the current wave of H1N1 influenza is likely to begin to wane before the shortage of vaccine for it eases.

Dr. Thomas Frieden made the comment at a wide-ranging US House subcommittee session that aired the reasons for and impact of the vaccine delays and the prospects for avoiding a repeat of the problem. The session was streamed over the Web.

"It's likely that the current wave of infection will peak, crest, and begin to decline before there are ample supplies," Frieden told the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. "Whether there'll be another wave of H1N1 between now and May and whether we'll get a different strain, only time will tell."

In a similar vein, an Alabama health official said there may not be enough vaccine doses to immunize people outside the priority groups until late December. He and other officials said the vaccine shortage has hurt the credibility of public health at all levels.

In other comments, federal health officials described the slow growth of the vaccine virus as the fundamental reason for the current vaccine shortage and suggested that vaccine production difficulties are likely to continue as long as the process relies on growing actual flu viruses, as opposed to producing specific viral proteins.

'Virus seems to be winning'
Rep. David Obey, D-Wis., chair of the subcommittee, voiced frustration over the vaccine shortage and said the same kinds of problems in flu vaccine production were discussed back in 2004 and 2005. In opening the session, he said the nation has made significant strides since the pandemic virus emerged, "but despite some successes, the virus seems to be winning."

In a brief update on the H1N1 situation, Frieden said the nation has now had "many, many millions of cases" of the illness, well over 20,000 hospitalizations, and more than 1,000 deaths, including 114 children.

He asserted that the illness "is no more severe than seasonal flu" but affects a different pattern of age-groups, as more than 90% of deaths are in people younger than 65—a sharp contrast to the seasonal virus.

As for the vaccine supply, Frieden said, "With 20-20 hindsight it's clear we should have been more skeptical" about projections of production timing.

Dr. Nicole Lurie, Department of Health and Human Services (HHS) assistant secretary for preparedness and response, said the cumulative vaccine production today reached 32.4 million doses. Despite repeated questions by the committee, she and Frieden firmly refused to make any new predictions about the flow of vaccine.

"To be quite honest, flu is really unpredictable, and we're very hesitant about projecting forward more than week to week, largely because anything could happen," said Lurie.

Shortage's impact on states and localities
Dr. Donald Williamson, Alabama's state health officer, said the vaccine shortage has forced Alabama to change its H1N1 vaccination strategy.

In September Alabama officials were told they could expect to get about 800,000 doses of vaccine by the end of October, but by Oct 23 the estimated amount was cut to about 400,000 doses, Williamson reported.

"Current projections show that 62% of the vaccine coming to Alabama won't be available until after December 1," he said. Further, it may not be possible to expand the vaccine to all Alabamans who want it until late December or January.

Because of the shortfall, the state decided to focus its vaccination efforts on the subpriority groups identified by the CDC and the providers most likely to serve them, rather than the broader priority groups. (The subpriority groups are pregnant women, healthcare workers, children 6 months through 4 years old, caregivers of babies under 6 months, and children between 5 and 18 with health conditions that put them at risk.)

In line with the strategy switch, school-based vaccination clinics have been postponed until late November or early December, Williamson said.

Rob Fulton, director of the St. Paul–Ramsey County Public Health Department in Minnesota, told the committee, "We know that the credibility of the entire public health system is in question because of the slow arrival of vaccine."

Like Williamson, he said the slow flow of doses is disrupting vaccination plans. For example, he said the county is anticipating getting 7,800 doses for school children age 9 and under, but the actual population in this age-group is 20,000. (Two doses of vaccine are recommended for children under age 10.)

Fulton also commented that 135 of his department's 320 employees are involved in the H1N1 response at least part-time, which means they have less time to spend on their regular work.

Williamson said the vaccine shortage not only undermines public health's credibility, but also leads people to question the vaccine's safety. He also voiced concern about the public's willingness to get the immunization later in the season when supplies finally improve.

Root of the problem
In discussion about the cause of the vaccine delays, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said the basic problem was the slow growth of the vaccine virus in eggs, in combination with the timing of the epidemic.

The virus emerged in April, about 3 months later than planning for seasonal flu vaccine normally begins, he said. Then the virus never went away in the summer and was waiting when children went back to school, sparking an epidemic much earlier in the fall than usual, he added.

"You have flu waiting for you when the kids go back to school and you have a slow grower, that's the answer," Fauci said.

Obey asked if the need to provide some vaccine free of thimerosal, a mercury-containing preservative, contributed to the vaccine delays. Thimerosal-free vaccine is produced in individual syringes; putting vaccine in multidose vials is faster but requires thimerosal.

Fauci said production of thimerosal-free vaccine probably contributed "a bit" to delays, but was not the major issue. "The fundamental basic problem is the virus not growing well," he said.

Lurie said one of the steps HHS has taken to speed production was to ask the manufacturers to shift production to multidose vials as much as possible.

She acknowledged that HHS so far has ordered the filling and finishing of only 117 million of the total 250 million doses of bulk vaccine it has contracted for. "This week we've issued orders for more vaccine [to be filled and finished] so we don't have a gap," she said. "That 117 million has taken us further into the year than we thought it would."

Lurie said the agency is using a staged approach to filling and finishing because it doesn't want to have a lot of leftover finished vaccine. "It's better to keep it in bulk form so it could be used in the seasonal campaign next year or could be used potentially in the developing world."

Fauci asserted that the vaccine makers are not to blame for the vaccine delays. "I don't want anyone to get the impression that it's the drug companies' fault this has happened," he said. "It's just the nature of the biology of the virus that it created an expectation that there'd be a certain amount."

The 'end game' for vaccine technology
Federal officials were questioned about the use of cell-based methods to make flu vaccines, as is now done to some extent in Europe. Cell-based production is considered more flexible and reliable and somewhat faster than the 1950s method of growing the vaccine virus in chicken eggs.

Lurie noted that a cell-based vaccine plant is being built by Novartis in North Carolina and is expected to be ready to start making vaccine in 2011. But how soon a cell-based flu vaccine will win Food and Drug Administration approval is uncertain, she added.

The Novartis plant "will get us a little shy of halfway to what our pandemic goal will be," to make enough vaccine for the entire population, she said.

Fauci said cell-based technology will be an improvement but is not the final answer to flu vaccine production problems. "We want to take vaccinology into the 21st century by not requiring the virus to grow. . . . The end game is to get away from requiring the virus to grow."

He said a number of newer approaches involve making particular viral proteins instead of growing the whole virus. One example is using baculovirus, an insect virus, to make the gene for hemagglutinin. He said one company is conducting phase 3 trials of a vaccine using that technique.

"What we're going to see over the next years is a gradual transition from egg-based [vaccine] to egg-based with cell-based to advanced molecular technology," Fauci predicted.

But the ultimate goal, he said, is to make a universal flu vaccine—one that targets a component of the flu virus that doesn't change from season to season. Such a vaccine could be made and stored in large quantities, and people wouldn't have to be vaccinated every year.

"That's the plan. That's going to take years," he said.

See also:

House Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies, with links to testimonies and recording of hearing
http://appropriations.house.gov/Sub...sub_lhhse.shtml

Williamson testimony
http://appropriations.house.gov/Wit...onTestimony.pdf

Fulton testimony
http://appropriations.house.gov/Wit...ULTONH1N1DC.pdf

__________________ 
.
.

Roscoe and Miss Priss

It is now mid-November (and at least in the San Francisco Area) people are still waiting and waiting for "priority groups" to get vaccinated. Very few have been, and it is clear that it will be well into December or January before there will be any vaccine for the general population.

Luckily H1N1 is relatively mild, though it still is not consolation for those who have been or will get very sick and perhaps die - many of which could have been prevented by a timely vaccine roll-out. If the H1N1 had been more dangerous or becomes that way in the future - this would be a public health disaster of monumental proportions.

All I can say is that it is totally pathetic that such delays have hampered vaccination efforts. It is the public health version of the US response to hurricane Katrina. If the US can't get the capability to speed up vaccine production in the future, we are seriously flirting with danger - and a preventable one at that. I for one, am shocked that US government officials act totally speechless trying to defend their pathetic response to the vaccination effort. When a HHS official publicly states that the "flu is really unpredictable", we know the situation is totally over their heads.

Vaccine makers and governments knew quite a few months ago what viral yields would be - and probably had a good idea as to when these vaccines would be hitting the public. If they did not, then they are a bunch of incompetent bureaucrats. And college-level biology student could have estimated the future availability once the virus yields of the vaccine strain were known. It also might have been appropriate to spend a few extra dollars in vaccine orders to keep shelves stocked from the beginning. Our country throws money away at the least provocation - yet seems to be pinching pennies when it comes to this pandemic.

Clearly there is a lot that has gone on behind the scenes to delay the vaccine's production and release - information which government officials are pretending is a surprise to them. There's not a whole lot that can be done given the whole scenario of H1N1 as it's unfolded so far. Vaccines will not prevent a good percentage of the population from getting the illness. This should serve as a warning sign for the next pandemic that hits the streets. We may be in the 21st century - but we are really in the 19th century when it comes to reacting to public health situations. Certainly in the US - it's time to smarten up. The past and present indicate that the immediate and future response to this problem has and will be even more pathetic than is the norm.

As a former biotechnology scientist - I am shocked at our incompetence. Granted we need to implement more advance technologies for producing these vaccines. However, we had the capability to use our older technologies - and still are really blowing it (for lack of a better term). To add insult to injury - all the failed attempt at producing enough H1N1 vaccine in time has done is to make the seasonal vaccines much less available. Therefore we now have two public health problems where simple vigilance would have prevented both.

Just curious -- isn't it a bit disingenuous to try to pin the vaccine delays on incompetence on the part of US HHS when that vaccine shortage is a WORLDWIDE phenomena?

Has any country EVER successfully deployed a new flu vaccine in time to prevent a flu pandemic?

Hopefully this will be possible some day soon, but as far as I can tell it's just not possible this time around.

I do agree that this all would have been SO much worse if the virus were any more deadly than it seems to-date.


MomCares

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Let's compare the US and Canada. Canada is even further behind in getting vaccine to their citizens than the US is. Yet they have their own vaccine production facilities as well as are using adjuvanted vaccines which I believe stretches the antigen by a factor of 4. Who is responsible for their delay?

The US on the other hand is importing all it's vaccine (with the exception of FluMist). The US has Baxter producing vaccine, but Baxter has no contract with the US. The US is also not using adjuvants so they need even more antigen.

A vaccine is only effective if people take it. Right now a signficant % (half?) of the US population (including HCW) doesnt want it either because they think they dont need it, or because they think it has been too rushed and might be dangerous. Would having it produced even faster with new methodology make more people trust it? Not likely.

Of course this is not as severe a pandemic as it could have been. More would likely step up to get vax if it were.

As someone who is at the end of the line to receive it, I'd be very happy if new technology were used to produce a faster, safe, effective vaccine for the next pandemic. I hope that happens, but if it does, there are many who will have even greater suspicions. No reason to not go forward however.

Of course a widely available universal vaccine would be the best of all worlds.

__________________ 
.
.

Roscoe and Miss Priss

They can scale up the process - its a question of how much the buyers are willing to pay. The biggest problem with vaccines is that they are not profitable. Unless you get high titers and have lots of time to prepare it - the costs go up - and no one is rushing to make it. Even worse, the producers are so scared of losing money that they hold back (remember Chiron a few years ago? They got clobbered financially by a bad batch.). Certainly the US government could have given financial assurances to the vaccine makers this year - but they apparently did not. Other developed countries could have afforded to do that as well. We are talking a few billion dollars for all the vaccine makers when you have GDP's of many trillions at stake.

Well, the titers of H1N1 weren't high. But these companies could have made more if someone were willing to pay for it. The fact is that everyone is being cheap - some with a reason. The US has no reason - we throw money away like candy - so whats another $1B or so going to matter - a few more clunkers? Instead we have ordered only enough to keep the shelves stocked - but not too stocked at any one time. So none of the vaccine companies are scaling up in any way that will cause them expense - because no one wants to pay them for it.

Now the rest of the world has a reason - especially the poorer countries. The USA does not. I don't know enough about the politics and economics of the Canadian health system to say anything about them. I also suspect a lot more people want the vaccine than are saying so. We (the US) supposedly has received about 30% of orders - yet lines for high risk people are out of this world. If our President is going to get on TV and make a big deal about this pandemic (like he did a couple of months ago), then he'd better come up with the money to make it available.

I won't even go to comment on the FDA. They just make everything harder. New vaccine production methods are ready for fast track. I'm not talking universal vaccines - but rather more advanced methods of making simple vaccines. The FDA sits on their thumbs for years. No one wants to push it because it isn't profitable to make vaccines beyond a point. 20 years ago, biotech companies were coming up with alternative methods of production. They have been mostly shelved because they were not profitable enough to even bother with the FDA or anyone else.

Poland won't buy H1N1 vaccine until 'properly tested'
Nov. 6 2009 2:05 PM ET
http://www.ctv.ca/servlet/ArticleNe...91106?hub=World

WARSAW, Poland — Polish Prime Minister Donald Tusk says his government won't buy vaccines for swine flu that have not been properly tested or from producers who won't take responsibility for possible side effects.

Tusk told reporters Friday that vaccine producers were pressuring governments to buy, but were also demanding that all responsibility and compensation for possible side effects should fall upon the governments purchasing the medicine.

He stressed that the few dozen swine cases in Poland have been mild and no deaths have been reported.



.

__________________ 

Well today, 11/12/09, the CDC announced that 22,000,000 Americans have contacted H1N1 and about 4,000 have died from it. That makes the mortality rate about 1 in 5500. Sorry, but those odds are not normal for influenza. At that kind of mortality rate it is criminal to not vaccinate a country or to screw up vaccine production estimates.

http://www.cidrap.umn.edu/cidrap/co...xercise-jw.html

Officials take a heartland look at pandemic vaccine messages
Lisa Schnirring Staff Writer


Nov 11, 2009 (CIDRAP News) – In an effort to gauge how pandemic vaccine messages are being received outside the Washington, DC, beltway, the US Department of Health and Human Services (HHS) yesterday held a tabletop exercise in Minneapolis and included participants from local media outlets and public health departments.

The tabletop exercise was the HHS's third one to cover pandemic vaccine communications. The last was held on Oct 2 in New York City before states received their first vaccine doses, so yesterday's scenario was unusual because it touched on problems and events related to the actual vaccine rollout.

Manufacturers have had trouble growing the vaccine, and some have reported antigen yields as low as one-third of the seasonal flu vaccine's. The slow-growing virus led federal officials over the past few months to slash vaccine availability estimates for the fall, and they have warned the public to expect bumps in the road as immunization campaigns get up to speed.

During opening statements, Jay Butler, MD, head of the Centers for Disease Control and Prevention (CDC) H1N1 Vaccine Task Force, called the nation's public health response to the pandemic flu outbreak "heroic." He said as of yesterday, slightly more than 41 million vaccine doses were available to states for ordering.

Forrest Sawyer, a former news anchor with ABC and NBC, moderated yesterday's discussion, as he has for several other HHS pandemic tabletop exercises.

Though discussion during the three exercise modules were off the record so that participants could freely discuss their responses to potential communications problems, one of the overarching themes was challenges that the media and state and federal officials face when providing information on supply projections and where people can find doses.

In contrast, much of the focus of the last exercise was on the public's safety perceptions of the new vaccine.

Public health officials from Minnesota and Wisconsin described how they and other states are grappling with allocating scarce vaccine doses to the narrower subgroup within the priority group recommended by the CDC's vaccine advisory group in late July: pregnant women, healthcare workers, household contacts of babies younger than 6 months, children ages 6 months through 4 years, and those between ages 5 and 18 who have underlying medical conditions.

Much of the discussion also centered on how to fine-tune vaccine communications and manage public expectations, particularly amid so much uncertainty.

In prepandemic projections, federal officials predicted that a vaccine to match a circulating virus would be available about 6 months after the virus was identified. Though the launch of the pandemic H1N1 vaccine hit that target, Bruce Gellin, MD, director of the National Vaccine Program at HHS, said pandemic plans didn't account for just a dribble of it at the 6-month mark.

Butler added in his closing comments that the vaccine shortage "shows how chaotic biologic systems are."

See also:

Sep 3 CIDRAP News story "Feds engage media on pandemic vaccine communication"

__________________ 
.
.

Roscoe and Miss Priss

http://www.cidrap.umn.edu/cidrap/co...1109sanofi.html

Sanofi vows to finish making H1N1 vaccine by year's end
Robert Roos News Editor


Nov 11, 2009 (CIDRAP News) – After a slow start in producing H1N1 flu vaccine, Sanofi Pasteur has improved yields threefold and expects to fulfill its government order for 75 million doses by the end of the year, company officials said today.

"We promised to provide 75 million doses by the end of the year, and we'll do exactly what we said we were going to do," Christopher Viehbacher, chief executive officer (CEO) of Sanofi-Aventis, Sanofi Pasteur's corporate parent, told reporters at a briefing that was streamed over the Web today.

The 75 million doses expected from Sanofi make up about 30% of the 251 million doses the Department of Health and Human Services has ordered from five companies. As of Nov 6, about 38 million doses had been produced by all the suppliers.

Wayne Pisano, Sanofi Pasteur president and CEO, said the company will have produced 20 million doses by the end of this week. He said the company is still "a little behind" early projections, as it had originally expected to produce 20 million doses by the end of October, but is catching up.

"In 3 weeks we'll be ahead of schedule," Pisano said.

Sanofi's facilities in Swiftwater, Pa., are also engaged in making 50 million doses of seasonal flu vaccine for the US market—about 45% of the US supply. Officials at the briefing said about 40 million doses have gone out the door so far, and the rest are expected by the end of this month.

Sanofi officials stressed the difficulty of the challenge they faced in developing, testing, and producing the H1N1 vaccine while also making the seasonal vaccine.

Pisano said the company received the vaccine seed virus from the CDC at the end of May and produced the first test lot of vaccine within a month after that.

Four months after getting the seed virus, "after extensive testing, we delivered the first doses to the US government," he said. "Typically this process takes 6 months; this was done in 4 months. No corners were cut. People simply worked 24 hours a day, 7 days a week."

Federal officials have cited low production yields of the egg-based vaccine as the main reason early supplies have been far below what was predicted in the summer and early fall. Sanofi officials assumed that initial production yields from the new vaccine virus would be only about 50% of the historical average, but in reality they turned out to be only about 30% of average, Pisano said.

"But we've been able to improve it threefold to where we're now basically getting the same yields with H1N1 as we do with the seasonal strain," he said.

In other comments, Sanofi officials reiterated their commitment, first announced in June, to give 100 million doses of H1N1 vaccine to the World Health Organization for distribution to needy countries.

Without giving a specific timetable for the donation, Viehbacher said the company is about to begin shipping doses to the WHO and will continue over the next several weeks.

Dr. David Greenberg, Sanofi Pasteur's senior director of scientific and medical affairs, reviewed H1N1 vaccine trial results that the company initially reported in early October. He noted that the National Institutes of Health is conducting six additional trials of the company's vaccine.

See also:

Jun 17 Sanofi news release about plans to give vaccine to the WHO
http://www.sanofipasteur.com/sanofi...eC ode=SP_CORP

Oct 23 CIDRAP News story "More clouds in H1N1 vaccine supply picture"

__________________ 
.
.

Roscoe and Miss Priss

Well, according to CBS news (.com), Britain has received 4 times as many does as the US (I'm not sure if that's per capita), and they are actually getting reduced number of H1N1 cases so far. In a related article it was reported that only 1 of 3 people in the US seeking H1N1 vaccine actually got it (including high risk groups).

Clearly the British have it way over the US in terms of getting their act together in a pandemic. Here (in the US), people are struggling to get taken care of, and Britain is starting to see some containment.

It sounds to me like the US has a lot to learn from Britain. Certainly adding an adjuvant has helped immensely. Scientifically that's a no-brainer, but why the US does not do that is beyond me.

see .... http://www.cbsnews.com/stories/2009...html?tag=exclsv

Are you serious? Because even fewer people would want to even take the vaccine if an adjuvant was added. As it is about half think it's been rushed and is unsafe. There is a very strong anti vax campaign in the US in case you havent noticed.

You may think the entire situation has been handled improperly, and technically you may be partially right, but you cant fight the perception of millions of citizens who dont agree with you.

Unless you are suggesting that vaccinations become manditory to force the doubters to get it, you are ranting up the wrong tree.

__________________ 
.
.

Roscoe and Miss Priss

Oh no, I would never advocate that people take something that they don't want - especially a vaccine. Trust me, I'm not fan of Britain's NHS - they are a bit "state run" for my taste.

But I do think that the US still has a major issue with availability and will continue to do so - probably through February. Check out this story .....

http://www.boston.com/news/health/b...people_hun.html

People all over can't get the vaccine. There may be a legion of "doubters" - but there seem to be a whole lot of people who really want it and cannot get it.

I recall seeing that the total US orders are for 158 million. Well, if more than half the country wants it, then they will still run short.

If we were seeing much higher mortality numbers - then people would be running around covering bases. But we're not seeing that. And there is no transparency. I've searched all over the Internet trying to find specifics as to who is short and why and I find very little.

Its not pandemic preparedness if we have only 1/3 "promised" vaccines in mid-November.

I'm quite sure I saw a story today that said that many docs in the UK have run out of vaccine, so although the NHS is, in fact, far more effective than the US health care system -- particularly when it comes to controlling vaccine delivery -- they don't have the SF vax situation under control either.


MomCares

__________________ 

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

Don't anthropomorphize viruses. They hate that.

Here's the article I'd seen...

Patients {UK} left in limbo as swine flu vaccine supplies dry up
12 Nov 09
By Steve Nowottny
http://www.pulsetoday.co.uk/story.a...ode=4124307&c=2


The Department of Health’s distribution strategy for the swine flu vaccine has come under fire amid reports that a supply shortage has forced larger GP practices to put their vaccination campaigns on hold.

Each practice in England and Wales, regardless of size, has received or will shortly receive an initial delivery of 500 doses of the vaccine, with GPs able to order further deliveries from mid-November.

But surgeries with above-average list sizes are already struggling to keep pace with demand - leaving patients in some areas in limbo.

Dr Toby Davies, a GP in Tidworth, Wiltshire, said his practice had received its initial 500 doses last week, and was already running low.

‘We’re irritated that small practices received the same number of vials as large practice,’ he said. ‘We cannot order any more until 16 November and are told that deliveries will take one to two weeks from that date.’

‘As a result, we have had to delay our programme. The plan was to give 500 vaccines every Saturday morning, but clearly after this coming week we will run out and can’t do any more until the end of the month. Meanwhile neighbouring singlehanded practices have 500 doses – probably more than they need.’

Dr Stephen Strange, a GP at a 24,000 patient practice in south Birmingham, said he was ‘absolutely gobsmacked’ that all practices were receiving the same initial allocation regardless of size.

‘All of our 500 doses are already spoken for by patients,’ he said, adding that his practice has had to ban all opportunistic vaccination of patients until it receives a second delivery of vaccine.

‘If there’s been plenty of time to do planning surely there’s plenty of time to realise a practice with 24,000 patients requires more vaccine than those with 2,000?’

Dr Strange said he had written to the Department of Health directly to ask why it had issued 500 doses per practice, pointing out that at a recent meeting neighbouring practices and PCT officials had both backed a more proportional distribution.

‘Locally, the PCT is saying this is ludicrous,’ he said.

A Department of Health spokesperson said: 'The only fair way to get the limited stock we have to every surgery quickly was, initially, to send one box of vaccine to every GP. This way, patients who are most at risk can be targeted in every surgery. If we sent more boxes to one surgery, that would delay getting vaccine to everyone else.

'GPs should talk to their PCT to discuss arrangements moving forward so that, when we have more supplies, they can be distributed proportionally.'

__________________ 

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

Don't anthropomorphize viruses. They hate that.

I dont disagree with most of what you just said. I am one who would like access to the vaccine but will have to wait.

I think however we have a basic disagreement with 'pandemic perparedness' in relation to a vaccine. It would have been nice, but I never expected the man on the white horse to show up in time to save everyone. I never thought we'd have an effective vaccine this early in the game, much less enough for everyone.

Will we do better in the future? I hope so, esp if the disease is worse. But I doubt it. We are probably better off this time simply because H5N1 has been waiting in the wings and there has been greater focus on preparedness in general.

__________________ 
.
.

Roscoe and Miss Priss

I think this will all teach us to be prepared for future pandemics. It's clear that if H1N1 had been more deadly, we would be in a bad way right now and in the future.

I think this has been a wake up call to a lot of public officials, vaccine makers, and to the general public.

http://www.cidrap.umn.edu/cidrap/co...809vaccine.html

Lawmakers fault H1N1 vaccination strategy
Robert Roos News Editor


Nov 18, 2009 (CIDRAP News) – Leaders of the US Senate Homeland Security Committee sharply critiqued the federal government's H1N1 vaccination strategy yesterday, saying health officials should have recommended targeting only the highest-risk groups as soon as the vaccine delays came to light.

But health officials responded that state and local public health agencies needed flexibility to allocate vaccine supplies as they saw fit. And state and local immunization experts contacted by CIDRAP News today agreed, saying flexibility is necessary given the complexity of matching supplies of different vaccine formulations to the targeted groups.

They also said the root of the public unhappiness over the vaccine shortage lies in overoptimistic expectations created early on by senior federal officials.

At the Senate committee hearing yesterday, Sen. Joe Lieberman, I-Conn., the chairman, and Sen. Susan Collins, R-Me., ranking Republican, argued that the Department of Health and Human Services (HHS) should have called for an exclusive targeting of the most vulnerable groups as soon as it became clear that vaccine deliveries would not come in predicted amounts on the expected schedule.

They referred to the narrower of two sets of target groups identified by the Advisory Committee on Immunization Practices in July. The ACIP, which advises the Centers for Disease Control and Prevention (CDC), recommended H1N1 vaccination for five groups totaling an estimated 159 million people.

But the panel said that if suppliers were short, the vaccine should be reserved for a smaller slice of the population, estimated at about 42 million: pregnant women, healthcare and emergency medical service workers, household contacts of infants younger than 6 months, children ages 6 months through 4 years, and older children at risk for flu complications.

As of yesterday, about 48.5 million doses of vaccine had been made available, according to the CDC. In the summer, HHS officials predicted that 120 million doses would be available in October. Poor growth of the vaccine seed strain has been cited as the primary cause of the slow production.

Senators' critique
Collins told HHS and CDC officials at the hearing that after the vaccine production problems emerged, "I just don't understand why the federal government did not then instruct state and local officials to concentrate on this priority group. I believe that the American people will put the highest priority people first gladly, but if they're not getting a revised distribution plan from the federal government, you're creating chaos."

Similarly, Lieberman commented, "My theory is that . . . HHS and CDC should've done a large national announcement of the reduced list of people who should go out and get vaccine."

Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, said the ACIP discussed this option when it met in October. "We asked the question of them, should we go systematically nationwide for that smaller group? There was an active discussion. What we heard pretty consistently was, 'Leave the flexibility to the states and locals; let them decide whether to prioritize.'"

Lieberman pressed the point repeatedly, saying, "I think this is a case where it would've been better to have a national answer and in this case not go for federalism, not let the states and localities make their own decision, because everybody was focused on national warnings about the disease and the need to get vaccinated."

Schuchat responded, "I think we did feel that the state and local authorities were in a better position to know how to best reach the populations tin their midst." She said some states are mainly using regular medical providers, others are focusing more on public vaccination clinics, and others are using a combination of the two.

She observed tat the situation was complicated by the fact that when vaccine first started flowing in early October, nearly all the doses were the nasal spray formulation, which is approved only for healthy people ages 2 through 49 and not for pregnant women.

States targeting highest-risk groups
Kristen Ehresmann, RN, MPH, immunization director at the Minnesota Department of Health in St. Paul and an ACIP member, said today that a number of states have been targeting the smaller set of priority groups on their own, even without a special national recommendation to that effect.

"That's what we're doing, and I know that's what Wisconsin did, though they've opened it up more recently," she told CIDRAP News.

When the ACIP discussed the target groups, she noted, members talked about the danger of narrowing the target groups too much. "You're always in this really difficult balancing act, whether it's seasonal or H1N1. If you get in a position where you don't have enough vaccine and you start limiting groups, then often what happens is when the supply loosens up, you don't have the response from the people that are waiting. They don't always avail themselves of the vaccine."

Referring to the lawmakers' critique, Ehresmann added, "It's probably a case where people that aren't involved on a daily or yearly basis . . . don't recognize all the challenges that you face when trying to make these decisions. It's kind of a lose-lose when you're looking at it."

Jeffrey Duchin, MD, chief of the communicable disease epidemiology and immunization section for Seattle and King County Public Health in Washington, agreed that it would not have been helpful for federal officials to narrow the vaccine target groups beyond the existing guidance.

"I think that the guidance as it existed was sufficient and adequate to allow those people at highest risk to get vaccinated," he told CIDRAP News. "I don't think it would've been useful to further limit the target groups. One reason is that the ability to deliver vaccine to high-risk patients in a population is a function of the availability of a number of different formulations and local demand among target groups and the ability to access those groups in a timely way."

Duchin, who is an ex officio ACIP member, agreed that many states have already been targeting the smaller set of high-risk groups.

"We basically recommend that our local providers do what makes sense in their practice setting, based on patient risk and the formulations on hand," he said. "It doesn't make sense to prioritize infants when you don't have the infant formulation available. There are a lot of complications based on the multiple formulation, the age indications, and underlying conditions that make it very difficult to start cutting the risk groups too finely."

Ehresmann and Duchin noted that it's hard to say what other approach might have improved the H1N1 vaccine situation. Some have mentioned the idea of targeting the highest-risk groups one at a time, but they cited problems with that.

"I don't know whether that would work, because of the [different] formulations," said Ehresmann. "It's not like you get X amount of vaccine that can be given to anyone. The nasal spray can't be given to pregnant women. There are limits to that."

Duchin agreed, noting that a shortage of thimerosal-free vaccine could hinder reaching some groups. He added that it's not known at this point who is actually at highest risk from the virus.

Excessive promises
He and Ehresmann both cited overpromising of vaccine supplies as the key reason for public discontent over the situation.

"I think the key issue is managing expectations," said Duchin. "Although it's quite remarkable that we have any vaccine now, that is not appreciated and the focus is on the fact that we don't have as much vaccine as we'd like at this time."

"In my mind, the biggest problem was the expectation set at the federal level, above CDC," said Ehresmann. "There was so much talk about all this vaccine that was going to be available; there was no mention of all vagaries of vaccine manufacturing. . . . If they had framed this that we'd be very lucky to get a vaccine, then when it came even in small quantities, it would've been a victory and a delight, instead of a shortage."

At yesterday's hearing, Schuchat acknowledged that too much was promised: "One thing I think we say was a mistake was [that] some of our communications led to the expectation that availability would be higher than it has been."

However, she said recent CDC surveys indicate that the public won't give up on getting the vaccine. "I have tremendous faith in the American public. I hate that they've had to wait, but our surveys tell us that of those who couldn't get it, nine out of ten will try again."

She also commented that CDC surveys suggest "that we're reaching the [vaccine] priority populations in much higher levels than others."

In other testimony at the hearing, Dr. Nicole Lurie, HHS assistant secretary for preparedness and response, said the shortfall in vaccine deliveries last week had to do with Hurricane Ida and problems with temperature sensors, not production problems. Officials had expected about 8 million doses, but only about 3.6 million were delivered.

Lurie said that, because of "the remnants of Hurricane Ida," some manufacturers' insurers didn't want them to ship vaccine, causing a delay. In addition, the temperature sensors for some vaccine lots signaled unsafe temperatures, forcing extra testing, she said.

See also:

Senate Homeland Security Committee information on Nov 17 hearing, including links to statements
http://hsgac.senate.gov/public/inde...f2-9531244f5023

Jul 29 CIDRAP News story "ACIP targets up to 159 million Americans for H1N1 vaccination"

__________________ 
.
.

Roscoe and Miss Priss