The "experts" have spoken to WHO and WHO has spoken to us: because of the march of science, there's been a large upswing in the estimates of how much vaccine the world could produce in a pandemic -- if such a vaccine existed and there was a way to deliver it. But if there was one and it could be delivered, then WHO thinks we could produce up to a 4.5 billion doses by 2010 as a result of new manufacturing technologies and techniques to make the produced antigen go farther. A lot of "ifs," to be sure, but without the ability to make the stuff the rest doesn't matter.
At the moment we make a half billion doses of seasonal flu vaccine a year (up from half that), but this capacity would have to double to a billion and be diverted entirely to the pandemic strain. WHO's Press Release, lightly but faithfully edited by news outlets like Dow Jones Online, is still upbeat. Press release stenography is no substitute for reporting (although it has become the norm for the American press), so it's good to have excellent reporters like Canadian Press's Helen Branwell around who ask the right questions and knows the right people to ask them of:
The World Health Organization issued an optimistic update on prospects for pandemic influenza vaccine Tuesday. But industry insiders and public health experts wondered if tinted glasses were casting an overly rosy glow over the global vaccine production situation.And some openly admitted the efforts to grow production potential could soon lead to a glut in seasonal flu vaccine stockpiles.
"We are very concerned about an overcapacity situation," said Len Lavenda, a spokesperson for the industry's biggest player, sanofi pasteur.
At a news conference in Geneva, the senior WHO official in charge of the pandemic vaccine file said the effect of expanded manufacturing capacity for seasonal flu vaccine, coupled with the success of vaccine-stretching compounds known as adjuvants, means several billion more people could be vaccinated if a pandemic occurs in the next few years. (Helen Branswell, Canadian Press)
Here's the problem. Our current capacity to produce the trivalent seasonal influenza vaccine is nowhere near sufficient to supply the demand during a pandemic, even assuming that the current plants would be quickly and completely switched to the new pandemic strain. In terms of demand for seasonal flu vaccine, however, there is insufficient demand. Every year unused doses are destroyed. Thus the "market" doesn't work to assure us sufficient productive capacity for a pandemic that hasn't occurred yet and whose timing, severity and very existence is in doubt. And Big Pharma has noticed:
"I can only speak for sanofi pasteur. But we're the largest supplier. We're producing over 40 per cent of the world's flu vaccine. And we are very concerned about an overcapacity situation."
"That's not healthy for industry."
He said overproduction could drive some producers out of the field. He pointed to the recent past, when Wyeth Pharmaceuticals withdrew from the flu vaccine production market in 2002 rather than incur the cost of upgrading an aging plant.
"You don't have to turn the history book back too many chapters to see that that's real, that's not idle, that's not just a theoretical possibility. That's reality," Lavenda said.
An industry association director also questioned the sustainability of a one billion dose a year flu vaccine market.
"If there is enough demand they are ready to increase it up to about one billion - that's max, max, max. You're talking about 24 hours, seven days a week, 12 month whole production," said Dr. Ryoko Krause, of the International Federation of Pharmaceutical Manufacturers and Associations.
"But if there's no demand it's not going to increase," she said from Geneva. "We have always said that there's no way that the industry is going to keep producing or keep the capacity unused just for the potential of creating one billion doses."
The obvious conclusion is that keeping the influenza vaccine business in private hands and letting The Market takes its course is a recipe for failure. Big Pharma won't do the overbuilding required. That's a public function. Sometimes inefficiency and redundancy are the only solutions for sufficient stand-by capacity to produce vaccine in a pandemic -- should an effective vaccine exist.
That means international cooperation to build a network of Regional Influenza Vaccine Institutes, perhaps ten to twelve, globally distributed and each with sufficient capacity to fulfill all regional seasonal influenza vaccine needs and enough reserve capacity to ramp up to supply its region, at cost, with a pandemic strain vaccine. This would also address the inequity issue that is threatening to scuttle the current surveillance system. A lot of vaccine will be go unused in this scenario, too. But it will at least be there when and if needed.
Big Pharma has a good point. We should listen to them. They aren't the ones to do the job. And they won't.
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your 500M of seasonal vaccine - that's trivalent vaccine.
Multiply by 3 for monovalent H5N1 vaccine !
I don't think the yields are the same.
Nor is the amount to be needed known by quantity to produce the required levels to ensure some protection. Logistically speaking it took the Chinese 8 months to vaccinate chickens with an off antigen flu vaccine... or so they say.
Thats if everyone is herded into vaccination clinics. That ensures pandemic flu infection while standing line. Drive thru clinics? Gimme a break. We would have to open thousands of clinics and if its a one to three part vaccination the pandemic would gone and over before we got to the next wave that the vaccine might not even work on. Plus they make assumptions that there would be fuel to do it. Not the brightest of ideas. Tenn has a plan to do it but no in place and standing contracts or people, facilities. Its going to be knee jerk response.
You have heard me say it before and that is that we will have to embrace the horror. That is that if the vaccine takes six months to make and w/wo regional facilities there still will be a four month event. Pandemic wave gone in that time. Remember the flu vaccine media-ocrity of three years ago... OMG we dont have flu vaccine.... OMG we have to hype it.... OMG they dont take personal responsibility for getting the shots early.... Then of course the Dems turn right around and blame Bush.... horseshit. They wouldnt take until it becomes an issue and that is the worst flu season in years in many places. Did the media pop up and tell them that taking the flu shot doesnt produce real protection and whatever level it was takes about a month to produce in your body? Neyope!
The media in the above is doing a poor job of really reporting the "news" and that is that even if we had the antigenic pattern and they started production in these regional facilities, it wouldnt matter. By the time they got the first batch of flu out of the oven and assuming that none of their people were sick, we would already be too far down the road to save anyone BUT those people listed.
The worst thing though Revere IMO is that government could get involved in production and distributiion. They are too stupid to do that. They could direct and they are good at that. They could contract it out but its government. They never look beyond 5 minutes. Besides, it is and will be a states problem on how they handle it anyway. If it were manufactured in the US I would anticipate that without federal control of the vaccine that states would bushwhack the trucks to divert the vaccine to their uses. I can see this stuff going out on armored convoys if this is an ugly, ugly hit. What would people do to protect their children or families not knowing that even taking that ambigous shot wouldnt provide protection for weeks if at all and the virus didnt mutate along the way too far off of the vaccine.
Worst case? Yup! But you let this hit hard, fast and furious with a CFR at 8% or above and the infrastructure is going to crumble like a cookie.
At www.cidrup.umn.edu there is the 1st part of a 7 part series on the Pandemic Vaccine Puzzle. I quote:
But after almost a decade of research, a safe, effective, affordable, and abundant vaccine against H5N1 flu remains disappointingly out of reach. The search for a human avian-flu vaccine that could be developed and delivered in time to short-circuit a pandemic has been dogged by multiple obstacles across many sectors. They include patchy scientific knowledge, sparse government funding, thin manufacturing and packaging capability, and restrictive regulatory structuresalong with the wily immunology of the H5N1 virus itself.
Despite recent encouraging news from several clinical trials, the scientificand financial and politicalhurdles to producing a widely deployable vaccine remain dauntingly high. As the WHO admitted in its Global Pandemic Influenza Action Plan, published last year, "At the present time, if an influenza pandemic were to occur, the potential vaccine supply would fall several billion doses short of the amount needed to provide protection to the global population" (see Bibliography: WHO 2006).
The problems M. Randolph Kruger talked about are real.
It will take 6 months to produce the vaccine, and that is after the pandemic has arrived. The problem is the H5N1 virus mutates very rapidly,and the current vaccine may not work.
Of course every effort should be made to provide a vaccine in large quantities, but to believe it will actually be done is an illusion. There are just too many complications to overcome. The vaccine, if it does arrive, will be too little, and too late to do much good. And it may even be useless, if the virus mutates to a strain that is not in the vaccine.
Realistically, we will probably not be much better protected than those that lived through the Spanish Flu Pandemic of 1918. Anyone that tells you otherwise is creating an unrealistic false hope.