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.