The global swine flu vaccine shortage

The US has ordered 250 million doses of swine flu vaccine, mainly from foreign manufacturers. That's a large proportion of the world's productive capacity. A couple of the biggest vaccine makers, Glaxo-SmithKline (GSK) and Sanofi Pasteur, have promised to make donations to WHO for use in the poorer countries and with some smaller donations that's maybe 160 million doses. Countries like the US that earlier had pledged 10% of their supply have yet to do so, and given the political problems of sending overseas vaccine when there's not enough for US citizens, well, good luck with that. So at best we're talking maybe 200 million doses for the poorer parts of the world (about a third of the globe). WHO estimates this might cover 2% of their population. Might. (For a good summary, see Martin Ensirenk's story in Science, 6 November 2009: Vol. 326. no. 5954, p. 782 DOI: 10.1126/science.326_782 [sub required], h/t Don S.).

WHO Director General Margaret Chan has talked bravely about "global solidarity" on this matter but it's hollow talk:

"It's probably going to be too little, too late," says David Fidler, an international law professor at Indiana University, Bloomington, and an expert on global health security. Tido von Schoen-Angerer, who directs the Campaign for Access to Essential Medicines for Doctors Without Borders (MSF) in Geneva, calls WHO's operation "largely symbolic." Years of debate and negotiations have failed to produce a system to ensure equal access to the lifesaving vaccines, he says, leaving WHO to distribute mere table crumbs. The only good news, he adds, is that the pandemic is relatively mild. (Martin Enserink, Science)

Everyone has seen this coming. But everyone also decided that we would have to rely on the "market" and the private sector to solve it. Well, not everyone. We have been calling for years for ten or a dozen international regional vaccine institutes to manufacture flu vaccine for their regions, using open licensing and the best technologies. This should be extended to antiretroviral HIV drugs and malaria drugs. We can get the world's best scientists to work on this as a public good, put public licenses on the products and start making and providing them at cost. For years the drug companies shunned vaccines because it wasn't as obscenely profitable as impotence drugs or cholesterol lowering drugs or antidepressants. Now that governments have guaranteed them a market they have rushed in to scarf up the profits.

And now rich nations like the US and the Europeans will leave the rest of the world in the lurch. That's not a surprise. That's what everyone expected. Let's stop depending on the people who run those countries (the drug and insurance companies) to take responsibility they will never take. The world doesn't need them. International financing of research, development and scalable manufacturing, regionally distributed, all under a public license could be undertaken at a fraction of the cost and more efficiency than having a half dozen profit making companies make their own products, differing little but each requiring their own trials and subject to licensing fees and inflated costs. The market doesn't work for public goods like these. If it did we wouldn't be facing a shortage that was foreseeable years ahead of time.

We've been saying this for years, here. We don't expect anyone to listen, even now. We're realists. Unhappy and disgusted realists.

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If I'm not mistaken, here in Asia, Asian countries united to support the SwineFlu prevention campaign in order to minimize or totally eliminate this deadly health problem. Fortunately, I never heard any new victims of this swineflu outbreak. In the first place, we're not that greatly affected here.

Kim Ramsey

This might be one of the better examples of the failure of the Religion of the Free Market Forces that I've seen.

I can only hope that in the next interpandemic period, which may be shorter than we might like, someone does a communique by communique analysis of the World Health Organizations performance.

With medications there's usually patents standing in the way, but what's stopping developing countries from manufacturing their own vaccine?

If we were talking about a "free market" then companies like Protein Sciences would be producing vaccine by the boat load instead of being told by the FDA's advisory panel that because their new, fast to produce (no making a seed strain step required) vaccine is no more safe or effective than the 50 year old egg stuff it doesn't make the cut.

Talking about the "failure of the Religion of the Free Market Forces" in markets that are ENTIRELY un-free free is fatuous.

By Lina Inverse (not verified) on 23 Nov 2009 #permalink

Lina: So you prefer that there be no regulation of vaccines and drugs? Just to be clear. Anything goes in the market place. You are assuming, perfect knowledge for the consumer, right?

revere: Don't put words in my mouth. I'm only talking about limits on economic analysis, not my ideal vaccine production and regulation regime.

E.g. by definition a vaccine is not a public good, if you can deny it to particular people it's doesn't fit the definition. On the other hand herd immunity is a public good.

By Lina Inverse (not verified) on 23 Nov 2009 #permalink

Health is a public good, so doing things to ensure or promote health, such as producing vaccines more efficiently, must be included.

Too bad the U.S. FDA didn't recommend the adjuvanted vaccine, and as far as I can tell, not because of any genuine health concerns, but because people mighnt not like it--in other words, a political feel-good cop-out. It would . A little emulsion makes x vaccine go 4x farther.

Now would be a lovely time to ask people if they thought vaccines cause autism and strike them off the list if they said yes. Just my evil fantasy...

I wish the FDA had also agreed to a pilot project for the new method based on insect cells. The sooner we can go to pure microbiological methods the better.

Lina: Well what were you saying in your comment about Proteins Sciences? That the FDA should have let them make it and use it rather than send it back for more data?

Monado: I, too, wanted the vaccine adjuvanted. But I'll grant that the issue is complex because of the antivaxer movement in the US (and elsewhere). It could have affected other vaccine programs, so it isn't quite straightforward.

international regional vaccine institutes to manufacture flu vaccine for their regions, using open licensing and the best technologies. This should be extended to antiretroviral HIV drugs and malaria drugs. We can get the world's best scientists to work on this as a public good, put public licenses on the products and start making and providing them at cost.

Sounds like a good place for the Bill and Melinda Gates Foundation to spend a few of its Billions.

revere: Currently the FDA proper hasn't decided anything; the advisory panel voted 6-5 to ask for more data on the grounds they couldn't justify approving a new vaccine that's only as safe and as effective as the current egg based ones.

In the ideal world, the FDA proper will say, yes, we understand that, but given its production advantages we feel it's good enough to give it the OK.

Getting back to my general point, this is a concrete demonstration that we aren't talking about a "free market" and therefore attacking "the Religion of the Free Market Forces" is not to the point.

By Lina Inverse (not verified) on 23 Nov 2009 #permalink

Monado: Protein Sciences is the (or one of the) insect cell company; they've done their Phase III??? trial with nearly 5K people and the FDA is currently in the processes of deciding where to go next (see above posting).

They'll get a total of as much as 120-40 or so megabucks over several years from the pandemic vaccine program to continue developing this, build up infrastructure (I hope; they say one industry standard bioreactor can make 100,000 doses per week and it would be good for them to get more than one in house (as a pandemic side note, they say it should take other companies about a month to get up to speed in an emergency)), etc.

I do wonder what the current egg based companies are ... doing with regards to Protein Science's efforts....

By Lina Inverse (not verified) on 23 Nov 2009 #permalink

Lina: Of course we aren't dealing with a completely free market, which requires perfect information on the part of the consumer, reasonable choice/options and rationality. Like a lot of religions, it's a fairy tale world. Now I wasn't the one who said it, but I think it still applies. The Religion of Free Markets is like all religions: false.

I do not see it as obvious that a regional vaccine institute would have been able to make the vaccine grow any faster. Or that individual countries would be willing to cede their approval process to an international body.

For discussion's sake let us assume the latter but not the former. The US accepts adjuvants etc. But still there are not enough vaccines to go around. Say enough only for 10% of those in the world who desire it or even those who "are at significant risk".

Do you seriously see the countries of the Western World telling 90% of their citizens - high producing taxpaying citizens - who feel vulnerable to a disease that they cannot have the vaccine because an equal share is going to protect people in Sudan at no greater risk than they? That they have provided the lion's share of the funding both in absolute and even in percent of GDP and yet they will not get any preferential treatment?

Do you even believe that any of us in our hearts of hearts DO value the lives of the poor in the developing world the same as we do our own? If so then would you be willing to go without food yourself to the point of near starvation so that all your other resources could go to feed the hungry elsewhere? Because that would be what logically follows. And while the best of us may be altruistic, and give generously to charities, we do not do so to the point of putting our own basic needs for food and shelter at risk. Nor those of our family. Nah, we are only unselfish to the point where the discomfort of going without becomes larger than the pleasure we get by giving. Not to equality.

None of the HAVES will put their own at significant risk for the sake of others who are the HAVE NOTS. Not gonna happen. Unrealistic to think it would or even could.

Don S, good point, though I've known exceptions, and certainly during the period known as "the Sixties" (and too often dismissed) the seeking to love others as oneself strongly motivated our actions. I think we can see the tribalism (or, limits of "us") that you mention when we look at what's deforming healthcare reform, too.

Don: Here's the idea. Regional institutes (Africa, S. E. Asia, etc.) would develop and publicly license vaccines on their own. They would set up scalable manufacturing facilities in each region and be free to borrow technologies from any other institute. Each country would then be able to decide if they wanted to allow the use of the vaccine. If the US and EU wanted to depend on the private sector, no problem. And they can have their own licensing. But the problem is that even in these countries there isn't sufficient productive capacity on hand, which is what an ongoing institute would provide. Several US states did make their own vaccines once upon a time. It is possible and can be done. It bypasses the private sector, which is free to compete. No problem. But if the private sector continues to ignore the needs because the market doesn't work (no demand between pandemics or countries too poor to supply the demand), then it is done as a public good.

Where would the funding for each regional institute come from? You are talking about a very costly infrastructure and being scalable is different than being able to scale up quickly in real pandemic time.

Could Africa afford such a regional institute on its own? Does it have the intellectual capital to do so?

If each institute can freely borrow from the other then what do you do about the "freeloader" institute who does no costly development or testing but just borrows from the others?

Do you realistically imagine North Korea, China, Japan, Taiwan, South Korea, and Russia, let alone the other disparate governments of the Asia region working together on a development project, funding it in a mutually agreeable manner, and agreeing to a common licensing scheme?

Sorry to be such a cynic.

Don: I envision this as an international (e.g., UN) sponsored endeavor but the current rage is for "public private partnerships" like the Gates or Clinton Foundations. Yes, it's costly, but in the scheme of things, a few billion is chump change compared to the savings. And who cares out free rides? I'm free riding off the efforts of scientists all over the world.

Here(Sweden) several international health experts are advising our country to NOT send our excess supply of vaccines (we ordered 18 million doses for our 9 million population). They argue that it would do more harm than good, risking that we "force" them to spend time on vaccination against the swine flu, rather than on more urgent matters. In many countries in e.g. Africa health centres have not enough resources and time to do the most highly prioritized things today. And even though the western world is at a scare for the swine flu, many African regions have much bigger health problems. Rather send them pneumococcal vaccines.

MikS: Pneumococcal vaccines and other things can be done at the same time as swine flu. This seems like a strange position to take. And if Ethiopia doesn't want to use the vaccine, no one is forcing them to. What do they propose you do with the extra 9 million doses?

the Netherlands has also ordered a double dose to the population - 32 million for 16 million population. This also puzzles me, since our version should be the effective one, not requiring double shots.

One theory is that by ordering lots, you get a bigger portion of each batch that is made.

re cynicism or re sharing--someone here who's been saying he'll go after vaccine out of turn if necessary just got a chance today and, learning how few doses were available for persons probably more at risk, let the chance go.

"The Religion of Free Markets is like all religions: false."

Just like the Religion of Socalism which you seem to subscribe to.

I think if the government(s) was completely in charge of this whole thing, the H1N1 vaccine would not have hit the field as quick as it did. That's my experience having spent over a decade each working for the govt and private industry.

GeorgeT @ 23.

The Australian government was completely in charge of manufacture and distribution here. No shortages and everyone who wanted it got it at no charge weeks ago.

By Keith Harwood (not verified) on 24 Nov 2009 #permalink

Keith is right - the Australian government made enough doses available free of charge for every man, woman and ch8ld in the country, and rolled out the vaccination program by about the beginning of September, using vaccine manufactured in Australia.

You could get the vaccination from a regional government clinic or your own private primary care doctor, free of charge either way. The public response was very good, and so far I have seen no reports of adverse reactions.

OK, we have a population of only 21 million, but then that means we have only proportional resources.

I have no interest in politics as ideology (as opposed to policy making) one way or the other, but having the government fully in charge of some things really does seem like a good idea.

By Ssndgroper (not verified) on 27 Nov 2009 #permalink