Red flag on the flu vaccine front

A story in CIDRAP News by the always excellent science journalist Maryn McKenna provides food for thought:.

A flu vaccine manufacturer's decision not to build a US facility has highlighted the perpetual mismatch between flu-shot supply and demand--and the reality that the mismatch may undermine plans for pandemic flu vaccines.

On Tuesday, Solvay Pharmaceuticals Inc. of Marietta, Ga., announced that it was canceling plans to build a US flu-vaccine manufacturing plant, a $386 million project that Birmingham, Ala., and Athens, Ga., have been competing for. The plant would have made both seasonal and pandemic flu vaccines--but at just about the moment when a final site selection was expected, the company announced that the economics of the two-year-old deal no longer make sense. (Maryn McKenna, CIDRAP News)

The US Government sunk almost $300 million into Solvay for design and development of the new plant but didn't provide enough for capitalizing it. Apparently to make economic sense some companies require that someone else pay all the upfront costs. I'm sure this is true for Solvay, a chemical, plastics and pharmaceutical conglomerate based in Belgium. Why invest a dollar (or a Euro) in flu vaccine, even though it will make you a tidy profit, when you can invest in some other product that can make you a big profit. That makes business sense. So the losers in this one are US taxpayers (so what else is new?). But the problem, as McKenna points out, is probably deeper than a bad investment of tax dollars:

Nevertheless, the Solvay decision deprives the United States of a domestic source for pandemic flu vaccine if or when a global outbreak begins. And by refusing to offer supply into an uncertain market, the company is challenging the central assumption behind US and global planning for pandemic-vaccine capacity: that demand for seasonal vaccine will provide companies with a rationale for making more vaccine than they now do.

Federal health officials have asserted many times that demand will boost manufacturing capacity to the level needed for a pandemic. To reach that level, the World Health Organization's 2006 "Global Pandemic Influenza Action Plan" calls for countries to boost their flu-shot usage to 75% of their populations, including countries where seasonal vaccine has never been used.

Here's how I would say this: the market doesn't work for flu vaccine. It is like saying that a war is like the market and will call up a demand for an army. so between wars we can disband the military. I might like that, but if you believe there are real threats out there requiring a military this would be nonsense to you. Since most scientists think there is a pandemic threat out there, why should we let "the market" govern if we have the resources if and when we need them? Because the US government, especially this administration but not only this administration, worships the market (except when they don't) and kowtows to drug companies (almost always).

If the market doesn't work for flu vaccine I see no reason to throw up our hands and give up. We construct another mechanism. In this case it could be a global network of regional vaccine laboratories (maybe ten or a dozen, with some large regions, like the US, having several) that have adequate reserve capacity to ramp up production quickly in the case of need. In the absence of demand this produces unused and redundant capacity and is inefficient. As do standing armies in times of peace. The cost would be borne by the global community as a whole.

The alternative is to do as we are dong now, leave it to the private sector which has no incentive to meet the need, and should a pandemic arise will be able to respond too little, too late and at great cost, both because the demand will exceed supply and the loss in pain in suffering from the missed opportunity will be enormous.

The Solvay decision is another warning flag. Of course, we have shown a prodigious capacity to ignore warning flags

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Great analogy to war... it's about time we had a war on something important where we could have an effect.
You are describing yet another market failure. The crony capitalists like to tout the benefits of the free market when it means subsidies and protections for them (not really a free market) but don't admit to the problem of market failure.
The US health care system is a case study in market failure with the sole exception of the socialist Medicare program (in an irony hopelessly beyond Palins ability to comprehend, this is what he was referring to when he warned that without vigilance, "you and I are going to spend our sunset years...").

I have been argueing the case that pandemic vaccine production should be treated, and funded, as a matter of national security I am not even going to try and re-write it again now. The text below is just a straight cut'n'paste from an earlier post.

It may be useful to split the vaccine problem in two - seasonal & pandemic. Seasonal vaccine has been supporting itself - commercially - so far and while the major players have been in no great hurry to pay for certification of a new (not egg based) manufacturing process cell based production is here. Pandemic vaccine needs much the same end product but the timings are a little different. Seasonal flu vaccines manufacturing capacity survives on regular alternating orders from the north and south hemisphere. These orders are placed 6 months in advance and are predictable in size and timing. If you want to supply the pandemic trade you will need capacity to produce a billion odd doses at a few weeks notice and you may only get an order every 30 or 40 years. This is understandably not the kind of business plan that is going to draw investors. If you build a plant to meet this surge the chances are it will be obsolete before it is needed, also egg based production is a non starter as it can not deliver given the short time between pandemic onset and peak infection period.
Either we just accept these things happen and accept the odd culling of mankind or we devise a plan to cope with these periodic attacks on humanity. If we conclude that a massive investment to mitigate the effects of a severe flu pandemic are worth paying for - not a no brainer as there are plenty of other problems that could benefit from this level of global commitment - then I would argue that this is a national security issue and should be treated - and funded - as such. While advocating a major effort in pandemic planning what I am implicitly planning for is not any old flu pandemic (1957 / 1968) but a 1918+ pandemic, the distinction is important. In a 1918+ pandemic you can not devise a xenophobic plan, protecting you citizens alone does not solve the problem as the collateral damage to the worlds economy would leave them healthy but wishing this recession was mild like the 1930's. Enlightened self interest means the richer nations need to pay for and implement a plan that covers most of the worlds people regardless of the fact they can not pay themselves - this is the price we pay for being relatively comfortably off and wanting to stay that way.

Re-reading the above I am not sure I made one key point very clearly. The seasonal vaccine program is a hindrance to the development of a pandemic vaccine program.

The options, as I see them, are

Pay the Pharmaceutical industry to switch to a cell - or monoclonal antibody - based system and maintain pandemic surge capacity.

Pay for the upgrading of the veterinary vaccine capacity as above and maintain it as dual use so it can be switched to human production in a pandemic.

Any other suggestions?

The military apparently already takes care of its own with an influenza vaccine program.
"All military members are required to be vaccinated against the flu each year."

I don't know, but I imagine soldiers are being immunized in their home bases -- so the manufacture, distribution, and the rest of the facilities already exist to immunize the military, and could, with some careful planning, likely be scaled up to cover the rest of the population in the event of a pandemic flu.

Australia has been so far ahead of the curveball on prepandemic vaccine research eg. new adjuvants and delivery modes, it feels almost...Prescient!?!

Indeed crf, I myself became a tad worried back in 1997, watching an Oz SBS television newsreport on human H5N1 fatalities in Hong Kong (my lover from that time is Chinese-Australian, whose family hails from that region of China).

Unfortunately, like a "prescient" child yet to physically "join all the dots to form a coherent picture", I began blabbin' on 'bout an "impending global disaster" minus the physical proof.

Tsk, the West Australian medicolegal homophobes saw a "tasty meal" in me and gorged themselves... The criminal violence vomitted at me has left me utterly contemptuous of all West Australian government agencies -- as bored spoitbrat tossers (of all ages) working in state government jobs take psychosexual pleasure enacting the "Orwellian infantalization process" of 1984.

But crf, I digress... Yes, a former US-military mate of mine (Randy Kruger) has posted on EM many times complaining he had no choice but to take whatever vaccines the military command threw at serving members. So yeah crf, the US production capacity IS there...

The only thang the American public needs now is highly EFFICIENT prepandemic vaccine adjuvants and delivery modes... And who has that!?! The arrogant Aussies, of course!

@ ScienceDirect -- "The utility of ISCOMATRIX adjuvant for dose reduction of antigen for vaccines requiring antibody responses" Vaccine 30 March 2007…

Excerpt: "The capacity of an adjuvant to reduce the amount of antigen required in vaccines would be beneficial in a variety of settings, including situations where antigen is difficult or expensive to manufacture, or in situations where demand exceeds production capacity, such as pandemic influenza. The ability to reduce antigen dose would also be a significant advantage in combination vaccines, and vaccines that by necessity must contain multiple antigens to accommodate variability between strains or genotypes... Therefore, ISCOMATRIX adjuvant has the potential to substantially reduce the dose of antigen required in human vaccines, without compromising the immune response."

Again @ -- "Pulmonary delivery of ISCOMATRIX influenza vaccine induces both systemic and mucosal immunity with antigen dose sparing" Mucosal Immunology advance online publication 24 September 2008

By Jonathon Singleton (not verified) on 06 Oct 2008 #permalink