Immunocompetent

Here we continue notes from the World Health Organization Pandemic Inflluenza Preparedness Intergovernmental Meeting. Refer to the previous post to read: Pretending You are In Charge (WHO), America Insults the Scientists of the Developing World - Or Is It About Patents?, and Japan's Big Bluffer.

US Shenanigans on Distributing Vaccine Seed Strain

Uncle Sam is up to something untoward when it comes to WHO's (pre)pandemic influenza vaccine seed strains.  Immuncompetent doesn't know for sure what it is; but he's got a hunch.  The issue is the language under discussion that would direct WHO Collaborating Centres to distribute influenza vaccine seed strain.

In addition to providing H5N1 vaccine seed strain to industry (which WHO CC's presently do), most countries want to make sure that the vaccine seed strain is also provided to national influenza centers around the globe or, at least, in the country of origin of the HA gene used in the seed strain.

Although the US professes to be in favor of this, it actually seems to have problems with sharing vaccine seed strains.  To wit, it insists on inserting qualifying language into the paragraph saying, in a limiting fashion, that vaccine seed strain should only be distributed "as broadly as possible". (Key words: "as possible".)

Asked what the heck it means by this, the US response was frankly unintelligble. The closest thing to something coherent that it said was the qualification is necessary "because we know there may be some restrictions upon us".  Whatever the hell that means.

The US also keeps emphasizing that the recipient lab must have acceptable biosafety facilities and practices.  Making this point, the US reminded everyone that "these viruses are highly pathogenic and deadly", so the vaccine seed strain could not be so easily distributed.

What? This is factually incorrect. That's odd, because the US usually gets its technicalities right.

Vaccine seed strains produced by WHO are attenuated (i.e. weakened). They are typically handled at BSL-2 containment. They are not deadly nor highly pathogenic like viruses found in nature because of their lab-adapted genetic backbone and/or altered HA gene. Sadly, the WHO Secretariat did nothing to correct the US - despite WHO having stated less than an hour before that its seed strains are attenuated.

So some biosafety capability (BSL-2) is needed; but the safety requirements are not nearly as stiff as the US claims.

What's up with this American nonsense about "as possible" and "deadly" BSL-2 vaccine viruses?

Immunocompetent thinks the US is looking for a back door in the agreement to raise security and patent issues - to permit it to impose export controls on influenza vaccines (like it presently does for Cuba, North Korea, and some others) and/or patent protections on seed strain (an "additional procedure" that the US has contradictorily argued against).  This may be why they don't want a clear obligation to share vaccine seed strain with developing countries.  They may want to reserve the right to say no to some countries for political reasons (e.g. Cuba) and to make money for patent holders (an in, it's "not possible" to give you the seed strain because you won't pay royalties).

Immunocompetent could be wrong; but that's our guess...

Even if you don't buy this explanation for Uncle Sam's odd behavior, if you think about it, the US position is pretty retrograde nonetheless. There is really no valid reason to refuse to provide WHO vaccine seed strain to anybody who is able to use it to produce effective vaccines.