Saturday, February 19, 2005

Stockpiling bird flu vaccine

New Scientist has reported that WHO is changing its position regarding stockpiling of H5N1 vaccine prior to influenza season. The story quotes Klaus Stöhr, chief of WHO's Global Influenza Programme: "When we realised H5N1 is not going to be eradicated in poultry in Asia for at least another couple of years, that made the risk of H5 much higher." Ordinarily WHO advises waiting until there is better information regarding which strain of flu is responsible for a pandemic.

A follow-up to this story by the Center for Infectious Disease Research and Policy (CIDRAP) confirmed WHO will shortly advise member states regarding the advisability of stockpiling vaccine in advance of a pandemic, although WHO did not characterize it as a major policy shift:
"There is a paper which WHO has been developing, which looks at the pros and cons of stockpiling H5N1 vaccine," Thompson told CIDRAP News in [an] e-mail message. "The paper, which will be formally published in about 4 weeks time, states that those which can (wealthy countries) may want to consider stockpiling H5N1 as part of their larger flu pandemic preparedness as it could serve as part of a first response."

But he said the paper also describes three disadvantages of stockpiling: H5N1 may not match the pandemic strain, the vaccine's shelf life of up to 2 years is relatively short, and, because companies have not yet begun clinical trials, licensing of the vaccine is months away.
It is thought that for strains like H5N1, not previously encountered by human populations, two shots may be necessary. It is thus possible that a "generic" (not perfectly matched) H5 vaccine might still provide partial protection and serve as a priming stimulus for a second shot which would provide full protection.

However, even getting this kind of a head start will be difficult as there is little production capacity given the size of the global population. The US plans to stockpile 4 million doses but so far only half has been produced by the US firm of Sanofi-Pasteur (formerly Aventis-Pasteur). Amazingly, the US turned its order for the other half over to Chiron, the company that sent half of this year's influenza vaccine down the chute when its plant in the UK became contaminated. That pilot factory, at the same site in Liverpool, cannot start to make the genetically engineered viruses until the contamination problems at the regular vaccine plant are fixed. Jeez.

Meanwhile some limited safety and dose ranging trials are set to start in the US with the H5N1 strain now circulating in Asia. Similar trials are planned for Japan, Australia and the Netherlands. The New Scientist notes there is some disagreement among experts as to whether stockpiling H5 vaccine, or stockpiling antivirals like oseltamivir (Tamiflu), is the proper route to take, although for oseltamivir, too, production capacity is limited.

It seems clear to us that governments should be taking every available route as quickly as possible. If some vaccine or antivirals go to waste, so much the better because it will mean there is no pandemic and we have more time to prepare. What is distressing is the failure to work out flexible and reasonable licensing agreements with the pharmaceutical companies, for either vaccines or antivirals, so that more production facilities can be constructed and put into operation in more places, more quickly. In the current situation, stocks of vaccine or antivirals will be grossly inadequate in the event of a pandemic, with existing supplies likely available only to wealthy developed nations.

No way to prepare for a potential global public health catastrophe.