2004S-0212 - Pandemic Influenza Preparedness Plan
FDA Comment Number : EC8
Submitter : Dr. Susan Smith Date & Time: 10/16/2004 04:10:04
Organization : Rensselaer Polytechnic University
Academia
Category :
Issue Areas/Comments
GENERAL
GENERAL
1) This document has a serious flaw that undermines confidence in all of its conclusions. It does not address fundamental underlying conditions that lead to frequent recombination between viruses from different hosts, a major cause of differences in yearly flu strains and periodic pandemic- causing strains: the agricultural practices in Southeast Asia, where humans, birds, and pigs live in unhygienic proximity. HHS should take the lead with WHO, the World Bank, the health arm of the European Union, regional Asian health organizations, and other international governmental and non-governmental organizations in addressing this problem, which already has great economic and social impacts, even without the inevitable pandemic. This is a long term, very expensive undertaking, but the investment in influenza prevention will be paid back in less work lost, less catastrophic health care costs, and greatly increased ability to prevent widespread outbreak of species-crossing flu strains (as was possible in Holland).

2) The proposals regarding increasing vaccine production capacity are good, but too conservative. The recently announced vaccine shortage made it clear that relying on two companies to meet even current vaccine needs is unwise. At least 10 companies, foundations, and/or other research organizations should be recruited through contracts for development of other vaccine manufacturing methods, development of new types of vaccines, etc. Contracts should include provisions for the government to order increased production in case of emergency. We pay lip service to the development of a 'bioshield' capable of protecting the population against engineered threats, but in reality we cannot even adequately deal with threats that periodically arise through natural gene transfer.

3) More production and stockpiling of existing antiviral drugs is a clear necessity, and development of new drugs is also imperative. Again, this draft is too conservative. Many more companies and other research organizations should be recruited to participate in this effort through government contracts and grants. Government contracts and grants for this work should also contain provisions for ordering of increased production in case of emergency.

4) Vaccination for flu of all school-age children in public schools in the U.S. should be required and conducted routinely at the schools themselves. This policy would have the immediate advantages that large amounts of vaccine would have to be produced every year, increasing the existing production capacity; distribution could be shifted in case of pandemic. In addition, several studies have shown that schools are essentially incubation vessels for flu and other viruses; reducing the incidence of flu in schools would cut down on yearly flu incidence in the general population, which would have immediate beneficial economic impacts.

5) As was also made clear by the recently announced vaccine shortage, in the case of a pandemic or other health emergency, government health organizations should control the supply and delivery of flu vaccines and antiviral treatments. Federal support to schools, hospitals and other health organizations can be subject to requisition of facilities and staff to dispense vaccine and/or antiviral treatments in case of national emergency; failure to do so will result in ridiculous local decisions (as we have seen in this flu vaccine shortage) that will have disastrous health, economic, and social effects in the case of a pandemic. Social unrest (read widespread riots and looting) will inevitably occur during a pandemic as soon as people
realize that the distribution is being conducted inequitably, which will happen (as we have seen in the latest vaccine shortage) if left to private organizations. The priority of distribution as laid out in the draft document seems reasonable. It should be made enforceable.