Designed for Much Deadlier Disease, May Create a Perfect Storm
August 09, 2009 By Meryl Nass, MD
1. The US government is using laws designed for dealing with a very deadly pandemic or bioterrorism to bring in a mass vaccination program for swine flu, specifically the Public Readiness and Emergency Preparedness Act of 2006.
2. This law removes liability from the manufacturer, medical practitioners who use the product, and from “government program planners” who decided on using the law. A suit can only be brought if the DHHS Secretary allows it, and if there is willful misconduct on the part of the manufacturer.
This law has been invoked for swine flu drugs (tamiflu and relenza)
for swine flu vaccines, and for novel vaccine adjuvants (which may be used in vaccines to stretch the supply and possibly convey broader immunity)
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3. If testing of these products is very limited, then the manufacturers are unlikely to become aware of their flaws, and specifically their adverse effects. Then there can be no willful misconduct.
4. Due to the fear that swine flu will cause a large outbreak once students return to schools, where the virus might rapidly spread, the US government has stated that vaccine is likely to be available, and used, before clinical trials are completed.
WHO says vaccine will be ready in September. Novartis began testing in humans in late July, and Sanofi-Aventis and Glaxo-Smith Kline are starting now.
The Europeans are also planning for use before testing is completed, despite warnings by experts about the potential dangers of untested vaccines.
5. The adjuvants likely to be used to strengthen vaccines and stretch the supply are named MF59 (Novartis) and ASO3 (Glaxo Smith-Kline). Only 3 vaccines using this type of adjuvant (oil-in-water, a.k.a. squalene-containing) have been licensed in Europe, and none have been given a license in the US. Two vaccines using these adjuvants are only used in people above the age of 65 (Fluad-MF59), and those with serious kidney disease (Fendrix-ASO4). Both advanced age and kidney failure weaken the immune system, so more powerful vaccines are needed, but in this population autoimmunity is unlikely to result from powerful immune stimulation. Cervarix is the third European vaccine (using adjuvant ASO4 against HPV) and its safety is controversial.