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)
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.
6. The then-Acting DHHS Secretary issued an Emergency Declaration in response to the swine flu epidemic on April 26, 2009. This allows use of unapproved (unlicensed) medical treatments and tests, or use of approved treatments for unapproved uses.
According to the Congressional Research Service, on April 27, 2009, the Food and Drug Administration issued four Emergency Use Authorizations in response to requests from the CDC to make available certain drugs, diagnostic tests and respiratory protection devices.
7. Vaccines containing MF59 and ASO3 have not had Emergency Use Authorizations issued for them–yet. However, the government has purchased $698 million dollars’ worth of these adjuvants in recent weeks.
US and WHO officials have indicated the likelihood of their use, which is the only way to achieve adequate amounts of vaccine for the US and world population in the fall.
8. These vaccines have never been demonstrated to be safe in children, pregnant women or young adults. They have not undergone comprehensive testing; for example, MF59 has not and will not be tested for carcinogenicity by the manufacturer.
See page 391 re MF59 carcinogenicity testing, according to a Novartis scientist.
9. The result of the new bioterrorism laws (passed with the expectation of use for much more dangerous epidemics than the current swine flu), which allow use of untested products AND give manufacturers an incentive to avoid comprehensive testing (to avoid being found guilty of willful misconduct) have combined with the political imperative to provide citizens vaccines in a hurry, yielding a Perfect Storm.
In the 1976 swine flu vaccine program, 40 million people were vaccinated with an inadequately tested vaccine. The government gave the vaccine manufacturers immunity from liability, but created an alternative compensation program. Five thousand people sought benefits for vaccine injuries.
Today, untested vaccines with novel adjuvants that are likely to cause more autoimmune illness than occurred in 1976 will almost certainly be used. The manufacturers have been given liability, as have the government program planners. But no compensation mechanism has been created. And the public has not been informed.
Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W 207 288-5081 ext. 1220
C 207 522-5229
H 207 244-9165
pager 207 818-0708