1. The US government is using laws designed for dealing with a very deadly pandemic, or bioterrorism, to bring about a mass vaccination program for swine flu, beginning with the Public Readiness and Emergency Preparedness Act 0f 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 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 (enacted in Section 564 of the Federal Food, Drug, and Cosmetic Act, amended by the Project BioShield Act of 2004) in response to requests from the CDC to make available certain drugs (Tamiflu and Relenza), 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 for comments to FDA on carcinogenicity testing by Dr. Novicki, 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 with vaccines in a hurry, yielding a potential Perfect Storm.
In the 1976 swine flu vaccine program, 45 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. Four hundred twenty seven developed the autoimmune, paralytic illness Guillain-Barre Syndrome. Over thirty of them died.
Experts have suggested that in the absence of prelicensure clinical trial data, it will be important to perform postmarketing surveillance to learn about the side effects from swine flu vaccines. According to Reuters, "the FDA's Dr. Hector Izurieta said the agency had set up an exceptionally extensive network for what is known as post-marketing surveillance."
Postmarketing surveillance may be sufficient to identify severe side effects when new drugs are marketed, as they only gradually come to be used by large numbers of patients. But for a vaccine that will be employed in a mass inoculation campaign, targeted at half or more of the US population, tens (or hundreds) of millions will be vaccinated in a few weeks, before sufficient time has elapsed to learn about the adverse effects.
Untested swine flu vaccines employing novel adjuvants, which are likely to cause more autoimmune illness than occurred in 1976, will almost certainly be used. The manufacturers have been given liability protection, as have the government program planners. Efficacy and safety are unknown. But no compensation mechanism has been created. And the public has not been informed.