Department of Health and Human Services Secretary Kathleen Sibelius has not only given immunity to the makers of Tamiflu and Relenza for injuries stemming from their use against swine flu, she has granted immunity to future swine flu vaccines and “any associated adjuvants”.
The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time around, they will have no recourse.
The 2006 Public Readiness and Emergency Preparedness Act (the PREP Act) allows the DHHS Secretary to invoke almost complete immunity from liability for manufacturers of vaccines and drugs used to combat a declared public health emergency.
The PREP Act removes the right to a trial jury unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury -- and gets permission to sue from the DHHS Secretary.
But once the PREP Act is invoked to shield manufacturers from liability, the pharmaceutical firms have no financial incentive to make the safest product, and have a negative incentive to test it for safety. As long as they do not deliberately harm consumers of the product, they will not be liable for damages.
Meanwhile, while the U.S. Centers for Disease Control and Prevention hoping to have 120 million doses of H1N1 swine flu virus vaccine ready before flu season this fall, some are raising concerns over what they see as an effort to rush the drug through safety trials.
The source of many of these concerns is the probability that the mercury-containing preservative thimerosal will be an ingredient in some of the doses of the new vaccine.
Groups opposed to current vaccination practices condemn thimerosal as a toxin responsible for the development of autism and related ailments in children. Additionally, the possibility that the swine flu vaccine could also contain an adjuvant, an ingredient that would allow more doses to be created from existing supplies of the vaccine, has also worried these groups.