The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The Act does not specify any criteria for determining the existence of an emergency. PREPA removes the right to a jury trial for persons injured by a covered vaccine, unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury. A notice was issued regarding Potential Eligibility for Compensation in December 2007, but it applies only to avian flu vaccine, and has not been funded.
CDC has asked its Advisory Committee on Immunization Practices to vote on recommending anthrax vaccine for civilian first responders (up to three million people) on October 22, 2008. The vaccine has only been used by the Defense Department in the past, under a mandatory and controversial program. DHHS announced another purchase of 14 million doses of anthrax vaccine on October 1, 2008, in addition to approximately 25 million doses already stockpiled.
DHHS issued a Declaration under the Public Readiness and Emergency Preparedness Act on October 1, 2008, declaring a public health emergency for anthrax. No discussion of why there is an emergency was provided. Not only did the declaration shield anthrax vaccine manufacturers and doctors who use the vaccine from liability for injuries that might arise: the declaration explicitly shielded "government program planners" who might recommend anthrax vaccine or other anthrax countermeasures.