AstraZeneca and Emergent BioSolutions have struck an $87 million deal to manufacture two billion doses of the University of Oxford’s adenovirus-based COVID-19 vaccine to supply to the U.S. The manufacturing contract is part of the Operation Warp Speed initiative to develop and rapidly increase production of COVID-19 vaccines before the end of 2020 to make them quickly available to the U.S. population.4
The Secretary of HHS invoked the PREP Act following the Jan. 31, 2020 declaration of a COVID-19 pandemic public health emergency, stating that vaccines and drugs developed to respond to the coronavirus pandemic were covered countermeasures under the 2005 PREP Act.9
The PREP Act authorizes the Secretary of Health and Human Services (HHS) to provide liability immunity to “certain individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures, except for claims involving “willful misconduct” as defined in the PREP Act.10 11
Under the 2020 coronavirus pandemic public health emergency declaration, “covered persons”—which includes vaccine administrators and manufacturers—are generally immune from legal liability (i.e., they cannot be sued for money damages in civil court) for harm or losses relating to the administration or use of “covered countermeasures” (COVID-19 vaccines and drugs) before or after licensure.
The sole exception to immunity from civil liability under the PREP Act is for death or serious physical injury caused by “willful misconduct,” such as evidence of criminal fraud or gross negligence on the part of a company manufacturing the vaccine or a person who administered the vaccine.