COVID Vaccine Manufacturers Given Legal Immunity for Injuries or Deaths Caused by Fast-tracked Vaccines
In light of the COVID-19 pandemic, the United States and other countries around the globe have opened the door for accelerated development, testing and fast track licensure of experimental COVID-19 vaccines. The question many people have is: who will assume product liability when COVID-19 vaccines cause harm to an individual who has been vaccinated? AstraZeneca plc, a multinational pharmaceutical and biopharmaceutical company headquartered in Cambridge, England, has been granted product liability protection for the COVID-19 vaccine the company is developing by most countries with which it has made vaccine supply agreements. Liability questions have been a central issue in negotiations between AstraZeneca and countries seeking COVID-19 vaccine supply contracts. In the U.S., vaccine manufacturers are shielded from liability under the 2005 Public Readiness and Emergency Preparedness (PREP) Act if a vaccine or drug developed in response to a health emergency like a pandemic causes the death or permanent injury of an individual who receives it during pre-licensure clinical trials or after it is released for public use. The PREP Act was part of a series of “Bioshield” laws created in response to national security fears after 9/11 and subsequent reported weaponized microbe threats, which prompted Congress to encourage pharmaceutical companies to develop anti-bioterrorism vaccines by, in part, eliminating liability for injuries and deaths caused by those vaccines.