COVID: Pfizer, Moderna, and Other Vaccine Makers Get Legal Immunity for Some Time

Posted on 01/15/2021

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:

of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
determined by the Secretary to constitute a present, or credible risk of a future public health emergency
to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures
A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.

Source: U.S. Department of Health and Human Services.

In February 2020, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act a 2005 law. The legal protection lasts until 2024.

World governments are coordinating to get the coronavirus vaccines to as many people as possible. People who take the COVID vaccines and experience side effects won’t be able to sue Pfizer or Moderna, and likely the U.S. government will not compensate you for damages. Under the PREP Act, pharma giants like Pfizer and Moderna have total immunity from liability in the case if something unintentionally goes wrong with their approved vaccines.

The Trade Off

Pharmaceutical companies typically aren’t offered much liability protection under U.S. law; but in circumstances of a pandemic, the U.S. government needed to assure pharma companies of blanket immunity law to get a vaccine out and widely distributed. Furthermore, if there was legal risk for the pharma companies for the COVID vaccine, the company would increase the cost of the vaccine to build-in legal risk.

Get News, People, and Transactions, Delivered to Your Inbox