HHS extends COVID vaccine liability shield to Big Pharma for 5 years

With just over a month left to his term, outgoing Health and Human Services (HHS) Secretary Xavier Becerra has extended COVID-19 vaccine liability immunity to pharmaceutical companies for another five years.

Under the Public Readiness and Emergency Preparedness (PREP) Act, the HHS secretary can grant people and entities immunity from liability for injuries caused by their medical products during public health emergencies. Following the outbreak of the COVID-19 pandemic in 2020, then-HHS Secretary Alex Azar declared a public health emergency and granted immunity liability for COVID-19 products, which in February 2021 also came to include vaccines.

Two days before Joe Biden declared the end of the public health emergency on May 11, 2023, Secretary Becerra issued an official determination that a public health emergency continues to be a “credible risk.” That provided the justification to extend liability protection until December 31, 2024, even though there was no longer an actual emergency.

Last week, Becerra extended it again to December 31, 2029 providing the same reason.

“I have determined there is a credible risk that COVID-19 may in the future constitute such an emergency and am thus amending this Declaration to prepare for and mitigate that risk,” he wrote in a declaration.

“Development of and stockpiling vaccines, therapeutics, devices, and diagnostics for COVID-19 continues to be needed for U.S. preparedness against the credible threat of a public health emergency due to outbreaks of COVID-19,” he added.

The liability shield applies not only to vaccine manufacturers but also to distributors, pharmacists, hospitals, clinics, and anyone who administers the shots. It remains in effect whether or not an emergency is declared.

The Countermeasures Injury Compensation Program: A black hole

Since taxpayers injured by vaccines cannot sue the vaccine maker for damages, the federal government has established the Countermeasures Injury Compensation Program (CICP). The CICP is meant to compensate for injuries and deaths caused by medical devices and drugs delivered during certain public health emergencies, including COVID-19. The PREP Act declaration limits the compensation offered through CICP to serious injuries and death. 

However, the CICP has come to be known as a “black hole” as nearly all requests for vaccine injury compensation are denied. Prior to 2020, the CICP had adjudicated less than 500 cases in its entire history. In the last 15 years, there have been a total of 14,096 claims, with only 48 of them actually compensated — a rate of 0.34%. Claims due to injuries from the COVID-19 vaccine make up 96% of CICP claims, and only 18 have so far been compensated.

“At the current pace, it will take decades for the Countermeasures Injury Compensation Program — which prior to 2020 had decided fewer than 500 cases in its entire history — to sort through them all,” Reuters reported last year.