The U.S. Department of Health and Human Services (HHS) has extended sweeping liability protections for COVID-19 vaccine manufacturers and administrators until Dec. 31, 2029. This decision, which takes effect on Jan. 1, 2025, marks the 12th consecutive extension of the controversial liability shield established under the Public Readiness and Emergency Preparedness Act (PREP Act).
HHS Secretary Xavier Becerra defended the move, claiming COVID-19 still poses a “credible risk” to public health.
“I have determined that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease COVID-19 constitutes a credible risk of a future public health emergency,” Becerra stated, citing the need for ongoing vaccine development and stockpiling.
However, critics argue the real motive behind the extension is to protect pharmaceutical giants and shield government agencies from accountability for their actions during the pandemic.
Kim Mack Rosenberg, general counsel for Children’s Health Defense (CHD), called the extension a blatant attempt to prioritize industry interests over public safety.
“This is very concerning because it protects industry and the government while allowing for largely unchecked product development,” Rosenberg said.
The PREP Act, enacted in 2005, provides legal immunity to manufacturers, distributors, and administrators of countermeasures like vaccines, even if those products cause harm. Although the Biden administration declared the COVID-19 public health emergency over in May 2023, the PREP Act’s emergency powers remain intact, enabling the government to extend liability protections at will.
The decision comes amid mounting concerns about vaccine safety and growing calls to pause or even remove COVID-19 vaccines from the market due to reports of deaths and injuries. Dr. Joel Wallskog, a Wisconsin orthopedic surgeon who was injured by Moderna’s COVID-19 vaccine, expressed his disappointment:
“This decision has nothing to do with a COVID-19 ‘threat.’ It’s purely to protect themselves from litigation and to prevent Americans injured by the vaccines from receiving fair compensation,” Wallskog said.
Dr. Danice Hertz, a retired gastroenterologist injured by the vaccine, called the move “inappropriate and unethical,” accusing HHS of exploiting vague future threats to justify continuing protections for “potentially dangerous” medical products.
Liability Protections Leave Victims Without Recourse
One of the most contentious aspects of the PREP Act is its shielding of vaccine manufacturers from lawsuits, leaving injured individuals to seek compensation through the Countermeasures Injury Compensation Program (CICP). This system has been widely criticized for its poor performance:
- Out of 13,520 COVID-19-related claims filed, only 18 have been compensated as of Nov. 1, 2024.
- The average payout is a paltry $24,513.93, with most claims receiving far less.
Dr. Wallskog highlighted the program’s 98% rejection rate, describing it as a “dismal failure.”
“The only emergency being extended here is the crisis of vaccine injuries plaguing Americans,” he added.
Legislation to Overhaul Vaccine Injury Program Stalled
Efforts to address vaccine injury compensation issues, such as the “Let Injured Americans Be Legally Empowered Act” (LIABLE Act), have stalled in Congress. If passed, the bill would allow vaccine injury victims to sue manufacturers directly. However, critics argue Congress lacks the political will to challenge Big Pharma.
“There is no credible threat to justify this extension. This is about politics and protecting the profits of pharmaceutical companies, plain and simple,” Wayne Rohde, author of The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program, said.
With the Biden administration nearing its end, questions remain about whether the incoming government will rescind these protections. President-elect Donald Trump has nominated Robert F. Kennedy Jr., a vocal critic of vaccine policies, to lead HHS. Kennedy’s confirmation could signal a shift in how vaccine injury claims are handled.
“This is about ensuring that manufacturers stay protected at all costs, even at the expense of the American public. The only thing the PREP Act guarantees is more victims with no recourse,” said Ray Flores, outside counsel for CHD.
With lawsuits challenging the PREP Act now underway in states like Vermont, North Carolina, and Utah, the fight for accountability is far from over. As Flores noted, “It’s time to dismantle this shield and put public safety back at the forefront.”
