The Biden administration has extended liability protections for COVID-19 vaccine makers, health care providers, and others through 2029. The decision, which has sparked renewed debate over accountability for vaccine-related injuries and the future of public health policy, ensures immunity from most lawsuits for those involved in the development and distribution of COVID-19 vaccines and other medical countermeasures.
The five-year extension, signed by Health and Human Services (HHS) Secretary Xavier Becerra on Dec. 11, continues a policy first implemented during the pandemic under then-President Donald Trump. It is one of the longest liability protections in the history of the Public Readiness and Emergency Preparedness (PREP) Act. Proponents argue that the protections are essential for fostering innovation and maintaining public health readiness, but critics contend they leave vaccine-injured individuals without recourse and could limit future administrations’ ability to enact significant policy changes.
While the official COVID-19 public health emergency ended on May 11, 2023, the new declaration warns of a “credible risk of a future public health emergency.”
The PREP Act, enacted in 2005, grants liability immunity to encourage the swift development and deployment of medical countermeasures during public health emergencies. Without this protection, manufacturers and providers might hesitate to produce or distribute critical products—like vaccines or treatments—due to fears of lawsuits over unforeseen side effects. The act was first invoked for COVID-19 in March 2020, covering vaccines, antiviral treatments, diagnostic tools, and protective equipment.
As the United States prepares for potential future outbreaks, this latest extension ensures that legal protections for manufacturers and health care providers remain intact. However, the decision has sparked fresh calls for reform—or even repeal—of the PREP Act, with critics pushing for greater accountability and support for individuals harmed by medical countermeasures.
Broadening Scope of the PREP Act
Amendments to the PREP Act during the pandemic expanded its scope to include telehealth providers and pharmacy technicians,
thus speeding up the rollout of vaccines
in response to urgent health needs. According to the American Pharmacists Association, these changes improved access in underserved communities,
where local pharmacies often serve as primary health care providers. Nearly 90 percent of Americans live within five miles of a pharmacy. Previous amendments also supported health care providers in non-traditional settings, reflecting the shifting demands of public health emergencies.“Today’s necessary actions by HHS will continue to save lives and lower health care costs, particularly in rural and underserved areas where the local pharmacy may be the only health care provider for miles,” Michael D. Hogue, CEO of the American Pharmacists Association, said in a press release.
Continuing the PREP Act declaration for vaccines is a logical step, given that COVID-19 vaccines continue to evolve, according to Dr. Daniel Aaron, a law professor at the University of Utah. Vaccines often have limited long-term profitability compared to other pharmaceuticals, which can impact their development, Aaron told The Epoch Times in an email.
“The main idea here is that we may not want to impose liability on products essential for addressing current or future public health emergencies,” he said.
Concerns Over Broad Immunity
Proponents of the PREP Act argue it is essential for fostering innovation and protecting public health. Critics, however, contend that the law’s broad liability protections come at a significant cost—namely, lack of accountability for those harmed by vaccines or other medical countermeasures.
Attorney Aaron Siri, who has represented people injured by vaccines, argues that the PREP Act shifts the balance away from accountability.
“The PREP Act incentivizes development of products without concern on the manufacturers’ part of being held accountable for resulting harms,” he stated in an email to The Epoch Times. “Bringing a product to market that can cause more harm than good, and hence needs immunity to liability, is nonsensical.”
The extension of immunity protections has raised eyebrows, particularly in light of ongoing assurances about the safety of COVID-19 vaccines. “Since we have now been told, ad nauseum, for more than four years that COVID vaccines are safe, then why the need for continued immunity?” Siri asked.
Calls for sweeping reforms—or even the repeal—of the PREP Act have grown louder. On March 5, Rep. Chip Roy (R-Texas) introduced the Let Injured Americans Be Legally Empowered (LIABLE) Act, which would remove liability protections for COVID-19 vaccine manufacturers and allow individuals to sue companies like Pfizer and Moderna for vaccine-related injuries.
“Many have faced injury from the vaccine, but few have been afforded little recourse. To date, a mere 11 injury claims have been paid out despite nearly 700 million doses of the vaccine having been administered,” Roy said in a press release. “The American people deserve justice for the infringement on their personal medical freedom and those medically harmed deserve restitution.”
Siri agrees that the act no longer serves its intended purpose. “The PREP Act should be repealed in its entirety. It provides no value,” he said. He suggests fostering the development of medical products that are both effective and safe, eliminating the need for liability immunity.
Timing of the 12th Amendment Raises Questions
The extension is set to take effect on Jan. 1, 2025. The timing—just weeks before a presidential transition—ensures these protections will span the next administration and beyond, potentially limiting future policymakers’ flexibility.
The timing of the extension aligns with speculation about future leadership at the Department of Health and Human Services (HHS). Robert F. Kennedy Jr. has been nominated as HHS Secretary in the new administration. Kennedy’s long-standing calls for greater scrutiny of vaccine safety and reduced legal immunities for manufacturers could create tension with the protections solidified in the amendment.
By locking in liability protections until 2029, the amendment sets a public health framework that prioritizes stability during a time of political uncertainty while leaving little room for adjustment by future administrations. While any HHS secretary could theoretically modify or rescind these protections through additional amendments or declarations, the timing of the current extension may reduce flexibility for new leadership in the short term.
Systemic Failures in Vaccine Injury Compensation
The extension of liability protections under the PREP Act draws attention to persistent challenges in the U.S. vaccine injury compensation system, especially for people who have experienced adverse reactions to COVID-19 vaccines.
For Brianne Dressen, a Utah preschool teacher and clinical trial participant, the extended liability protections feel like a dismissal of the struggles those seeking justice and compensation face. Dressen, who suffered severe neurological complications after participating in AstraZeneca’s COVID-19 vaccine trial, has become a vocal advocate for vaccine-injured individuals.
“We have been begging HHS for years to help provide relief to those damaged by the COVID vaccines,” she told The Epoch Times in an email. “The message the current administration has sent is clear: ‘If you are harmed by a vaccine, we will not help you.’”
Becerra points to the Countermeasures Injury Compensation Program (CICP) as the primary pathway for addressing claims related to vaccine injuries. Established under the PREP Act, CICP was designed to address vaccine safety concerns by providing a pathway for people harmed by vaccines and other covered countermeasures.
However, critics claim the program falls short of its intended purpose. “The CICP is a ‘rigged system’ that leaves harmed individuals without adequate compensation,” Siri said.
Critics also point to low payout rates and a cumbersome filing process, making the program inaccessible to many.
As of Aug. 1, the Health Resources and Services Administration reported 10,226 claims pending or under review—a backlog that a recent House Select Subcommittee on the Coronavirus Pandemic report estimated could take nearly a decade to clear without major reforms. The report criticized the CICP for failing to handle the scale of the COVID-19 vaccination program.
Dressen’s organization, React19, supports people navigating these systemic challenges. She describes the current government programs as “smoke and mirrors,” adding, “Instead of protecting the consumer, HHS is committed to protecting the drug companies and corporate interests.”
According to React19, of the approximately 14,000 claims filed under the CICP, only 48 have resulted in compensation. The program has awarded less than $1 million in total. React19 asserts it can “support injured individuals far better than the government.”
HHS had not responded to The Epoch Times’ questions by the time of publication.
Balancing Preparedness and Accountability
The debate surrounding the PREP Act’s liability protections underscores the challenge of balancing public health preparedness with individual accountability.
Some lawmakers have proposed transitioning claims from the CICP to the more comprehensive National Vaccine Injury Compensation Program (VICP). Experts argue this shift could provide greater transparency, increased payouts, and a clearer legal framework for claimants. “The CICP has a more limited scope than the VICP and provides compensation only for ‘covered countermeasures,’ including vaccines,” wrote Rep. Brad Wenstrup of Ohio in the House Select Subcommittee on the Coronavirus Pandemic report.
Additionally, advocacy groups like React19 continue pushing for expanded government support for individuals harmed by COVID-19 vaccines, emphasizing the need for programs prioritizing fairness and accountability.
