The Biden administration has extended liability protections for COVID-19 vaccine manufacturers, health care providers, and others under the Public Readiness and Emergency Preparedness (PREP) Act through 2029. The decision, signed by Health and Human Services (HHS) Secretary Xavier Becerra on December 11, continues a policy that began under former President Donald Trump to shield those involved in the development and distribution of COVID-19 vaccines and medical countermeasures from most lawsuits.
This five-year extension is one of the longest liability protections ever implemented under the PREP Act, sparking renewed debate over accountability for vaccine-related injuries. Proponents say the protections encourage innovation and maintain public health readiness, but critics argue they deny recourse for those harmed by vaccines.
Though the COVID-19 public health emergency ended on May 11, 2023, the declaration notes a “credible risk of a future public health emergency.”
Expansion of the PREP Act
The PREP Act, enacted in 2005, provides liability immunity during public health emergencies to facilitate the swift development and deployment of medical solutions without fear of lawsuits. It covers vaccines, treatments, diagnostic tools, and protective equipment. The act was first invoked for COVID-19 in March 2020.
Amendments during the pandemic expanded its scope, including protections for pharmacy technicians and telehealth providers. These changes helped deliver vaccines to underserved areas where pharmacies often serve as the main health care provider. “Today’s necessary actions by HHS will continue to save lives and lower health care costs, particularly in rural and underserved areas,” said Michael D. Hogue, CEO of the American Pharmacists Association.
Dr. Daniel Aaron, a law professor at the University of Utah, highlighted the ongoing role of liability protections for fostering the development of vaccines, stating, “The main idea here is that we may not want to impose liability on products essential for addressing current or future public health emergencies.”
Concerns Over Broad Protections
Critics argue that liability immunity prioritizes manufacturers over individuals who suffer vaccine-related injuries. Attorney Aaron Siri, who represents vaccine-injured clients, claims the PREP Act removes incentives for companies to ensure product safety.
“The PREP Act incentivizes development of products without concern on the manufacturers’ part of being held accountable for resulting harms,” Siri said. “Bringing a product to market that can cause more harm than good, and hence needs immunity to liability, is nonsensical.”
The extension has also raised questions about the continued need for such protections. “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 Reform
The liability protections have fueled demands for legislative reform. 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 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. “The American people deserve justice for the infringement on their personal medical freedom, and those medically harmed deserve restitution.”
Siri echoed calls for repeal, stating, “The PREP Act should be repealed in its entirety. It provides no value.”
Questions Surrounding the Timing
The protections are scheduled to take effect on January 1, 2025—weeks before a potential change in presidential administration. This timing ensures that liability shields remain intact for years, potentially limiting the ability of new leadership to make changes. Critics note that future leadership at HHS could face hurdles to modifying the current framework.
Vaccine Injury Compensation Challenges
The extension has also renewed scrutiny of the Countermeasures Injury Compensation Program (CICP), which is supposed to address claims from individuals harmed by vaccines. The program, established under the PREP Act, has been widely criticized for its limited payouts and lack of accessibility.
Brianne Dressen, a clinical trial participant who suffered severe neurological complications from AstraZeneca’s COVID-19 vaccine, said the extended liability protections highlight systemic failures in addressing vaccine-related injuries. “We have been begging HHS for years to help provide relief to those damaged by the COVID vaccines,” she said. “The message the current administration has sent is clear: ‘If you are harmed by a vaccine, we will not help you.’”
Critics point out that only 48 claims out of 14,000 filed under the CICP have been compensated, totaling less than $1 million in payouts. React19, a group supporting vaccine-injured individuals, argues the CICP is “rigged” and fails to provide meaningful relief.
HHS has promoted the CICP as a solution, but lawmakers like Rep. Brad Wenstrup (R-Ohio) have suggested transitioning claims to the National Vaccine Injury Compensation Program (VICP), which offers higher payouts and increased transparency.
Balancing Preparedness and Accountability
The extension of the PREP Act protections through 2029 underscores the ongoing struggle to balance public health preparedness with accountability for injuries. While supporters stress the importance of shielding manufacturers to encourage innovation, critics argue for reform and greater recourse for affected individuals.
As debate intensifies, advocates like Dressen and groups like React19 continue pushing for reforms that prioritize both public health readiness and the rights of individuals harmed by vaccines.
