U.S. Senators Mike Lee and Rand Paul have introduced the End the Vaccine Carveout Act, legislation aimed at stripping away special liability protections that shield vaccine manufacturers from civil lawsuits.
The House companion bill was introduced by Congressman Paul Gosar, signaling coordinated momentum in both chambers of Congress.
At the heart of the proposal is a challenge to longstanding federal policies that critics argue give pharmaceutical companies unique legal immunity — protections not granted to other drug manufacturers.
“Pharma giants are hiding behind legal protections to avoid being sued by Americans experiencing serious vaccine side effects,” Lee said. “Americans have a constitutional right to a trial by jury, but current laws allow Big Pharma players to dodge accountability and bar victims from pursuing their cases.”
Lee pointed to the COVID-era vaccine mandates that forced many Americans to choose between vaccination and their livelihoods.
“Many of these patients were forced to get vaccinated or lose their jobs during the pandemic and are now dealing with permanent and very serious complications,” he added. “Our bill will end these unconstitutional vaccine carveouts so that all Americans can receive the justice they deserve.”
Under current law, individuals who claim injury from vaccines must first file through the federal National Vaccine Injury Compensation Program (VICP) — a no-fault system created in 1986. Critics argue that the system limits damages, restricts legal discovery, and often leaves injured individuals without meaningful recourse.
Senator Paul did not mince words.
“If a drug hurts someone, you can sue the company in court,” Paul said. “But when it comes to vaccines, and in many cases the COVID vaccine, the rules are rigged: you’re funneled into a federal no-fault program that limits damages, restricts your options and — in many cases — leaves people without real justice. That’s cronyism.”
The proposed legislation would allow individuals who suffer vaccine-related injury or death to pursue direct civil action in state or federal court without being forced into the federal compensation program first.
The bill also targets the Public Readiness and Emergency Preparedness (PREP) Act, which granted sweeping liability protections during the COVID-19 public health emergency. Currently, COVID-19 vaccines remain classified as “covered countermeasures,” shielding manufacturers, distributors and administrators from most injury claims.
The End the Vaccine Carveout Act would remove COVID-19 vaccines from that protected category, effectively ending broad immunity even after the formal public health emergency has expired.
Representative Gosar framed the issue as one of fairness and equal treatment under the law.
“No product should be shielded from accountability simply because it is labeled a vaccine,” Gosar said. “Americans deserve equal protection under the law, full transparency and the right to seek justice when harmed. This legislation restores fairness, strengthens trust and puts patients — not special interests — first.”
Supporters argue the measure is about restoring constitutional rights and leveling the playing field between citizens and powerful corporations. Opponents are expected to argue that vaccine liability protections are necessary to ensure continued vaccine development and public health readiness.
The legislation sets up a renewed debate over the balance between public health policy and individual rights — and whether emergency-era protections should remain in place years after the pandemic.
For Lee, Paul and Gosar, the message is clear: the era of what they call “Big Pharma carveouts” must come to an end.
