U.S. Senator Mike Lee cosponsored the End the Vaccine Carveout Act with Senator Rand Paul (R-KY) to remove special liability protections that shield manufacturers and administrators from civil claims when Americans are harmed. Representative Paul Gosar, D.D.S. (AZ-09) introduced the House version of the bill.
“Pharma giants are hiding behind legal protections to avoid being sued by Americans experiencing serious vaccine side effects,” said Senator Mike Lee. “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. 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. Our bill will end these unconstitutional vaccine carveouts so that all Americans can receive the justice they deserve and hold Big Pharma accountable.”
“If a drug hurts someone, you can sue the company in court,” said Senator Rand Paul. “You can hold them responsible through the normal legal process. 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.”
“I strongly support the Senate companion legislation introduced by Senator Paul to my bill, the End the Vaccine Carveout Act,” said Representative Paul Gosar. “No product should be shielded from accountability simply because it is labeled a vaccine. 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.”
Background
Federal law grants vaccine manufacturers, including COVID-19 vaccine manufacturers, special legal protections not afforded to producers of other medical products from liability, even if their products cause injury or death. The End the Vaccine Carveout Act reforms the National Vaccine Injury Compensation Program (VICP) by allowing individuals who suffer vaccine-related injury or death to pursue direct civil action in state or federal court without first being forced into a federal no-fault system that limits recovery and restricts legal options. Under current law, injured individuals are generally required to file a petition through VICP before seeking judicial relief. This legislation removes those barriers, as well as the current immunity shield for COVID-19 vaccines pursuant to the Public Readiness and Emergency Preparedness Act.
The End the Vaccine Carveout Act also amends the Public Readiness and Emergency Preparedness (PREP) Act by excluding COVID-19 vaccines from the definition of “covered countermeasures.” This change ends the broad immunity currently shielding manufacturers, distributors, and administrators from most COVID-19 vaccine injury claims, even years after the public health emergency has ended.
Read the full text of the bill here.

