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U.S. Sen. Rand Paul (R) of Kentucky has introduced a bill that would repeal liability protections for vaccine manufacturers and allow for civil lawsuits against these companies.

The bill – S.3853 – titled “End the Vaccine Carveout Act” – was introduced February 11 and referred to the Senate Committee on Health, Education, Labor, and Pensions.

The proposed legislation would revise the Vaccine Injury Compensation Program (VICP), established by Congress in the 1980s, that assesses claims of vaccine injuries and deaths and, if approved, provides compensation.

If passed, Paul’s bill would amend the VICP to enable those who suffer vaccine-related injury or death to bypass a VICP claim and directly file a lawsuit against the vaccine manufacturer in state or federal court, according to The Defender.

Paul noted in a statement to The Defender that people who suffer harm from drugs have the ability to file a lawsuit against the drug company.

“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,” the senator said.

The bill is a companion to one introduced in the U.S. House in July 2025 by U.S. Rep. Paul Gosar (R-AZ).

The proposed legislation also would shred immunity protection for the developers and distributors of the COVID-19 vaccines, created under the Public Readiness and Emergency Preparedness (PREP) Act.

If signed into law, the legislation would exclude the COVID-19 vaccines from the definition of “covered countermeasures” under PREP, ending immunity from claims of injury for manufacturers and suppliers.

The Vaccine Safety Research Foundation (VSRF) called the bill’s introduction a “major breakthrough.”

“For 40 years, the 1986 National Childhood Vaccine Injury Act has acted as a fortress, protecting billion-dollar corporations from being held accountable for their products,” VSRF said in a statement posted to X. “This legal shield has stifled transparency and left countless families without a path to justice.”

“By dismantling this immunity, S. 3853 would return vaccine manufacturers to the same standard of accountability as every other industry in America,” the foundation continued. “No more ‘no-fault’ systems. No more special treatment. If a product causes harm, the manufacturer must answer for it in a court of law.”

“This bill is a massive step toward restoring scientific integrity and protecting the next generation,” VSRF concluded. “It’s time to put people over profits.”

U.S. Sen. Mike Lee (R-UT) is named as the only co-sponsor of the legislation thus far.

“Pharma giants are hiding behind legal protections to avoid being sued by Americans experiencing serious vaccine side effects,” Lee observed, according to The Defender. “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,” the senator explained. “Our bill will end these unconstitutional vaccine carveouts so that all Americans can receive the justice they deserve and hold Big Pharma accountable.”

Pediatrician Dr. Joel Gator also praised the legislation.

“For four decades, these companies have largely been protected from traditional lawsuits,” Gator posted to X. “Shouldn’t consumers have the same legal rights with vaccines as they do with every other product? And if you think ending liability would trigger a wave of lawsuits… doesn’t that raise bigger questions?”

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