Senators Paul, Lee Move to End Vaccine Maker Legal Shield

U.S. Senator Rand Paul (R-KY) has formally introduced S.3853, a bill to amend federal law and dismantle decades-old liability protections for vaccine manufacturers. The move signals a major shift in how Americans could seek justice for vaccine-related injuries.

Co-sponsored by Sen. Mike Lee of Utah, the legislation would amend the Public Health Service Act to “end the liability shield for vaccine manufacturers, and for other purposes.” The bill was formally introduced on February 11, 2026, and referred to the Senate Committee on Health, Education, Labor and Pensions.

Under current law, vaccine makers enjoy broad legal protections that largely bar civil lawsuits over alleged vaccine injuries. Many claims must instead go through the federal Vaccine Injury Compensation Program (VICP), a no-fault system created in the 1980s. The new legislation, often linked to the House’s End the Vaccine Carveout Act, would undo those protections and allow traditional civil litigation against manufacturers and administrators.

In announcing the bill, Sen. Paul strongly criticized the existing framework as unfair and tilted toward special interests. “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,” Paul said.

Sen. Lee echoed those concerns, calling the legal shield an affront to basic rights. “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 said. “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 proposed changes would also narrow other federal liability protections. The bill would exclude certain vaccines, including COVID-19 shots, from classification as “covered countermeasures” under the Public Readiness and Emergency Preparedness (PREP) Act, which has provided immunity from lawsuits during declared emergencies.

Supporters of the bill frame it as long-overdue accountability for powerful pharmaceutical companies. Rep. Paul Gosar (R-AZ), who introduced the companion House version of the End the Vaccine Carveout Act, H.R. 4668, said the legislation “restores fairness, strengthens trust, and puts patients — not special interests — first.”

"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.”

Public health and industry experts have warned that repealing liability protections could slow vaccine development and reduce access to vital immunizations. However, advocates for reform argue that current rules leave injured Americans without full legal recourse.

S.3853 represents one of the most aggressive Congressional attempts in years to reshape federal vaccine policy. Its progress through the Senate committee process will be closely watched by lawmakers, public health officials, advocacy groups and patients — especially those who have suffered vaccine-related injuries.

The full text of S.3853 is available HERE.