Republicans Move to End Vaccine Makers’ Longstanding Legal Immunity

For 40 years, vaccine manufacturers have enjoyed immunity unmatched by any other industry. A new Senate bill aims to end that protection.

Republican lawmakers are moving to roll back decades-old legal protections for vaccine manufacturers, introducing legislation that would allow people injured by vaccines to sue drugmakers directly in court.

On Tuesday, Sens. Mike Lee (R-Utah) and Rand Paul (R-Ky.) unveiled the End the Vaccine Carveout Act, a Senate bill aimed at dismantling the unique liability shield vaccine makers have held since the mid-1980s.

If enacted, the bill would undo key provisions of the 1986 National Childhood Vaccine Injury Act, which largely bars lawsuits against vaccine manufacturers for injuries or deaths linked to vaccines recommended by the Centers for Disease Control and Prevention. Instead of going to court, injured individuals are required to seek compensation through a federal system known as the Vaccine Injury Compensation Program (VICP).

“The rules are rigged,” Sen. Paul said in a statement. “If a drug hurts someone, you can sue the company in court. But when it comes to vaccines—especially the COVID vaccine—you’re funneled into a federal program that limits damages, restricts your options, and often leaves people without real justice. That’s cronyism.”

The legislation would also strip COVID-19 vaccines of the sweeping liability protections they currently enjoy under the Public Readiness and Emergency Preparedness (PREP) Act. Congress passed the PREP Act in 2005 to shield pharmaceutical companies and healthcare providers from lawsuits related to “covered countermeasures” during declared public health emergencies.

During the COVID-19 pandemic, then–acting HHS Secretary Norris Cochran extended the PREP Act to cover COVID-19 vaccines, shielding manufacturers such as Pfizer and Moderna from liability. That liability shield was later renewed by former HHS Secretary Xavier Becerra in December 2024, extending it through 2029.

Under the PREP Act, people alleging injury from covered products such as COVID-19 shots must seek compensation through a separate federal program, the Countermeasures Injury Compensation Program (CICP). Critics say that the program, like the VICP, sets a high bar for compensation and rarely pays claims. As of February 1, 2026, the CICP has received 14,102 claims related to injuries from the COVID-19 shots. It has compensated only 44—about 0.3%.

If the End the Vaccine Carveout Act were to become law, COVID-19 vaccine claims would no longer be routed through the PREP Act system, and manufacturers could once again face lawsuits in state or federal court.

A companion bill was introduced in the House in July 2025 by Rep. Paul Gosar (R-Ariz.).

The original liability shield traces back to pressure from the pharmaceutical industry in the 1980s. At the time, vaccine makers faced a wave of lawsuits from families whose children were seriously injured by routine immunizations. Manufacturers including Merck, Lederle, and Wyeth (later acquired by Pfizer) warned Congress they would stop producing vaccines altogether unless granted legal protection—a threat lawmakers ultimately answered by passing the 1986 law.

Since then, the number of recommended childhood vaccines has risen sharply, from seven in the mid-1980s to more than 40, a trend critics cite as further reason to revisit the liability framework governing the vaccine industry.