Senator Rand Paul (R-KY) introduced S.3853, “End the Vaccine Carveout Act” on February 17, 2026 with cosponsor Senator Mike Lee (R-UT). S.3853 was introduced as a companion bill to H.R.4668 introduced in the House by Representative Paul Gosar (R-AZ) on July, 2025. Representative Gosar had introduced the bill originally in 2024. 

The bills, if signed into law, would lift the current liability shield for vaccine manufacturers and allow people injured by vaccines to sue directly in state or federal court instead of filing a petition through the National Vaccine Injury Compensation Program (VICP). The bills would also lift the liability shield for COVID-19 vaccines.  Representative Paul Gosar welcomed Senator Rand Paul’s bill, stating: “I strongly support the Senate companion legislation introduced by Senator Paul to my bill, the End the Vaccine Carveout Act. 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.”

The 1986 Act gave a liability shield to vaccine makers

The 1986 National Childhood Vaccine Injury Act which gave a liability shield to vaccine manufacturers was a compromise made after vaccine manufacturers threatened Congress that they would no longer make vaccines if they were not given immunity from lawsuit.  In the 1980s, there was a rash of lawsuits against these companies because of the injuries suffered by children especially from the DTP (Diphtheria, Tetanus, and Pertussis) vaccine. What the vaccine companies got from the “compromise” law was immunity from lawsuit under most cases. Instead of suing the manufacturer of the product, and the vaccine injured or killed someone, the person or the family is required to petition the National Vaccine Injury Compensation Program (VICP). VICP is a no-fault government program that provides limited compensation for vaccine harms and often does not provide justice for the injured. It is notorious for its refusal to recognize autism as a potential vaccine injury.

The 1986 Act directed HHS to show increased vaccine safety

What the people got from the “compromise“ was assurances written into law that vaccines would be made more safe, as the law required that the Secretary of Health and Human Services (HHS) take recommendations from a task force and then prepare and submit reports to Congress on what has been done to assure the safety of vaccines. The first report was due in 1988, two years after the Act became law, and HHS was to submit regular reports after that. No report has yet been submitted in close to 40 years. 

HHS never followed the 1986 Act to make vaccines safer

In response to a FOIA from the non-profit Informed Consent Action Network, HHS admitted in 2018 that the task force that was to report on the assurances of vaccine safety had been disbanded in 1998, and that no reports had been filed with Congress.  In 2023, HHS agreed that there was still no task force and no reports filed. Finally, under HHS Secretary RFK, Jr., the task force was reinstated in August 2025 and it looks likely that there will finally be a report. This report should show how HHS has directed development of vaccines with fewer adverse reactions and how improvements have been made in various areas like licensing, manufacturing, testing, labeling, adverse reaction reporting, surveillance, and research, to reduce risks of adverse reactions.

More childhood vaccines and poor-quality safety testing

The 1986 Act liability shield has allowed vaccine companies to produce a medical product where they are not financially responsible for harm, which has been an extremely lucrative situation for these manufacturers. The vaccine companies have taken advantage of this situation and the number of vaccines for children has surged from 12 shots by age 18 in 1986 to 54 shots in 2019 and many more by 2025. This has occurred while vaccine companies do not do adequate safety testing against inert placebos for vaccines on the childhood schedule. 

The PREP Act liability shield for COVID-19 vaccines

During public health emergencies, liability shields were also provided for vaccine makers if the emergency was declared under the Public Readiness and Emergency Preparedness (PREP) Act. The Countermeasures Injury Compensation Program (CICP) provides the liability shield for vaccine makers. Instead of lawsuits for faulty injurious products directly to the manufacturer, the injured person or family must petition CICP for compensation. These lawsuits are again limited like those under VICP and many injured people are never compensated. For example, the petitioner must file paperwork to show the injury within one year from the time that the COVID-19 vaccine was given, and if the injury is not one listed on the “table” of injuries, then the individual must prove that the injury is the direct result of the vaccine. Compensation is limited and there is no judicial review.

Beacon of hope

These bills are a beacon of hope to Americans who expect product manufacturers to be held accountable for the safety of their products and to the thousands of families terribly impacted by the liability shield. The bills will lift the current liability shield and allow people injured by vaccines to sue directly in state or federal court instead of filing a petition through the National Vaccine Injury Compensation Program (VICP). The bills would also lift the liability shield for COVID-19 vaccines.