Sen. Rand Paul, (KY-R) introduced legislation titled “A bill to amend the Public Health Service Act to end the liability shield for vaccine manufacturers, and for other purposes.”
Although the full text has yet to be made available, news outlets, and commentators, as well as analysts and advocates contacted by Health Care News, infer that it is an attempt to undo the liability protections that vaccine manufacturers received under the 1986 National Childhood Vaccine Injury Act.
Introduced by Paul, a physician, on February 11 and co-sponsored by Sen. Mike Lee (R-UT), the bill has been referred to the Committee on Health, Education, Labor, and Pensions.
Latest Vaccine Reform Effort
Paul’s bill is the latest in a series of efforts at the federal and state levels concerning U.S. vaccine policy and practices.
As previously reported by Health Care News, the Centers for Disease Control and Prevention (CDC) updated its recommendations regarding childhood vaccinations following an assessment that found the United States to be an outlier among developed nations in the number of diseases and the number of vaccine doses recommended by its childhood vaccine schedule.
Additionally, some states, such as Florida and Idaho, have recently moved to ban vaccine mandates.
Long Overdue Effort
Critics of the liability protections enjoyed by pharmaceutical manufacturers suggest the kind of reform Paul’s bill could bring is long overdue.
“It is admitted that vaccines have adverse effects, hence the vaccine injury compensation program, which is grossly inadequate,” said Jane Orient, M.D., the executive director of the Association of American Physicians and Surgeons.
Yet, despite the high medical expenses that can result from vaccine injuries, most families have “no chance” of compensation because of an “extremely short” statute of limitations and a lack of knowledge of their options, says Orient.
Improving Vaccine Safety
“This bill provides the essential stimulus for vaccine manufacturers to constantly improve their products and make them safer for children,” said Peter A. McCullough, M.D., the President of the McCullough Foundation, and co-author of the organization’s 2025 report regarding the determinants of autism.
“Some vaccines have not been updated for decades and carry warnings for brain inflammation or encephalitis, which can lead to ADHD, autism, tics, and seizures,” said McCullough. “Americans should not tolerate an older, toxic product(s) when better ones can be developed.”
Similar sentiments were expressed by Orient regarding how the bill could affect vaccine safety.
“If passed, I think some manufacturers would stop making the most dangerous vaccines,” said Orient. “This almost happened with pertussis before the liability shield was passed. It should happen immediately for COVID mRNA vaccines.”
This could entail removing potentially dozens of vaccines from the market, says McCullough, later adding, “companies would not risk the court system and expensive verdicts which could bankrupt them.”
More stringent requirements for warnings and informed consent would also likely follow, says Orient.
Balancing Accountability and Public Goods
Paul’s proposed legislation, however, could negatively affect public health, destabilize the vaccine supply, and halt future vaccine development, says Jeffrey Singer, M.D., a senior fellow at the Cato Institute.
“This is one of those areas where libertarians are not of one mind,” said Singer. “On the one hand, I share the concerns of people like Sen. Rand Paul that liability immunity can undermine tort accountability and distort risk pricing. On the other hand, vaccines function a bit like public goods—they create herd-immunity benefits that extend beyond the individual, and that markets don’t fully capture.”
“[T]he liability wave of the 1980s, fueled by courts wrestling with complex science, was already pushing manufacturers out,” said Singer. “The National Childhood Vaccine Injury Act was Congress’s response. I worry that if immunity is removed, a new wave of liability lawsuits could follow, vaccine manufacturers may exit the market, and new vaccine development could be hindered. I, therefore, see immunity combined with no-fault compensation as a second-best compromise—one that helps stabilize vaccine supply while still compensating the injured.”
Unlikely to Become Law
As for the ultimate prospects of the bill becoming law, both Orient and McCullough, despite their support for it, expressed doubts.
“This bill has a very low chance of passing because of the powerful vaccine lobby,” said McCullough. “This is not only a $100B annual business, but our government purchases at least half of the products, making the liability chain entangled.”
Likewise, said Orient. “I think the chances of it becoming law are close to zero, but simply proposing it is very worthwhile,” adding, “the manufacturers should not have this unique shield against product liability…” s
Those who want to see change to vaccine policies should not focus solely on the manufacturers, says Orient.
“[W]e should also discuss the responsibility of medical associations and public health departments, who cover for them and support mandates,” Orient said.
Daniel Nuccio, Ph.D. ([email protected]) is a spring 2026 College Fix journalism fellow, reporter, and editorial associate for Health Care News.
