Efforts are underway on Capitol Hill and in the Trump administration that raise the possibility of repealing the National Childhood Vaccine Injury Act of 1986 (NCVIA), a public law that established a “no-fault” system to settle claims over vaccine injuries or deaths.
In recent months, proposed legislation such as the End the Vaccine Carveout Act, the PREP Repeal Act, and the reinstatement of the Task Force on Safer Childhood Vaccines within the Department of Health and Human Services have signaled a potential end to vaccine manufacturers’ liability protections. Efforts face strong headwinds from drug makers and some medical associations, who have long been successful in deflecting vaccine safety and efficacy concerns.
Crossroads
Peter McCullough, M.D., a cardiologist, epidemiologist, and world-renowned vaccine critic, and Health and Human Services Secretary Robert F. Kennedy, Jr., have blamed the Act for scant regard for vaccine efficacy and safety, especially after the rollout of the COVID-19 shots after limited clinical trials.
“For the safety of American children, the Act should be repealed,” McCullough told Health Care News.
Passed in 1986 by Congress and President Ronald Reagan, the Act was a result of vaccine makers’ successful lobbying to install liability protections for their products. At the time, costly vaccine injury lawsuits were mounting from effects of the 1948 DPT (Diphtheria, Pertussis, Tetanus) combination shot, in which aluminum adjuvants were used to incorporate a whole-cell vaccine for pertussis.
Drug makers claimed the lawsuits were overwhelming drug production.
Some countries developed an alternative to the pertussis vaccine. The response in the United States was to shield drug makers from debilitating lawsuits. Not only did the NCVIA limit liability for vaccines already on the market, but it also protected shots developed in the future, as long as they achieved ‘recommended routine use’ status by the U.S. Centers for Disease Control and Prevention (CDC).
Captive Market
“As a result, almost every routine childhood vaccine the CDC recommended 39 years later was licensed without a placebo control group; often had too few participants to detect safety signals; and was frequently monitored for safety post-injection for only days or weeks,” said Allison Lucas, policy director at Citizens’ Council for Health Freedom.
Over time, the CDC’s childhood vaccine schedule grew from three shots to 18, significantly higher than most developed nations. States use the schedule to mandate vaccines for children in public settings, like schools and daycare centers.
Investment in vaccine development became a winning prospect for drug makers, says Lucas.
“In short, Congress removed liability for harm, giving vaccine manufacturers little reason to create safer or more effective vaccines…curating a captive, injectable, and lucrative market for vaccine manufacturers,” said Lucas.
Lawsuits Barely Worth It
The NCVIA established the National Vaccine Injury Compensation Program (VCIP), a “no-fault” system to award people for vaccine injuries or death without litigation.
“The VCIP is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions,” states a Health Resources & Services Administration (HRSA) fact sheet.
But the VCIP has done little to improve vaccine safety, says Lucas. “The program is riddled with conflicts of interest and barriers, and it provides minimal payouts to the vast majority of the vaccine-injured,” said Lucas.
The VCIP has paid out more than $4.9 billion between 1988 and 2022, but that may be an understatement, says Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
“It was supposed to be quick compensation for anything in the vaccine injury table, but the government fights most cases, the statute of limitations is very short, and probably only a small percentage of injuries are compensated, and at that, very inadequately,” said Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
Awards are paid out through a vaccine fund supported by an excise tax imposed on each vaccine dose.
Informed Consent Problems
The NCVIA also interferes with the ethical practice of medicine, says Michelle Cretella, M.D. the past Executive Director of the American College of Pediatricians (ACPeds).
“The Act hinders fully informed consent and limits a physician’s ability to prioritize individual patient needs over federal mandates,” said Cretella.
Doctors are under pressure to administer shots, and performance may impact compensation. Medicaid and the Children’s Health Improvement Program (CHIP) required medical practices to report vaccine compliance until the Centers for Medicare and Medicaid Services (CMS) overturned that requirement on December 30. 2025.
Financial incentives, liability protection, and mandatory vaccination reporting have led to harmful vaccine products, says McCullough.
“In the United States, the most widely used MMR (Mumps, Measles, Rubella) vaccine…was released on the U.S. market in 1978,” said McCullough. “Encephalitis, brain inflammation that can lead to seizures and neurological impairment, is mentioned in the package insert under adverse reactions, [but] with no impetus to improve the vaccine in terms of neurological safety, the public is put at continued risk.”
Action Underway
Until Congress passes legislation limiting or eliminating vaccine liability protection, the Trump administration is taking matters into its own hands. Last year, Kennedy reinstated a vaccine safety review task force. On January 5, HHS announced a drastic reduction in the recommended vaccines for children.
Cretella says repeal of the 1986 Act is a “distinct possibility,” given the administration’s focus on childhood vaccines. “A repeal should be welcomed by all ethical and critically thinking Americans,” said Cretella.
Lucas and Orient say they are not so optimistic.
“I think the more likely outcome is that HHS, under Kennedy’s leadership, will continue to update CDC guidance for routinely recommended vaccines, which may provide an opportunity for the vaccine-injured to file lawsuits outside of the VCIP,” said Lucas.
“Given the enormous power of Big Pharma, repeal is very unlikely,” said Orient. “Consider the fact that the COVID vaccines are still promoted despite overwhelming evidence of harm.”
Ashley Bateman ([email protected]) writes from Virginia.
