30 Lawmakers Sponsor Bill to End Liability Protection for Vaccine Makers

The End the Vaccine Carveout Act would end the broad protection from liability for injuries resulting from vaccines listed on the CDC’s Childhood Immunization Schedule.

by Brenda Baletti, Ph.D.

A bill introduced late last week in the U.S. House of Representatives would end the liability protections Congress gave vaccine makers under the 1986 Childhood Vaccine Injury Act.

Thirty Republican lawmakers signed on as co-sponsors to House Bill 9828, End the Vaccine Carveout Act. The proposed legislation would end the broad protection from liability for injuries resulting from vaccines listed on the Centers for Disease Control and Prevention’s (CDC) Childhood Immunization Schedule.

“The … vaccine makers are criminal enterprises that have paid tens of billions in criminal penalties over the past decade,” Children’s Health Defense (CHD) founder and chairman on leave Robert F. Kennedy Jr. said in a statement on the bill.

Kennedy, who has long advocated for eliminating liability protection for vaccine manufacturers, added, “By freeing them from liability for negligence, the 1986 statute removed any incentive for these companies to make safe products. If we want safe and effective vaccines we need to end the liability shield.”

CHD, React19 and The American Family Project also supported the development of the bill, the press release said.

REACT19 founder Brianne Dressen, who experienced a debilitating COVID-19 vaccine injury as a volunteer in AstraZeneca’s clinical trial, announced the bill and its co-sponsors in a post on X, formerly Twitter.

“People harmed are long overdue for a compensation process that actually works, and it’s time for the drug companies to pick up the tab,” she said.

‘Complex sham compensation program’ in place since 1986 act

Congress passed the 1986 National Childhood Vaccine Injury Act to address the risks of vaccines — which Congress and vaccine makers acknowledged had “unavoidable” side effects.

The act set up a “no-fault” system whereby instead of suing the manufacturers, people injured by vaccines can file a claim with the National Vaccine Injury Compensation Program (VICP), which adjudicates the claims.

The VICP was meant to insulate vaccine makers from lawsuits that could bankrupt them while ensuring that injury victims had a straightforward, non-adversarial and fair path to compensation.

The program is funded by a 75-cent-per-dose tax, paid by vaccine makers, for every vaccine included in the program.

The U.S. Department of Health and Human Services administers the VICP, also known as the “vaccine court.” Court-appointed “special masters” — typically lawyers who previously represented the U.S. government — manage and decide the individual claims.

The proceedings are more informal than a typical courtroom. There is no judge or jury, and the rules of evidence, civil procedure and discovery do not apply.

In practice, getting compensation through the VICP has been notoriously difficult. Critics say the program has devolved to protect government agencies and corporations rather than the health of vaccinated children.

CHD CEO Mary Holland said the 1986 Childhood Vaccine Injury Act effectively left parents and children injured by vaccines with no substantive way to get any compensation while giving vaccine makers a free pass.

“For over 35 years, parents of children injured and killed by government-recommended vaccines have been left with no meaningful redress — only a complex, sham compensation program that pits grieving families against the government, while Big Pharma enjoys no liability,” she said.

“During that same time, chronic health conditions in children — autism, ADHD [attention-deficit/hyperactivity disorder], severe allergies, asthma — have skyrocketed,” Holland said.

In some cases, people who are dissatisfied with the outcome of their case in the VICP, or who don’t get a timely decision, can sue the manufacturer for limited causes of action, such as fraud — as is the case in many of the over 200 gardasil injury lawsuits currently being argued against Merck in federal court.

Special protections for COVID drugmakers

Vaccines administered under emergency use authorization (EUA), such as the COVID-19 mRNA vaccines, aren’t covered by the VICP.

Instead, COVID-19 vaccine makers are protected from all liability by the Public Readiness and Emergency Preparedness (PREP) Act, which grants producers of vaccines, medications and medical devices total freedom from liability for any injuries arising from “countermeasures” used to address a public health or national security threat.

The PREP Act directs such “countermeasures” to be covered by the Countermeasures Injury Compensation Program (CICP).

While the FDA fully licensed versions of the Pfizer and Moderna COVID-19 vaccines for people ages 12 and up, it’s unclear if the fully licensed formulations are being administered, or if some people are still receiving EUA formulations.

COVID-19 vaccines for infants and children ages 6 months through age 11 have not yet been fully licensed — however, they were added to the childhood schedule.

Still, all COVID-19 vaccine injuries  — whether from a fully licensed or EUA formulation — remain covered only through the CICP.

However, for the tens of thousands of people injured by the COVID-19 vaccine, compensation through this program has proven nearly impossible.

To date, the CICP has paid only 16 claims for COVID-19 vaccine injuries, totaling $425,301.55. Except for one payment, all of the claims resulted in compensation of $8,962 or less.

The Pfizer (Comirnaty) and Moderna (Spikevax) COVID-19 vaccines for ages 12 and up were fully approved by the FDA, but people injured by those vaccines still must apply to the CICP program for compensation. No COVID-19 vaccines have been fully approved for children under 12. However, the CDC added the EUA COVID-19 shots, recommended for children ages 6 months through 11 years, to the childhood schedule. Children injured by unlicensed COVID-19 vaccines also are covered under the CICP — not the VICP.

During the pandemic, Pfizer and Moderna generated the largest profits in history for a drug from their COVID-19 mRNA vaccines. Pfizer made $37 billion in 2021, and slightly more in 2022 from the COVID-19 vaccine alone. Moderna generated over $18 billion in profits in 2021 and $19 billion in 2022.

The most current data from the Vaccine Adverse Event Reporting System (VAERS) show that between Dec. 14, 2020, and Aug. 30, 2024, a total of 1,602,516 total adverse events related to the COVID-19 vaccine were reported to VAERS, including 37,390 deaths. There were 311,544 serious injuries reported.

Research also shows that VAERS tends to provide an underestimation of vaccine injuries. Most people don’t report their vaccine injuries to VAERS. Research also has shown that many VAERS reports are delayed or deleted from public view for reasons that are not transparent.

Several lawsuits are currently challenging the constitutionality of the PREP Act, and others have made legal arguments that the PREP Act doesn’t apply in particular cases. However, recently many of these cases have been dismissed in state and federal courts.

Last week, after the Nevada Supreme Court dismissed a case against a hospital regarding a man injured by remdesivir, a drug covered by the Prep Act, Kim Mack Rosenberg, general counsel for CHD, told The Defender the decision highlighted “that we need legislative action to undo the damage created by acts such as PREP and the 1986 National Childhood Vaccine Injury Act.”

What the ‘urgently needed’ legislation will do

Holland said the End the Vaccine Carveout Act is “urgently needed”:

“This legislation will help end Big Pharma’s reign over government. The corrupt public-private partnership of the 1986 National Childhood Vaccine Injury Act has suppressed science, stacked the deck against families, subverted the democratic marketplace of checks and balances, and removed citizens’ rights to a trial by jury.

“Americans deserve better.”

The bill proposes to remove the requirement for vaccine-injured people to pursue compensation in the vaccine court. Under the law, someone injured by a vaccine would be able to pursue civil action against a vaccine maker, and to seek compensation through the VICP or both.

However, once a person is awarded compensation in civil court, they will no longer be eligible for compensation through the VICP.

The 1986 law also set a short statute of limitations for seeking injury compensation to two or three years of the death or injury, respectively. However, it often takes longer than that for people to realize that a vaccine caused their injury or illness.

The proposed law would allow anyone injured since the program became effective in 1988 to file a lawsuit.

Finally, the bill would end the protection from liability for the COVID-19 vaccines, allowing people injured by the vaccine to sue the vaccine makers in court.

“COVID-19 vaccines must be redefined as vaccines and not ‘countermeasures,’ so that the PREP Act’s liability carveout can no longer apply,” according to a white paper that provided justification for the bill.

The Defender on occasion posts content related to Children’s Health Defense’s nonprofit mission that features Mr. Kennedy’s views on the issues CHD and The Defender regularly cover. Mr. Kennedy, an independent candidate for president of the U.S., is on leave from CHD. In keeping with Federal Election Commission rules, this content does not represent an endorsement of Mr. Kennedy’s candidacy or his support for President Donald Trump’s campaign.