Key Takeaways
- The federal PREP Act generally bars lawsuits against the makers, distributors, and administrators of covered COVID-19 vaccines, except in cases of willful misconduct, and HHS has extended that protection through December 31, 2029.
- People injured by a covered COVID-19 vaccine are generally limited to the federal Countermeasures Injury Compensation Program, which has a one-year filing deadline, a demanding proof standard, and a very low rate of paid claims.
- An employee injured by a vaccine their employer required for work may have a workers' compensation claim, depending on state law.
If you have a serious reaction to a COVID-19 vaccine, can you take the manufacturer to court? And could a business be sued for not requiring its employees to get vaccinated?
In this TalksOnLaw Brief, Joel Cohen talks with Professor Dorit Reiss, Professor of Law and the James Edgar Hervey ’50 Chair of Litigation at UC Law San Francisco (formerly UC Hastings), about liability and compensation when vaccines cause harm, and about the legal risks businesses face on both sides of the mandate question.
Why Most Vaccine Injury Lawsuits Are Barred
Reiss explains that a person who suffers a severe reaction to a COVID-19 vaccine generally cannot sue the manufacturers, distributors, or providers. That protection comes from the federal Public Readiness and Emergency Preparedness (PREP) Act, which shields covered countermeasures during declared emergencies. The Act contains a narrow exception for willful misconduct, which requires a demanding showing and a special federal court process.
The Countermeasures Injury Compensation Program
Instead of a lawsuit, the remedy is the Countermeasures Injury Compensation Program, or CICP, a government program that compensates certain injuries from emergency countermeasures, including vaccines. Reiss identifies three problems with relying on it. The evidentiary bar is high: claimants must show with compelling scientific and medical evidence that the countermeasure caused the harm, evidence that may not exist early on. There is only one year to file. And the CICP is a payer of last resort, so benefits are reduced by compensation available from other sources, such as health insurance.
Here, Reiss notes, mandates intersect with compensation. If an employer required the vaccine as a workplace measure and the employee was injured, the employee may be able to turn to workers' compensation, an easier system than the CICP.
Can Businesses Be Liable for Not Requiring Vaccines?
Reiss explains that there is a body of negligence law holding people liable for failing to prevent the spread of infectious disease, so a business that does not require vaccination could face claims if someone contracts COVID-19 on its premises. Two obstacles make such suits hard: tracing an infection to a particular business, and proving it was unreasonable not to mandate. A long-term care facility serving elderly, high-risk residents, with a large unvaccinated staff and an outbreak, would be in a weak position to defend itself; for most businesses, she says, such a claim would be hard to win, though hard cases have succeeded before.
What to Know Now
The framework Reiss describes remains in place. Although the federal public health emergency ended in May 2023, HHS amended its PREP Act declaration in December 2024 to extend liability protections for COVID-19 vaccines through December 31, 2029. Injury claims continue to go to the CICP, which has drawn criticism for its backlog and low payout rate: as of September 1, 2026, HRSA reported that 63 COVID-19 claims had been compensated out of 14,206 filed (11,145 of them alleging vaccine injuries), with 6,084 still pending. Advocates and some lawmakers have urged moving these claims to the National Vaccine Injury Compensation Program, which offers a court-based process; supporters of the current system emphasize that immunity encourages rapid production and distribution during emergencies.
The context around mandates has also shifted. Many employers dropped vaccine requirements after 2023, and several states, including Texas and Idaho, now restrict them, which affects both the workers' compensation route and any argument that failing to mandate was unreasonable. In August 2025, the FDA replaced the vaccines' emergency authorizations with approvals for narrower populations, a change that does not by itself remove PREP Act coverage.
