The determination is dated June 30, 2026. On that day Robert F. Kennedy Jr. signed two orders terminating the COVID-19 emergency use authorization declarations, the instruments that let the FDA clear vaccines and treatments for emergency use before or outside full approval. The device declarations wind down in 180 days, by December 26, 2026; the drug and biologics declarations run twelve months, to June 29, 2027. Market access for these products now has an end date. The right to sue the companies that made them does not. That authority lives in a second document, written under a different law, and Kennedy left it untouched.
Two instruments, two statutes. The market-access authority comes from Section 564 of the Food, Drug, and Cosmetic Act, the EUA declaration Kennedy just terminated. The liability shield comes from a separate declaration under the Public Readiness and Emergency Preparedness Act, the PREP Act, signed and repeatedly amended since March 2020. Ending one leaves the other standing. In December 2024, outgoing Secretary Xavier Becerra signed the 12th Amendment to the COVID countermeasures declaration, extending its liability protections through December 31, 2029. Kennedy has not amended it. He has not rescinded it. He signed the paper next to it.
Here is what that shield does, in the language of the statute. It grants immunity from suit to manufacturers, distributors, and the pharmacies and clinics that administered the shots, against nearly any claim of injury arising out of the administration or use of a covered countermeasure. Congress left one door open and made it narrow: an exclusive federal cause of action for death or serious physical injury proximately caused by willful misconduct. Ordinary negligence does not qualify. A design defect does not qualify. A claimant has to prove a covered person acted with deliberate intent to cause harm, in a single federal venue, a standard so steep that in practice it leaves the courthouse closed.
Follow that asymmetry to its edge. The same manufacturers this declaration protects from injured patients are, in these same years, answerable to a different kind of plaintiff in open federal court. Investors in Emergent BioSolutions, the contractor whose Baltimore plant ruined millions of vaccine doses, brought a securities-fraud action in Maryland. Shareholders in Novavax sued the company in the same district, alleging they were misled about its vaccine timeline. Those cases reached a federal judge. A person who says the product itself injured them cannot open that door at all, not under the declaration Kennedy left in place. The shareholder who lost money gets the court. The patient who lost their health gets a claims window.
That window has a name most Americans have never heard: the Countermeasures Injury Compensation Program, run by the Health Resources and Services Administration. Its record is public. As of the agency’s June 2026 data, 14,152 COVID countermeasure claims had been filed, 11,055 of them alleging vaccine injury or death. The program had rendered 7,407 decisions. It found 95 of the vaccine claims eligible for compensation, 0.9 percent. Of the claims it has actually decided, it denied more than 98 percent. Roughly 6,700 still sit undecided, some filed years ago.
Compare the program Congress built for childhood vaccines. The Vaccine Injury Compensation Program pays claimants’ legal fees, compensates pain and suffering, and lets a special master weigh the evidence. The countermeasures program does none of that. It pays no attorney fees, compensates no pain and suffering, makes claimants spend their own health insurance first, imposes a one-year filing deadline, and offers no appeal to a court. One is a courthouse. The other is a claims window with the shutters mostly down.
The record makes one more thing hard to set aside. Kennedy built much of his public career on this exact shield. As a candidate and again as a nominee, he named the liability protections as the reason manufacturers have no incentive to make safer products, and said he meant to go after them. Ending the EUA declarations, he said in the HHS announcement, reinforces “public confidence that emergency authorities are temporary and targeted.” The PREP Act hands the Secretary the power to amend or rescind the countermeasures declaration by signature. He holds that pen now. At the end of June he used it on the market-access paperwork and left the immunity Becerra stretched to 2029 sitting where it was.
The documents do not prove that any single shot caused any single injury. The compensation program turns on exactly that question, claim by claim, and almost always answers it against the claimant. Nor do they prove Kennedy will never move on the declaration; the 2029 date is a ceiling, not a floor, and the pen that set it can strike it early. What the record does show is the gap between a Secretary who spent years calling this shield the core of the problem and a signature, in June, that ended the paperwork beside it and left the shield alone.
The EUA determinations are signed and dated. The PREP Act declaration sits on the same Secretary’s desk, revocable by the same hand, and it runs to December 31, 2029 unless he moves it. He has not moved it. Until he does, the roughly 6,700 people still waiting on the claims window, and everyone who files after them, stay on the wrong side of a courtroom door that was never his to open, only his to close.
Sources
- HHS – Secretary Kennedy Signs COVID-19 Emergency Use Authorization Declaration Terminations (June 30, 2026)
- Federal Register – 12th Amendment to the PREP Act Declaration for COVID-19 Medical Countermeasures (Dec. 11, 2024)
- Congressional Research Service – The PREP Act Declaration for COVID-19 Countermeasures (LSB10730)
- HRSA – Countermeasures Injury Compensation Program (CICP) Data
- Congressional Research Service – Compensation for COVID-19 Vaccine Injuries (R46982)
- Axios – RFK Jr. targets vaccine makers’ federal liability protections
- CourtListener – In re Emergent BioSolutions Inc. Securities Litigation (D. Md., 8:21-cv-00955)
- CourtListener – Sinnathurai v. Novavax, Inc. (D. Md., 8:21-cv-02910)
- Maryanne Demasi – HHS Ends COVID Emergency Authorisations, But What Actually Changes?