If you were harmed by a COVID-19 shot and want to file a COVID vaccine lawsuit, the practical answer is narrow: the PREP Act shields manufacturers, providers, and federal officials from almost all direct injury suits, and Congress routed COVID-19 vaccine claims to a federal compensation program that has paid a small fraction of applicants. The active courtroom fights in 2026 are not personal injury cases at all. They are consumer-protection suits brought by state attorneys general against Pfizer, and a federal challenge by major medical organizations to HHS Secretary Robert F. Kennedy Jr.’s changes to the vaccine schedule.
Why Suing the Manufacturer Is Almost Impossible
HHS invoked the Public Readiness and Emergency Preparedness Act in February 2020. That declaration gives manufacturers, healthcare providers, and federal officials broad immunity from liability for covered countermeasures, including the COVID-19 vaccines, unless a plaintiff can prove “willful misconduct.”1CNBC. COVID Vaccine Side Effects Compensation
The willful misconduct route is not a realistic path for most people. It requires filing exclusively in the U.S. District Court for the District of Columbia, pleading with particularity, attaching a doctor’s affidavit and certified medical records, and proving the misconduct by clear and convincing evidence.2Drug and Device Law Blog. Searcy v. Pfizer and PREP Act Immunity
Courts have consistently upheld this immunity. A federal court in Washington dismissed a suit in September 2024 brought by a woman who suffered a stroke after receiving the Moderna vaccine, finding Moderna was a covered manufacturer distributing a covered countermeasure.3American Health Law Association. U.S. Court in Washington Tosses COVID-19 Vaccine Injury Suit In September 2025, an Alabama federal court dismissed the wrongful death case Searcy v. Pfizer and rejected constitutional challenges under the Due Process Clause, the Takings Clause, the Seventh Amendment, and the Commerce Clause, holding that channeling relief through the federal compensation program does not violate the right to a jury trial.2Drug and Device Law Blog. Searcy v. Pfizer and PREP Act Immunity
Where COVID-19 Injury Claims Actually Go
COVID-19 vaccines are not covered by the National Vaccine Injury Compensation Program, sometimes called “vaccine court.” They are covered by a separate and much narrower program: the Countermeasures Injury Compensation Program, administered by the Health Resources and Services Administration. COVID-19 vaccines are set to remain under the CICP through the end of 2029, and moving them to the VICP would require an act of Congress.4KFF. Federal Vaccine Injury Compensation Programs: Overview and Current Issues
The numbers tell you what to expect. As of March 2026, the CICP had received 10,981 COVID-19 vaccine claims. Roughly half of all claims across all countermeasures had been decided, and of the COVID-19 vaccine claims that had been decided, only 95 — about 0.9% — were found eligible for compensation.4KFF. Federal Vaccine Injury Compensation Programs: Overview and Current Issues A December 2024 Government Accountability Office report found HRSA had paid only about $400,000 total for COVID-19 vaccine injuries, out of roughly $6.5 million in total CICP payouts across all countermeasures since 2009.5GAO. Countermeasures Injury Compensation Program
The GAO cited staff shortages, outdated information systems, limited scientific evidence for causation with a new vaccine, and an average 24-month review time. The most common reason for denial was missing the program’s one-year filing deadline.5GAO. Countermeasures Injury Compensation Program That one-year window is strict, and it starts running from the date of the countermeasure administration.
If a claim is approved, the money is limited. The CICP does not cover pain and suffering or attorney’s fees, and it caps annual lost-wage-and-medical payments at $50,000.1CNBC. COVID Vaccine Side Effects Compensation There is no formal legal appeal; all decisions are handled internally by HHS.4KFF. Federal Vaccine Injury Compensation Programs: Overview and Current Issues Approved awards have generally been modest. Program data through April 2026 shows two COVID-19 vaccine claims for Guillain-Barré Syndrome were compensated, at roughly $3,500 and $7,000.6HRSA. CICP Data – Table 4 Across all countermeasures, 74% of compensation awards were under $10,000.
State Attorneys General Suing Pfizer
Because personal injury suits are blocked, the live claims against Pfizer come from state attorneys general using state consumer protection laws. These are not claims for physical injury. They allege deceptive marketing.
Kansas: Case Proceeding in State Court
Kansas Attorney General Kris Kobach filed suit against Pfizer in Thomas County, Kansas, in June 2024, alleging violations of the Kansas Consumer Protection Act. The complaint accused Pfizer of downplaying risks of myocarditis, pericarditis, and complications during pregnancy.7Kansas Attorney General. Kansas v. Pfizer Case Update Pfizer removed the case to federal court in July 2024, and in May 2025 a federal judge sent it back to state court. Pfizer said the ruling addressed only jurisdiction and that the company intends to “vigorously defend” the claims on the merits.8KCTV5. Case Filed Against Pfizer for COVID Vaccine Marketing to Be Heard at State Level
Texas: Case Dismissed
Texas Attorney General Ken Paxton filed a similar suit alleging misrepresentation and deceptive trade practices regarding vaccine efficacy. In December 2024, District Judge Sam Cummings dismissed it, ruling that Pfizer is protected under the PREP Act.9KCBD. Lubbock Judge Dismisses Paxton’s Lawsuit Against Pfizer The split outcome reflects how narrowly a claim has to be framed to stay out of the immunity zone.
Medical Groups v. Kennedy: Fight Over the Vaccine Schedule
The most consequential COVID-19 vaccine case moving through federal court right now is not about compensation. It is about whether HHS can pull the vaccine off the recommended schedule.
In May 2025, HHS Secretary Robert F. Kennedy Jr. signed a directive removing COVID-19 vaccines from the recommended schedule for healthy children and pregnant women.10STAT News. Doctors Groups Sue RFK Jr. Over Vaccine Policy Changes He had already dismissed all 17 members of the CDC’s Advisory Committee on Immunization Practices and replaced them with a smaller panel that included figures known for vaccine skepticism.11NPR. Medical Groups Sue HHS Over Vaccine Policy Changes
In July 2025, the American Academy of Pediatrics, the American College of Physicians, the American Public Health Association, the Infectious Diseases Society of America, the Society for Maternal-Fetal Medicine, and others sued in the U.S. District Court for the District of Massachusetts. They argued the actions were “arbitrary and capricious” under the Administrative Procedure Act and that Kennedy had bypassed the legally required consultation with ACIP before altering recommendations.10STAT News. Doctors Groups Sue RFK Jr. Over Vaccine Policy Changes
In January 2026, Kennedy and the CDC cut the childhood vaccine schedule from 18 diseases to 11, removing recommendations for hepatitis A, hepatitis B, RSV, dengue, and two types of bacterial meningitis.12NBC News. Trump, RFK Jr. Appeal Ruling That Blocked Vaccine Overhaul The plaintiffs amended their complaint to challenge those changes too.
On March 16, 2026, Judge Brian Murphy ruled that Kennedy had “unlawfully” replaced ACIP and issued a temporary order blocking the schedule changes. The ruling nullified the appointments and votes of the 13 members Kennedy had installed and halted decisions the reconstituted committee had made.13PBS NewsHour. Judge Blocks RFK Jr. From Scaling Back Childhood Vaccine Recommendations A planned ACIP meeting to discuss COVID-19 vaccines was postponed indefinitely.12NBC News. Trump, RFK Jr. Appeal Ruling That Blocked Vaccine Overhaul
The Trump administration appealed to the First Circuit on April 29, 2026. As of mid-June 2026, the court had issued a scheduling order and the government had moved to expedite the appeal, but no ruling had been issued. HHS has signaled it may seek emergency relief to pause the district court’s order while the appeal is pending.14Georgetown Law Litigation Tracker. American Academy of Pediatrics et al. v. Kennedy et al.
Where the Mandate Cases Landed
Lawsuits over COVID-19 vaccine mandates have largely resolved. In January 2022, the Supreme Court blocked the Biden administration’s OSHA vaccine-or-testing mandate for employers with 100 or more employees in a 6-3 ruling in National Federation of Independent Business v. OSHA, holding that OSHA lacked statutory authority for a broad public health measure under the major questions doctrine.15Supreme Court of the United States. National Federation of Independent Business v. Department of Labor, OSHA In a separate 5-4 ruling in Biden v. Missouri, the Court upheld a CMS mandate requiring vaccination for workers at Medicare- and Medicaid-funded healthcare facilities.16APIC. Supreme Court Rules on COVID-19 Vaccine Mandates
Challenges to the federal employee mandate became moot after President Biden rescinded the executive order in May 2023, and the Supreme Court vacated the lower court decisions, leaving unresolved whether a future administration could impose a similar mandate. The military mandate was rescinded in January 2023 through the National Defense Authorization Act.17Hall Benefits Law. U.S. Supreme Court Vacates Decisions on Biden’s Vaccine Requirements for Federal Employees as Moot On January 27, 2025, President Trump signed an executive order directing reinstatement of service members involuntarily separated for refusing the COVID-19 vaccine, with restoration of rank and full back pay.18The White House. Reinstating Service Members Discharged Under the Military’s COVID-19 Vaccination Mandate The Department of Defense issued implementation guidance on April 1, 2025.19DFAS. COVID-19 Military Reinstatement
Bills That Would Change the Picture
Two very different reform tracks are pending in Congress, and neither has advanced. In August 2023, Representatives Lloyd Doggett of Texas and Lloyd Smucker of Pennsylvania introduced the Vaccine Injury Compensation Modernization Act, which would move pending COVID-19 vaccine claims from the CICP to the VICP, add special masters, raise compensation caps frozen since 1988, and index payments for inflation.20Office of Rep. Doggett. Rep. Doggett Files Legislation to Modernize Vaccine Injury Compensation Program The bill did not advance.4KFF. Federal Vaccine Injury Compensation Programs: Overview and Current Issues
In February 2026, Senators Rand Paul and Mike Lee introduced the End the Vaccine Carveout Act to eliminate the liability protections that shield vaccine manufacturers from lawsuits, with Representative Paul Gosar filing a companion bill in the House.21Office of Sen. Lee. Lee, Paul Introduce End to Vaccine Carveouts The Senate bill was referred to the Committee on Health, Education, Labor, and Pensions, where it remained as of mid-2026.22Congress.gov. S.3853 – End the Vaccine Carveout Act
Until one of those bills becomes law, the framework holds: a CICP filing within one year of the shot is the practical option for an injury claim, and direct suits against manufacturers face a wall the courts have not moved.