VITAL Act of 2025
The Vaccines in Trial and Liability Act of 2025 (VITAL Act of 2025) is a broad bill aimed at strengthening accountability around clinical vaccine trials and expanding avenues for redress when fraud is alleged. It creates criminal penalties for medical research companies or sponsors that make fraudulent statements or conceal material data from U.S. government agencies during vaccine trials. It also conditions certain federal vaccine approvals on a certification that no fraudulent statements were made or data concealed. In addition, the bill broadens liability protections for pandemic-countermeasure products in some contexts while adding new limitations on liability if fraud is involved, and it expands the National Vaccine Injury Compensation Program (NVICP) to cover fraud-related claims and allow concurrent civil actions. A formal hearing process is established to review accusations of fraud, with public disclosure of testimony. Overall, the bill seeks to deter trial fraud, tighten oversight of vaccine data, and create more paths for individuals to obtain compensation when fraud is alleged.
Key Points
- 1Criminal penalties for fraud in vaccine trials: Medical research companies or sponsors that make fraudulent statements or conceal material trial data to U.S. agencies can be fined, imprisoned for up to 5 years, or both (new 18 U.S.C. §1041).
- 2Certification-based authorization: FDA/EUA/licensure for vaccines would require a certification from the sponsor that there were no fraudulent statements or concealed data relevant to the trial.
- 3Revocation and correction: If the Secretary determines fraudulent statements were made or data concealed, authorization for a vaccine can be revised or revoked accordingly.
- 4Liability and Right to Try: The Right to Try framework is amended so that liability protections do not apply if fraudulent data or concealment occurred in trials of the investigational drug.
- 5Pandemic countermeasures: Expands liability carve-outs and enforcement provisions for fraud related to vaccines or countermeasures used during pandemics or epidemics; includes a damages provision stating damages are not offset by other awards.
- 6NVICP reform: Adds fraud-based eligibility in the National Vaccine Injury Compensation Program, allowing claimants to pursue NVICP relief and concurrently sue in federal court; protects damages from being reduced by other awards; special provisions for COVID-19 vaccines, including no time limit for civil actions related to COVID-19.
- 7Fraud hearing process: Creates a formal process for determining fraud, including a 30-day window for the manufacturer to refute a determination, a schedule for hearings, document requests, and public publication of hearing testimony. If there is no response, the initial fraud determination remains in effect.