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VITAL Act of 2025

USA119th CongressHR-3631| House 
| Updated: 5/29/2025
Mark E. Green

Mark E. Green

Republican Representative

Tennessee

Judiciary Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Vaccines in Trial and Liability Act of 2025," or VITAL Act , aims to increase accountability for medical research companies and sponsors involved in clinical vaccine trials. It establishes a new federal crime, making it illegal for these entities to knowingly make fraudulent statements or conceal material data from U.S. departments or agencies regarding such trials. Violators could face fines, imprisonment for up to five years, or both. The bill significantly impacts existing liability frameworks by amending several key acts. It mandates that Emergency Use Authorizations (EUAs) for medical products must be based on a certification of no fraud or concealment, allowing for EUA revocation if fraud is discovered. Furthermore, it removes liability limitations under the Right to Try Act and for pandemic and epidemic products if fraudulent material statements were made or information concealed regarding clinical trial data. Crucially, the VITAL Act amends the National Vaccine Injury Compensation Program to permit civil actions against vaccine manufacturers or sponsors when the Secretary of Health and Human Services determines fraud or concealment occurred. Plaintiffs can pursue compensation under the program and concurrently file a lawsuit in federal court, with awarded damages not subject to reduction based on other claims. A significant provision specifically addresses COVID-19 vaccines , allowing civil actions against manufacturers for fraud or concealment related to clinical trial data at any time, effectively removing any statute of limitations. The bill also outlines a process for the Secretary of Health and Human Services to conduct a hearing when fraud is suspected, giving the manufacturer or sponsor an opportunity to refute the determination, with the initial finding of fraud standing if no response is provided.
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Timeline

Bill from Previous Congress

HR 118-8380
VITAL Act of 2024
May 29, 2025
Introduced in House
May 29, 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Oct 8, 2025

Latest Companion Bill Action

S 119-2988
Introduced in Senate
  • Bill from Previous Congress

    HR 118-8380
    VITAL Act of 2024


  • May 29, 2025
    Introduced in House


  • May 29, 2025
    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.


  • October 8, 2025

    Latest Companion Bill Action

    S 119-2988
    Introduced in Senate

Crime and Law Enforcement

VITAL Act of 2025

USA119th CongressHR-3631| House 
| Updated: 5/29/2025
The "Vaccines in Trial and Liability Act of 2025," or VITAL Act , aims to increase accountability for medical research companies and sponsors involved in clinical vaccine trials. It establishes a new federal crime, making it illegal for these entities to knowingly make fraudulent statements or conceal material data from U.S. departments or agencies regarding such trials. Violators could face fines, imprisonment for up to five years, or both. The bill significantly impacts existing liability frameworks by amending several key acts. It mandates that Emergency Use Authorizations (EUAs) for medical products must be based on a certification of no fraud or concealment, allowing for EUA revocation if fraud is discovered. Furthermore, it removes liability limitations under the Right to Try Act and for pandemic and epidemic products if fraudulent material statements were made or information concealed regarding clinical trial data. Crucially, the VITAL Act amends the National Vaccine Injury Compensation Program to permit civil actions against vaccine manufacturers or sponsors when the Secretary of Health and Human Services determines fraud or concealment occurred. Plaintiffs can pursue compensation under the program and concurrently file a lawsuit in federal court, with awarded damages not subject to reduction based on other claims. A significant provision specifically addresses COVID-19 vaccines , allowing civil actions against manufacturers for fraud or concealment related to clinical trial data at any time, effectively removing any statute of limitations. The bill also outlines a process for the Secretary of Health and Human Services to conduct a hearing when fraud is suspected, giving the manufacturer or sponsor an opportunity to refute the determination, with the initial finding of fraud standing if no response is provided.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 118-8380
VITAL Act of 2024
May 29, 2025
Introduced in House
May 29, 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Oct 8, 2025

Latest Companion Bill Action

S 119-2988
Introduced in Senate
  • Bill from Previous Congress

    HR 118-8380
    VITAL Act of 2024


  • May 29, 2025
    Introduced in House


  • May 29, 2025
    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.


  • October 8, 2025

    Latest Companion Bill Action

    S 119-2988
    Introduced in Senate
Mark E. Green

Mark E. Green

Republican Representative

Tennessee

Judiciary Committee, Energy and Commerce Committee

Crime and Law Enforcement

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted