VITAL Act Creates New Federal Crime for Vaccine Trial Fraud, Strips Liability Shields for Lying Sponsors

The Vaccines in Trial and Liability Act of 2025—or VITAL Act—is a major shakeup for anyone involved in testing and manufacturing vaccines and certain medical treatments. Simply put, this bill makes it a federal crime for medical research companies or sponsors to lie or hide important data during clinical vaccine trials. If you’re caught making a fraudulent statement or concealing material data, you could face up to five years in prison, hefty fines, or both (SEC. 2).

The New Standard for Emergency Approval

For most people, the biggest impact of this bill is how it changes the rules for getting fast-tracked medical approvals, like an Emergency Use Authorization (EUA). Currently, EUAs are granted based on certain criteria. Under VITAL, before the FDA can grant an EUA, the company seeking it must officially certify that they didn't make any false statements or hide any key facts related to the circumstances or criteria for approval (SEC. 3). Think of it as a mandatory, signed affidavit of honesty before they can start distributing the product.

Crucially, this bill also gives the Secretary of Health and Human Services (HHS) a clear, powerful tool: the ability to revoke an existing EUA if they discover that the authorization was based on false statements or hidden data (SEC. 4). This means that if a company fudges the numbers to get a product approved quickly, the government can pull the plug on that product's emergency status once the fraud is confirmed.

Losing the Liability Shield: When Honesty Isn't Optional

For years, researchers and manufacturers have enjoyed certain liability protections, especially when dealing with high-risk drugs under the “Right to Try” Act or products developed during public health emergencies (like the COVID-19 pandemic). VITAL carves out massive exceptions to these shields.

If a company is found to have made fraudulent statements or concealed important clinical trial data, they lose their liability protection (SEC. 5, SEC. 6). This is a game-changer. It means that if a product caused harm and the trial data was intentionally misleading, the company can be sued in civil court, potentially facing massive damages, where they previously might have been protected. The bill makes it clear that these protections only stand as long as the company is honest about its data.

Opening the Door to Lawsuits for Fraud

Perhaps the most significant change is to the National Vaccine Injury Compensation Program (NVICP). This program usually shields vaccine makers from civil lawsuits. However, if the Secretary determines that a manufacturer lied or hid material facts about a vaccine’s clinical trial data, that manufacturer loses its protection and can be sued in a regular U.S. district court (SEC. 7).

Even more notable is the financial impact: a plaintiff who wins a lawsuit based on this fraud provision can collect damages from both the NVICP and the civil court case, without one award reducing the other. For manufacturers of COVID-19 vaccines specifically, the bill creates a special rule: if fraud is proven, there is no time limit on when a civil lawsuit can be filed. This creates an open-ended, long-term liability exposure for those specific products, essentially saying the statute of limitations never runs out if the initial data was fraudulent (SEC. 7).

The Secretary’s New Hearing Power

To enforce these provisions, the HHS Secretary gets a formal process to accuse a company of fraud. If the Secretary suspects a company lied, the company gets 30 days to argue its case in a formal hearing. Crucially, the company must hand over all requested documents five days before the hearing, and all arguments—written and spoken—must be posted publicly on the Secretary’s website (SEC. 8). If the company ignores the hearing, the initial finding of fraud stands as final. This ensures that any determination of fraud is transparent and backed by a formal process, even if the final decision rests with the Secretary.