End the Vaccine Carveout Act
- Sponsor
- Rep. Gosar, Paul A. [R-AZ-9]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jul 23, 2025
Bottom line
The bill ends broad liability protections for vaccine manufacturers and administrators, including those for COVID-19 vaccines, allowing individuals to pursue civil lawsuits for vaccine-related injuries or deaths.
What it actually does
This bill significantly alters the legal landscape for vaccine manufacturers and administrators by largely eliminating their liability shields. It amends the Public Health Service Act to allow individuals to bring civil actions directly against vaccine manufacturers or administrators for vaccine-related injuries or deaths, removing the previous requirement to first seek compensation through the National Vaccine Injury Compensation Program (NVICP). Additionally, it explicitly excludes COVID-19 vaccines from the liability protections provided by the Public Readiness and Emergency Preparedness (PREP) Act.
Proponents argue
Proponents argue that the bill restores accountability for vaccine manufacturers and administrators, ensuring that individuals who suffer vaccine-related injuries or deaths have full access to the civil justice system for redress. They contend that the current liability shields unfairly protect corporations at the expense of injured citizens and that removing these protections will incentivize safer vaccine development and manufacturing practices.
Opponents contend
Opponents contend that ending the liability shield for vaccine manufacturers would severely disrupt vaccine research, development, and supply, potentially leading to shortages and higher prices. They argue that the existing National Vaccine Injury Compensation Program (NVICP) provides a no-fault, efficient mechanism for compensation, and that broad liability protections are essential to encourage pharmaceutical companies to produce vaccines, especially during public health emergencies.
The bill is concise and its core provisions are clearly stated, making it accessible for an informed reader to understand its significant policy changes within a short timeframe.
Section 2(a)(1)(A)(ii), amending 42 U.S.C. 300aa-11(a)
Allowing Direct Civil Actions Against Vaccine Manufacturers and Administrators
This provision removes the existing legal requirement that individuals must first file a petition for compensation under the National Vaccine Injury Compensation Program (NVICP) before they can bring a civil action against a vaccine administrator or manufacturer for a vaccine-related injury or death. Upon enactment, individuals would be able to directly sue these entities in State or Federal court.
Supporters argue
Proponents argue that this change ensures full accountability for vaccine manufacturers and administrators, allowing individuals to seek justice and appropriate compensation through the traditional legal system, which they believe offers a more robust avenue for redress than the administrative NVICP.
Critics contend
Opponents contend that allowing direct civil actions will lead to a surge in costly and complex litigation, disincentivizing vaccine production and innovation. They argue that the no-fault NVICP was established precisely to avoid such a scenario and maintain a stable vaccine supply.
Tradeoffs
The provision balances the right of individuals to pursue legal recourse against the potential for increased litigation costs and risks that could impact vaccine availability and development.
Section 2(a)(1)(A)(v), amending 42 U.S.C. 300aa-11(a)(4)
Mutual Exclusivity of Compensation Pathways
This provision establishes that if a person receives damages from a civil action against a vaccine administrator or manufacturer for a vaccine-related injury or death, they cannot also file a petition with the National Vaccine Injury Compensation Program (NVICP) for the same injury, and any pending NVICP petition must be dismissed. Conversely, if compensation is awarded through the NVICP, the person cannot bring a civil action for the same injury, and any pending civil action must be dismissed.
Section 2(a)(2)(A)(i), amending 42 U.S.C. 300aa-16(a)
Eliminating Statute of Limitations for NVICP Claims
This provision removes the existing time limits for filing petitions for compensation under the National Vaccine Injury Compensation Program (NVICP). Previously, petitions for injury had to be filed within 36 months of the first symptom, and for death within 24 months of death and 48 months of the first symptom. Under this bill, petitions for compensation for vaccine-related injuries or deaths may be filed at any time, unless a civil action has already resulted in damages.
Section 2(a)(3), repealing 42 U.S.C. 300aa-21(a), 300aa-22, 300aa-23
Repeal of Key Liability Shield and Procedural Provisions
This section repeals several critical components of the Public Health Service Act that established the vaccine liability shield. Specifically, it repeals the requirement for an 'election' between the NVICP and a civil action (which effectively precluded civil actions), the specific 'standards of responsibility' that protected manufacturers from most tort claims, and provisions governing 'trial' procedures after an NVICP decision. This effectively dismantles the federal framework that shielded vaccine manufacturers from most product liability lawsuits.
Section 2(b), amending 42 U.S.C. 247d-6d(i)(1)
Excluding COVID-19 Vaccines from PREP Act Liability Shield
This provision amends the definition of 'covered countermeasure' under the Public Health Service Act to explicitly exclude any vaccine used to mitigate, prevent, or treat COVID-19. This means that COVID-19 vaccine manufacturers and administrators would no longer be protected from liability under the Public Readiness and Emergency Preparedness (PREP) Act, which was enacted to provide liability immunity for countermeasures used during public health emergencies.
The amendments made by subparagraph (A), which remove time limitations for filing petitions under the National Vaccine Injury Compensation Program (NVICP), shall apply retroactively as if they were included in the original enactment of section 2116 of the Public Health Service Act (42 U.S.C. 300aa-16).
Section 2(a)(2)(B)
Why it matters:While retroactivity clauses are standard legislative drafting tools, their placement here means a casual reader might miss the significant implication that very old claims, previously barred by statute of limitations, could now be filed.
Case for: Proponents would argue that retroactive application ensures that individuals who suffered vaccine injuries many years ago, or whose injuries had a delayed onset, are not unjustly excluded from seeking compensation due to past legal deadlines. It provides a pathway for justice for those previously denied.
Case against: Critics might argue that retroactive application could open the NVICP to a flood of extremely old claims, which could be challenging to adjudicate due to the difficulty of obtaining historical medical records and establishing causation over long periods. This could strain the program's resources and potentially delay compensation for more recent claims.
Estimated impact: Potentially a significant increase in the pool of eligible claims for the NVICP, though the actual number of claims filed and their success rate would depend on individual circumstances and evidentiary standards. It could lead to increased administrative burden and financial payouts from the NVICP fund.