S. 3853

119 S3853 IS: End the Vaccine Carveout Act
 U.S. Senate
 2026-02-11
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 II  119th CONGRESS  2d Session  S. 3853  IN THE SENATE OF THE UNITED STATES   February 11, 2026   Mr. Paul  (for himself and  Mr. Lee ) introduced the following bill; which was read twice and referred to the  Committee on Health, Education, Labor, and Pensions    A BILL
To amend the Public Health Service Act to end the liability shield for vaccine manufacturers, and for other purposes.
1.
Short title
This Act may be cited as the   End the Vaccine Carveout Act  .
2.
Ending liability shield for vaccine manufacturers
(a)
National Vaccine Injury Compensation Program
(1)
Petitions for compensation
Section 2111 of the Public Health Service Act ( 42 U.S.C. 300aa–11 ) is amended—
(A)
in subsection (a)—
(i)
by striking paragraphs (2), (3), (5), and (6);
(ii)
by inserting after paragraph (1) the following:
(2)
Beginning on the date of enactment of the  End the Vaccine Carveout Act , and subject to paragraph (4)(B), irrespective of whether a person has filed a petition for compensation under the Program in relation to a vaccine-related injury or death, such person may bring a civil action against a vaccine administrator or manufacturer in a State or Federal court for damages arising from such injury or death.
 ;
(iii)
by redesignating paragraph (4) as paragraph (3);
(iv)
by redesignating paragraphs (7) through (10) as paragraphs (4) through (7), respectively; and
(v)
by amending paragraph (4) (as so redesignated) to read as follows:
(4)
(A)
If in a civil action brought against a vaccine administrator or manufacturer for a vaccine-related injury or death damages are awarded under a judgment of a court or a settlement of such action, the person who brought such action may not file a petition under subsection (b) for such injury or death, and any pending petition for such injury or death shall be dismissed.
(B)
If compensation is awarded for a petition filed under the Program for a vaccine-related injury or death, the person who filed such petition may not bring a civil action against a vaccine administrator or manufacturer for such injury or death, and any pending civil action for such injury or death shall be dismissed.
  ; and
(B)
in subsection (c)(1)(B)(i)(III), by striking  not later than 6 months .
(2)
Limitations of actions
Section 2116(b) of the Public Health Service Act ( 42 U.S.C. 300aa–16(b) ) is amended by striking  notwithstanding section 2111(b)(2)  and inserting  notwithstanding section 2111(b)(2), and unless prohibited by section 2111(a)(4)(A) .
(3)
Repeals
(A)
Election
Section 2121(a) of the Public Health Service Act ( 42 U.S.C. 300aa–21(a) ) is repealed.
(B)
Standards of responsibility
Section 2122 of the Public Health Service Act ( 42 U.S.C. 300aa–22 ) is repealed.
(C)
Trial
Section 2123 of the Public Health Service Act ( 42 U.S.C. 300aa–23 ) is repealed.
(4)
Conforming amendments
(A)
Attorneys’ fees
Section 2115(e) of the Public Health Service Act ( 42 U.S.C. 300aa–15(e) ) is amended—
(i)
by striking paragraph (2); and
(ii)
by redesignating paragraph (3) as paragraph (2).
(B)
Payment of compensation
Section 2115(f) of the Public Health Service Act ( 42 U.S.C. 300aa–15(f) ) is amended—
(i)
by striking paragraph (1);
(ii)
by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively;
(iii)
in paragraph (1) (as so redesignated), by striking  Such compensation may not be paid after an election under section 2121(a) to file a civil action for damages for the vaccine-related injury or death for which such compensation was awarded. ; and
(iv)
in paragraph (3)(B) (as so redesignated), by striking  If the appropriations under subsection (j) are insufficient to make a payment of an annual installment, the limitation on civil actions prescribed by section 2121(a) shall not apply to a civil action for damages brought by the petitioner entitled to the payment. .
(C)
State limitations of actions
Section 2116(c) of the Public Health Service Act ( 42 U.S.C. 300aa–16(c) ) is amended by striking  an election is made under section 2121(a) to file the civil action  and inserting  judgment is entered by the United States Court of Federal Claims (or, if an appeal is taken under section 2112(f), the appellate court’s mandate is issued) with respect to the petition .
(D)
Termination of program
Section 2134(b)(1) of the Public Health Service Act ( 42 U.S.C. 300aa–34(b)(1) ) is amended—
(i)
by striking  and accepted under section 2121(a) ; and
(ii)
by striking  Section 2111(a) and part B shall not apply to civil actions for damages for a vaccine-related injury or death for which a petition may not be filed because of subparagraph (B). .
(b)
Excluding COVID–19 vaccines from definition of covered countermeasure
Section 319F–3(i)(1) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(1)) is amended to read as follows:
(1)
Covered countermeasure
The term  covered countermeasure —
(A)
means—
(i)
a qualified pandemic or epidemic product (as defined in paragraph (7));
(ii)
a security countermeasure (as defined in section 319F–2(c)(1)(B));
(iii)
a drug (as such term is defined in section 201(g)(1)) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ), biological product (as such term is defined by section 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 321(h) )) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act; or
(iv)
a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under section 319; and
(B)
does not include any vaccine used to mitigate, prevent, or treat COVID–19.
 .