[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3853 Introduced in Senate (IS)]

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119th CONGRESS
  2d Session
                                S. 3853

To amend the Public Health Service Act to end the liability shield for 
             vaccine manufacturers, and for other purposes.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``End the Vaccine Carveout Act''.

SEC. 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.''.
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