II 

117TH CONGRESS 

2D SESSION S. 3810 

To amend the Countermeasure Injury Compensation Program with respect 

to COVID–19 vaccines. 

IN THE SENATE OF THE UNITED STATES 

MARCH 10 (legislative day, MARCH 7), 2022 

Mr. LEE (for himself, Mr. BRAUN, Mr. JOHNSON, and Mrs. HYDE-SMITH) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Countermeasure Injury Compensation 

Program with respect to COVID–19 vaccines. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Countermeasure Injury 

5 Compensation Fund Amendment Act’’. 

6 SEC. 2. AMENDMENT TO THE COUNTERMEASURE INJURY 

7 COMPENSATION PROGRAM. 

8 Section 319F–4 of the Public Health Service Act (42 

9 U.S.C. 247d–6e) is amended— 

10 (1) in subsection (b)— 


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1 (A) in paragraph (1), by striking ‘‘under 

2 319F–3(b)’’ and inserting ‘‘under section 

3 319F–3(b)’’; 

4 (B) in paragraph (2)— 

5 (i) by striking ‘‘and be in the same 

6 amount’’ and all that follows through 

7 ‘‘shall not apply’’ and inserting ‘‘be in the 

8 same amount, and be subject to the same 

9 conditions as is prescribed by section 

10 2115’’; 

11 (C) by striking paragraphs (3) and (4) and 

12 inserting the following: 

13 ‘‘(3) DETERMINATION OF ELIGIBILITY AND

14 COMPENSATION.—Compensation shall be awarded 

15 under this section to eligible individuals in accord16 ance with the procedure set forth in sections 2111, 

17 2112, 2113, and 2121 for purposes of the National 

18 Vaccine Injury Compensation Program, subject to 

19 the other provisions of this section.’’; 

20 (D) by inserting before paragraph (5) the 

21 following: 

22 ‘‘(4) TIME FOR FILING PETITIONS.— 

23 ‘‘(A) PREVIOUSLY SUBMITTED RE24 QUESTS.— 


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1 ‘‘(i) PENDING CLAIMS.—In the case of 

2 a request for compensation submitted 

3 under this section before the date of enact4 ment of the Countermeasure Injury Com5 pensation Fund Amendment Act for which 

6 no compensation has been provided prior 

7 to such date of enactment, in order to be 

8 eligible for compensation under this sec9 tion, not later than 28 months after such 

10 date of enactment, the individual shall sub11 mit a new petition under this section, con12 sistent with the amendments made by the 

13 Countermeasure Injury Compensation 

14 Fund Amendment Act. 

15 ‘‘(ii) PREVIOUSLY PAID CLAIMS.—In 

16 the case of a request for compensation sub17 mitted under this section and paid under 

18 this section before the date of enactment of 

19 the Countermeasure Injury Compensation 

20 Fund Amendment Act that relates to a 

21 COVID–19 countermeasure, the individual 

22 receiving such compensation may submit a 

23 subsequent petition under this section for 

24 additional compensation in the amount the 

25 individual would have received for such 


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1 claim under this section after such date of 

2 enactment, less the amount already re3 ceived by the individual. 

4 ‘‘(B) SUBSEQUENT PETITIONS.—In the 

5 case of a an injury or death resulting from the 

6 administration or use of a covered counter7 measure to which subparagraph (A) does not 

8 apply, a petition for benefits or compensation 

9 under this section shall be filed not later than— 

10 ‘‘(i) subject to clause (ii)— 

11 ‘‘(I) in the case of serious phys12 ical injury, 3 years after the first 

13 symptom or manifestation of onset of 

14 a significant aggravation of a covered 

15 injury; or 

16 ‘‘(II) in the case of death— 

17 ‘‘(aa) 2 years after death 

18 from the administration or use of 

19 the covered countermeasure; and 

20 ‘‘(bb) 4 years after the oc21 currence of the first symptom or 

22 manifestation of onset or of the 

23 significant aggravation of the in24 jury from which the death re25 sulted; and 


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1 ‘‘(ii) in the case that a covered coun2 termeasure is added to the table under 

3 paragraph (5)(A) and the effect is to per4 mit an individual who was not, before such 

5 addition, eligible to seek compensation 

6 under this section, such individual may file 

7 a petition for such compensation not later 

8 than 2 years after the effective date of the 

9 addition of such countermeasure.’’; 

10 (E) in paragraph (5), by striking subpara11 graphs (B) and (C) and inserting the following: 

12 ‘‘(B) AMENDMENT WITH RESPECT TO

13 COVID–19 VACCINES.— 

14 ‘‘(i) IN GENERAL.—Not later than 60 

15 days after receipt of the report under sub16 paragraph (C)(iii), the Secretary, taking 

17 into consideration such report, shall amend 

18 the covered countermeasure injury table 

19 established under subparagraph (A) to in20 clude all injuries related to COVID–19 

21 vaccines that meet the standard described 

22 in subparagraph (A). In amending such 

23 table, the Secretary shall consider injuries 

24 caused by use of any vaccine that is, or 

25 was, the subject of an emergency use auVerDate Sep 11 2014 23:07 Mar 13, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3810.IS S3810

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1 thorization under section 564 of the Fed2 eral Food, Drug, and Cosmetic Act. 

3 ‘‘(ii) EXPLANATION OF CERTAIN DE4 TERMINATIONS.—With respect to any rec5 ommendation of the COVID–19 Vaccine 

6 Commission included in the report under 

7 subparagraph (C)(iii) that the Secretary 

8 does not adopt pursuant to this subpara9 graph, the Secretary, not later than 7 days 

10 after the covered countermeasure injury 

11 table has been amended pursuant to clause 

12 (i), shall publish a written explanation of 

13 the determination not to adopt such rec14 ommendation. 

15 ‘‘(C) COVID–19 VACCINE COMMISSION.— 

16 ‘‘(i) IN GENERAL.—There is estab17 lished a commission to be known as the 

18 COVID–19 Vaccine Commission (referred 

19 to in this subparagraph as the ‘Commis20 sion’) that is tasked with identifying cov21 ered injuries related to COVID–19 vac22 cines, for purposes of recommending to the 

23 Secretary injuries for inclusion on the cov24 ered countermeasure injury table, as de25 scribed in subparagraph (B). 


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1 ‘‘(ii) MEMBERSHIP.— 

2 ‘‘(I) IN GENERAL.—The Commis3 sion shall be composed of the fol4 lowing: 

5 ‘‘(aa) The Secretary, or a 

6 designee of the Secretary, to 

7 serve as an ex officio member. 

8 ‘‘(bb) The following mem9 bers, selected, not later than 30 

10 days after the date of enactment 

11 of the Countermeasure Injury 

12 Compensation Fund Amendment 

13 Act, in accordance with subclause 

14 (II): 

15 ‘‘(AA) 3 members ap16 pointed by the Chair of the 

17 Committee on Health, Edu18 cation, Labor, and Pensions 

19 of the Senate. 

20 ‘‘(BB) 3 members ap21 pointed by the Ranking 

22 Member of the Committee 

23 on Health, Education, 

24 Labor, and Pensions of the 

25 Senate. 


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1 ‘‘(CC) 3 members ap2 pointed by the Chair of the 

3 Committee on Energy and 

4 Commerce of the House of 

5 Representatives. 

6 ‘‘(DD) 3 members ap7 pointed by the Ranking 

8 Member of the Committee 

9 on Energy and Commerce of 

10 the House of Representa11 tives. 

12 ‘‘(II) ELIGIBILITY.—Members se13 lected to serve on the Commission 

14 pursuant to subclause (I)(bb) shall— 

15 ‘‘(aa) be chosen on the basis 

16 of their experience, integrity, im17 partiality, and good judgement; 

18 ‘‘(bb) at the time of appoint19 ment, not be elected or appointed 

20 officers or employees in the exec21 utive, legislative, or judicial 

22 branch of the Federal Govern23 ment; and 

24 ‘‘(cc) at the time of appoint25 ment, not be a member of the 


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1 board or an employee of an entity 

2 whose product is under review, or 

3 expected to be under review, by 

4 the Commission. 

5 ‘‘(III) NO COMPENSATION.— 

6 Members of the Commission shall not 

7 be compensated. 

8 ‘‘(IV) CONFLICT OF INTEREST.— 

9 Each member of the Commission shall 

10 recuse themselves from advising on a 

11 covered countermeasure for which the 

12 member has a conflict of interest as 

13 described in section 208 of title 18, 

14 United States Code. 

15 ‘‘(iii) REPORT.—No later than one 

16 year after the date of enactment of the 

17 Countermeasure Injury Compensation 

18 Fund Amendment Act, the Commission 

19 shall submit to the Secretary and make 

20 publicly available a report identifying cov21 ered injuries considered for purposes of in22 clusion on the covered countermeasure in23 jury table pursuant to subparagraph (B), 

24 and the vote counts and outcomes for each 

25 such injury. 


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1 ‘‘(iv) SUNSET.—The Commission es2 tablished under this subparagraph shall be 

3 terminated upon publication of the report 

4 under clause (iii).’’; 

5 (F) by redesignating paragraph (6) as 

6 paragraph (7); 

7 (G) by inserting after paragraph (5) the 

8 following: 

9 ‘‘(6) ELECTRONIC FILING OF PETITIONS.—The 

10 clerk of the United States Court of Federal Claims 

11 shall provide an option for the electronic filing of a 

12 petition to initiate a proceeding for compensation 

13 under this section.’’; and 

14 (H) in paragraph (7), as so redesignated— 

15 (i) by striking ‘‘sections 262, 263, 

16 264, 265, and 266’’ and inserting ‘‘sec17 tions 2111, 2112, 2113, 2115, and 2121’’; 

18 (ii) in subparagraph (A), by striking 

19 ‘‘terms ‘vaccine’ and ‘smallpox vaccine’ ’’ 

20 and inserting ‘‘term ‘vaccine’ ’’; 

21 (iii) by amending subparagraph (B) to 

22 read as follows: 

23 ‘‘(B) the term ‘Vaccine Injury Table’ shall 

24 be deemed to mean the table established under 

25 paragraph (5)(A);’’; 


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1 (iv) by redesignating subparagraph 

2 (C) as subparagraph (F); and 

3 (v) by inserting after subparagraph 

4 (B) the following: 

5 ‘‘(C) the term ‘factors unrelated to the ad6 ministration of the vaccine’ shall be deemed to 

7 mean factors unrelated to the administration or 

8 use of a covered countermeasure; 

9 ‘‘(D)(i) the terms ‘petition’, ‘petition under 

10 section 2111’, and ‘petition filed under section 

11 2111’ shall be deemed to mean a request for 

12 compensation under this section; and 

13 ‘‘(ii) the term ‘petitioner’ shall be deemed 

14 to mean a covered individual, as defined in sub15 section (e), who makes a request for benefits or 

16 compensation under this section; 

17 ‘‘(E) the term ‘vaccine-related injury or 

18 death’ shall be deemed to mean a covered in19 jury, as defined in subsection (e); and’’; and 

20 (2) in subsection (d)— 

21 (A) in paragraph (1), by striking ‘‘, or if 

22 the Secretary fails’’ and all that follows through 

23 ‘‘319F–3(d)’’ and inserting a period; and 

24 (B) in paragraph (5), by striking ‘‘under 

25 subsection (a) the Secretary determines that a 


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1 covered individual qualifies for compensation’’ 

2 and inserting ‘‘a covered individual is deter3 mined under subsection (a) to be eligible for 

4 compensation under this section’’. 

Æ 


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