II 

116TH CONGRESS 

2D SESSION S. 4427 

To provide for transparency in emergency use authorization of vaccine 

products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 4, 2020 

Ms. HASSAN (for herself, Mr. BRAUN, and Ms. MURKOWSKI) introduced the 

following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To provide for transparency in emergency use authorization 

of vaccine products, and for other purposes. 

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 ‘‘Safe Authorization for 

5 Vaccines during Emergencies Act’’ or the ‘‘SAVE Act’’. 

6 SEC. 2. TRANSPARENCY IN EMERGENCY USE AUTHORIZA7 TION OF VACCINE PRODUCTS. 

8 (a) EMERGENCY USE AUTHORIZATIONS.— 


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1 (1) IN GENERAL.—Section 564 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

3 3) is amended by adding at the end the following: 

4 ‘‘(n) REQUIREMENTS WITH RESPECT TO VACCINE

5 PRODUCTS DURING PUBLIC HEALTH EMERGENCIES.— 

6 ‘‘(1) EMERGENCY MEETING AND RECOMMENDA7 TIONS.— 

8 ‘‘(A) EMERGENCY MEETING.—During a 

9 public health emergency declared by the Sec10 retary under section 319 of the Public Health 

11 Service Act and with respect to a request to au12 thorize the use of an unapproved product that 

13 is a vaccine or an unapproved use of an ap14 proved product that is a vaccine intended to ad15 dress the public health threat that is the sub16 ject of such public health emergency, prior to 

17 authorizing use of such product, subject to sub18 paragraph (B), the Secretary shall convene a 

19 meeting at which the Food and Drug Adminis20 tration and the sponsor of the product present 

21 data and information on the product to the 

22 Vaccines and Related Biological Products Advi23 sory Committee for the purpose of reviewing 

24 and providing recommendations with respect to 

25 emergency use of the product. 


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1 ‘‘(B) EXCEPTION.—If the Secretary, in 

2 consultation with the Commissioner, determines 

3 that a meeting under subparagraph (A) with re4 spect to a product described in such subpara5 graph would not be in the public interest, the 

6 Secretary may make a determination not to 

7 convene such a meeting. In the event that the 

8 Secretary determines not to convene such a 

9 meeting pursuant to this subparagraph, the 

10 Secretary shall issue a report to the Committee 

11 on Health, Education, Labor, and Pensions of 

12 the Senate and the Committee on Energy and 

13 Commerce of the House of Representatives that 

14 includes justification and relevant public health 

15 grounds for such determination. 

16 ‘‘(2) REQUIREMENT TO SEEK LICENSURE.—An 

17 authorization under this section with respect to an 

18 unapproved product that is a vaccine or an unap19 proved use of an approved product that is a vaccine 

20 shall be conditioned on the sponsor seeking licensure 

21 of the product, or the use, as applicable, under sec22 tion 351 of the Public Health Service Act, at the 

23 discretion of the Secretary, within a time period de24 termined by the Secretary.’’. 


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1 (2) CONFIDENTIAL INFORMATION.—Section 

2 564(h)(1) of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 360bbb–3(h)(1)) is amended— 

4 (A) by inserting ‘‘, including a summary 

5 review,’’ after ‘‘data or information’’; 

6 (B) by striking ‘‘505(i), 512(j), or 520(g)’’ 

7 and inserting ‘‘505, 510(k), 512(j), 513(f), 515, 

8 520(g), or 564 of this Act or section 351 of the 

9 Public Health Service Act’’; and 

10 (C) by striking ‘‘may indirectly reveal the 

11 existence of such application’’ and inserting ‘‘, 

12 including a summary review, may indirectly re13 veal the existence of such application or contain 

14 data or information submitted in an application 

15 under such sections’’. 

16 (b) RECOMMENDATIONS WITH RESPECT TO VAC17 CINES TO ADDRESS A PUBLIC HEALTH EMERGENCY.— 

18 Section 319 of the Public Health Service Act (42 U.S.C. 

19 247d) is amended by adding at the end the following: 

20 ‘‘(c) RECOMMENDATIONS.—During a public health 

21 emergency declared by the Secretary under subsection (a), 

22 not later than 15 days after the authorization under sec23 tion 564 of the Federal Food, Drug, and Cosmetic Act 

24 of an unapproved product that is a vaccine or an unap25 proved use of an approved product that is a vaccine inVerDate Sep 11 2014 22:42 Aug 26, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4427.IS S4427

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1 tended to address the public health threat that is the sub2 ject of such public health emergency, the Advisory Com3 mittee on Immunization Practices shall submit to the Di4 rector of the Centers for Disease Control and Prevention, 

5 the Secretary, the Committee on Health, Education, 

6 Labor, and Pensions of the Senate, and the Committee 

7 on Energy and Commerce of the House of Representa8 tives— 

9 ‘‘(1) recommendations regarding vaccination, 

10 including prioritization of populations for which the 

11 vaccine is authorized; or 

12 ‘‘(2) a report recommending that the Secretary 

13 seek additional data or information in order for the 

14 committees to develop recommendations described in 

15 paragraph (1).’’. 

Æ 


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