II 

116TH CONGRESS 

2D SESSION S. 4542 

To prohibit distribution abroad of COVID–19 vaccines developed with the 

support of Federal funding until the domestic need for the vaccine 

has been met. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 9, 2020 

Mr. TILLIS introduced the following bill; which was read twice and referred 

to the Committee on Banking, Housing, and Urban Affairs 

A BILL 

To prohibit distribution abroad of COVID–19 vaccines developed with the support of Federal funding until the domestic need for the vaccine has been met. 

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 ‘‘America First Vaccine 

5 Act’’. 

6 SEC. 2. COVID–19 VACCINE DISTRIBUTION. 

7 (a) CERTIFICATION REQUIREMENT.— 

8 (1) IN GENERAL.—Notwithstanding any other 

9 provision of law, subject to paragraph (2), a manuVerDate Sep 11 2014 17:41 Sep 10, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4542.IS S4542

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•S 4542 IS

1 facturer of a vaccine described in subsection (b) that 

2 is headquartered in the United States may not dis3 tribute such vaccine outside of the United States un4 less the Secretary of Health and Human Services 

5 (referred to in this section as the ‘‘Secretary’’), in 

6 consultation with the Commissioner of Food and 

7 Drugs, certifies that domestic need for the vaccine 

8 already has been met. 

9 (2) WAIVER.—The Secretary may waive the 

10 certification requirement under paragraph (1) with 

11 respect to a vaccine described in subsection (b) and 

12 permit the distribution of such vaccine outside of the 

13 United States, if the Secretary determines that such 

14 waiver and distribution is in the interest of the 

15 American public health. 

16 (b) VACCINES DESCRIBED.—A vaccine described in 

17 this subsection is a COVID–19 vaccine that— 

18 (1) is authorized under section 564 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

20 360bbb–3) or licensed under section 351 of the Pub21 lic Health Service Act (42 U.S.C. 262); and 

22 (2) was developed with support of Federal fund23 ing made available under the Coronavirus Prepared24 ness and Response Supplemental Appropriations Act 

25 (Public Law 116–123), the Families First 


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1 Coronavirus Response Act (Public Law 116–127), 

2 the Coronavirus Aid, Relief, and Economic Security 

3 Act (Public Law 116–136), or the Paycheck Protec4 tion Program and Health Care Enhancement Act 

5 (Public Law 116–139). 

6 (c) VIOLATIONS.—In the case of a manufacturer who 

7 violates subsection (a), such manufacturer shall be re8 quired to reimburse the Federal Government for all 

9 amounts received by the manufacturer in support of devel10 opment of the vaccine, plus interest in an amount deter11 mined by the Secretary of the Treasury. 

12 (d) RULE OF CONSTRUCTION.—Nothing in this Act 

13 shall be construed to limit or otherwise restrict the Sec14 retary’s authority to enter into bilateral or multilateral 

15 agreements with international manufacturers to procure 

16 vaccines described in subsection (b) for the people of the 

17 United States. 

Æ 


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