S. 4542, America First Vaccine Act
Summary
S. 4542, the America First Vaccine Act, was introduced September 9, 2020 by Mr. Tillis and referred to the Committee on Banking, Housing, and Urban Affairs. It is 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. Section 2 provides that a manufacturer of a vaccine that is headquartered in the United States may not distribute it outside of the United States unless the Secretary of Health and Human Services certifies that domestic need already has been met. The Secretary may waive the certification requirement.
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Cite this document
“S. 4542, America First Vaccine Act.”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/bills-bills-116s4542is-bills-116s4542is/
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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 devel-
oped with the support of Federal funding until the do-
mestic need for the vaccine has been met.
1 Be it enacted by the Senate and House of Representa-
2 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.—
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8 (1) IN GENERAL.—Notwithstanding any other
9 provision of law, subject to paragraph (2), a manu-
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2
1 facturer of a vaccine described in subsection (b) that
2 is headquartered in the United States may not dis-
3 tribute such vaccine outside of the United States un-
4 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 Fed-
19 eral Food, Drug, and Cosmetic Act (21 U.S.C.
20 360bbb–3) or licensed under section 351 of the Pub-
21 lic Health Service Act (42 U.S.C. 262); and
22 (2) was developed with support of Federal fund-
23 ing made available under the Coronavirus Prepared-
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24 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 Protec-
4 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 re-
8 quired to reimburse the Federal Government for all
9 amounts received by the manufacturer in support of devel-
10 opment of the vaccine, plus interest in an amount deter-
11 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 Sec-
14 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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