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S. 4542: America First Vaccine Act


The text of the bill below is as of Sep 9, 2020 (Introduced).


II

116th CONGRESS

2d Session

S. 4542

IN THE SENATE OF THE UNITED STATES

September 9, 2020

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.

Short title

This Act may be cited as the America First Vaccine Act.

2.

COVID–19 vaccine distribution

(a)

Certification requirement

(1)

In general

Notwithstanding any other provision of law, subject to paragraph (2), a manufacturer of a vaccine described in subsection (b) that is headquartered in the United States may not distribute such vaccine outside of the United States unless the Secretary of Health and Human Services (referred to in this section as the Secretary), in consultation with the Commissioner of Food and Drugs, certifies that domestic need for the vaccine already has been met.

(2)

Waiver

The Secretary may waive the certification requirement under paragraph (1) with respect to a vaccine described in subsection (b) and permit the distribution of such vaccine outside of the United States, if the Secretary determines that such waiver and distribution is in the interest of the American public health.

(b)

Vaccines described

A vaccine described in this subsection is a COVID–19 vaccine that—

(1)

is authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262); and

(2)

was developed with support of Federal funding made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act (Public Law 116–123), the Families First Coronavirus Response Act (Public Law 116–127), the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116–136), or the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139).

(c)

Violations

In the case of a manufacturer who violates subsection (a), such manufacturer shall be required to reimburse the Federal Government for all amounts received by the manufacturer in support of development of the vaccine, plus interest in an amount determined by the Secretary of the Treasury.

(d)

Rule of construction

Nothing in this Act shall be construed to limit or otherwise restrict the Secretary’s authority to enter into bilateral or multilateral agreements with international manufacturers to procure vaccines described in subsection (b) for the people of the United States.