117th CONGRESS 1st Session |
To require the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention to report to Congress all serious adverse events that are reported to such agencies in connection with administration of a COVID–19 vaccine, and for other purposes.
March 1, 2021
Mr. Steube introduced the following bill; which was referred to the Committee on Energy and Commerce
To require the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention to report to Congress all serious adverse events that are reported to such agencies in connection with administration of a COVID–19 vaccine, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Vaccine Transparency Act of 2021”.
SEC. 2. Reports to Congress on serious adverse events in connection with COVID–19 vaccines.
(a) In general.—Not later than 60 days after the date of enactment of this Act, and every 60 days thereafter, the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, acting jointly, shall submit a report to the Congress on all serious adverse events that are reported—
(1) to either agency pursuant to the Vaccine Adverse Event Reporting System or otherwise during the period covered by the report; and
(2) in connection with a COVID–19 vaccine.
(b) Initial report.—The reporting period of the initial report under subsection (a) shall begin on the date when the Commissioner of Food and Drugs first authorized emergency use of a COVID–19 vaccine under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3).