Vaccine Transparency Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 1473 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. IN THE HOUSE OF REPRESENTATIVES MARCH 1, 2021 Mr. STEUBE introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Preven- tion 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Vaccine Transparency 4 Act of 2021’’. 5 VerDate Sep 11 2014 23:37 Apr 14, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1473.IH H1473 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 1473 IH SEC. 2. REPORTS TO CONGRESS ON SERIOUS ADVERSE 1 EVENTS IN CONNECTION WITH COVID–19 2 VACCINES. 3 (a) IN GENERAL.—Not later than 60 days after the 4 date of enactment of this Act, and every 60 days there- 5 after, the Commissioner of Food and Drugs and the Direc- 6 tor of the Centers for Disease Control and Prevention, act- 7 ing jointly, shall submit a report to the Congress on all 8 serious adverse events that are reported— 9 (1) to either agency pursuant to the Vaccine 10 Adverse Event Reporting System or otherwise dur- 11 ing the period covered by the report; and 12 (2) in connection with a COVID–19 vaccine. 13 (b) INITIAL REPORT.—The reporting period of the 14 initial report under subsection (a) shall begin on the date 15 when the Commissioner of Food and Drugs first author- 16 ized emergency use of a COVID–19 vaccine under section 17 564 of the Federal Food, Drug, and Cosmetic Act (21 18 U.S.C. 360bbb–3). 19 Æ VerDate Sep 11 2014 23:37 Apr 14, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H1473.IH H1473 kjohnson on DSK79L0C42PROD with BILLS