SEC. 2. REQUIRED CONSIDERATION OF ADVISORY COM-
MITTEE RECOMMENDATIONS. 
(a) VACCINE LICENSURE OR AUTHORIZATION.—Be-
fore licensing or authorizing any vaccine for COVID–19 
or SARS–CoV–2 infection (in this section referred to as 
a ‘‘COVID–19 vaccine’’), the Commissioner of Food and 
Drugs shall— 
(1) solicit recommendations from the Vaccines 
and Related Biological Products Advisory Committee 
on whether the available data are adequate to sup-
port the safety and effectiveness of the COVID–19 
vaccine and whether additional studies to further 
evaluate safety and effectiveness should be required 
before or after licensing or authorization; 
(2) receive such recommendations at an open 
meeting; 
(3) give public notice of such meeting at least 
3 business days in advance of the meeting; and 
(4) publicly document how such recommenda-
tions were considered when licensing or authorizing 
the COVID–19 vaccine. 
(b) MINOR OR TECHNICAL CHANGES.—Subsection 
(a) does not apply— 
(1) to minor or technical changes to a license 
or authorization that is in effect; or 
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(2) in cases involving a change to a license or 
authorization if the Commissioner of Food and 
Drugs publishes a determination that the change is 
not substantial and a meeting under subsection (a) 
would not be appropriate. 
(c) PROVISION OF INFORMATION.— 
(1) IN GENERAL.—In connection with a meet-
ing of the Vaccines and Related Biological Products 
Advisory Committee convened for purposes of sub-
section (a), the Commissioner of Food and Drugs 
shall— 
(A) provide to the Advisory Committee, at 
least 3 business days prior to the meeting, any 
data, summaries of data, briefing documents, 
and other information to be presented at the 
meeting by the Commissioner and the sponsor 
of the COVID–19 vaccine, and make reasonable 
efforts to provide any additional data, sum-
maries of data, or information requested by the 
Advisory Committee before the meeting; and 
(B) promptly make available on the Food 
and Drug Administration’s website minutes, 
audiovisual recordings, transcripts, data, sum-
maries of data, briefing documents, and other 
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information or documents made available to or 
prepared for or by the Advisory Committee. 
(2) EXCEPTION.—The Commissioner need not 
make available minutes, audiovisual recordings, 
transcripts, data, summaries of data, briefing docu-
ments, and other information or documents pursu-
ant to paragraph (1)(B) if the Commissioner— 
(A) determines that the minutes, audio-
visual recordings, transcripts, data, summaries 
of data, briefing documents, or other informa-
tion or documents should be withheld from dis-
closure in accordance with section 552b(c) of 
title 5, United States Code; and 
(B) promptly makes available on the public 
website of the Food and Drug Administration a 
written explanation of the reasons for not dis-
closing the minutes, audiovisual recordings, 
transcripts, data, summaries of data, briefing 
documents, or other information or documents. 
Æ 
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