[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72489-72491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1137]


Development and Licensure of Vaccines To Prevent COVID-19; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a revised guidance for industry entitled ``Development 
and Licensure of Vaccines to Prevent COVID-19.'' This guidance revises 
the guidance of the same name, which was announced in the Federal 
Register on August 3, 2020. FDA is issuing this guidance to assist the 
Agency and sponsors in the clinical development and licensure of 
vaccines for the prevention of COVID-19. Additionally, this guidance 
provides an overview of key considerations to satisfy regulatory 
requirements set forth in the investigational new drug application 
(IND) regulations and in the licensing regulations for chemistry, 
manufacturing, and controls (CMC), and nonclinical and clinical data 
through development and licensure, and for post-licensure safety 
evaluation of COVID-19 preventive vaccines. FDA is also announcing the 
withdrawal of an FDA guidance document related to COVID-19.

DATES: The announcement of the guidance is published in the Federal 
Register on October 20, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-D-1137 for ``Development and Licensure of Vaccines to Prevent 
COVID-19.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For

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more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica Gillum, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a revised guidance for 
industry entitled ``Development and Licensure of Vaccines to Prevent 
COVID-19.'' The recommendations described in the guidance are expected 
to assist the Agency and sponsors in the clinical development and 
licensure of vaccines for the prevention of COVID-19.
    Due to the COVID-19 public health emergency, there was an urgent 
need to develop safe and effective vaccines to prevent COVID-19 and 
work collaboratively with industry and other partners to accelerate 
those efforts. To help address those needs, in June 2020, FDA issued a 
guidance entitled ``Development and Licensure of Vaccines to Prevent 
COVID-19'' (the ``June 2020 guidance'') to assist sponsors in the 
clinical development and licensure of vaccines for the prevention of 
COVID-19. The June 2020 guidance, which was announced in the Federal 
Register on August 3, 2020 (85 FR 46641), explained that we expected 
the recommendations would continue to apply outside the context of the 
COVID-19 public health emergency, and that FDA would replace that 
guidance with any appropriate changes based on public comments and our 
experience with implementation. In addition, in the Federal Register of 
March 13, 2023 (88 FR 15417), FDA listed the June 2020 guidance as one 
of the guidances the Agency was revising to continue in effect for 180 
days after the COVID-19 public health emergency declaration issued 
under the Public Health Service Act expired on May 11, 2023, during 
which time FDA planned to further revise those guidances. Consistent 
with what we said in the Federal Register of March 13, 2023, FDA is 
issuing this revised final guidance.
    We are issuing this revised guidance consistent with our good 
guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). We 
are implementing this guidance without prior public comment because we 
have determined that prior public participation is not feasible or 
appropriate (see Sec.  10.115(g)(2) and section 701(h)(1)(C) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
371(h)(1)(C)). We made this determination because the revisions to the 
guidance acknowledge the current epidemiology of COVID-19 or reflect 
current recommendations provided to sponsors and immediate 
implementation is required to facilitate the development of vaccines to 
protect the public health. Specifically, we are issuing this guidance 
to ensure that sponsors are aware of our current recommendations to 
expedite the timely development of vaccines to prevent COVID-19. In 
addition, we note that interested parties have had the opportunity to 
comment on the June 2020 guidance. Although this guidance document is 
being implemented immediately, it remains subject to comment in 
accordance with FDA's GGP regulation (Sec.  10.115(g)(3)(D)).
    The revised guidance provides an overview of key considerations to 
satisfy regulatory requirements set forth in the IND regulations in 
part 312 (21 CFR part 312) and licensing regulations in part 601 (21 
CFR part 601) for CMC, and nonclinical and clinical data through 
development and licensure, and for post-licensure safety evaluation of 
COVID-19 preventive vaccines. FDA is committed to supporting all 
scientifically sound approaches to attenuating the clinical impact of 
COVID-19. There are many candidate COVID-19 vaccines currently in 
development, and FDA recognizes that the considerations presented do 
not represent all the considerations necessary to satisfy statutory and 
regulatory requirements applicable to the licensure of vaccines 
intended to prevent COVID-19. The nature of a particular vaccine and 
its intended use may impact specific data needs.
    We received numerous comments on the June 2020 guidance. Those 
comments were considered and the revisions in this guidance reflect the 
responses to the comments as appropriate. Changes to the guidance from 
the June 2020 guidance include removal of reference to the COVID-19 
public health emergency and revisions to the nonclinical data section 
to take into consideration that enhanced respiratory disease has not 
occurred with clinical use of COVID-19 vaccines. The clinical trials 
section has been revised to reflect that at this stage of the pandemic 
only very young children are likely to be serologically na[iuml]ve and, 
in recognition of the available data on vaccine effectiveness, to 
recommend that sponsors provide appropriate justification for 
statistical criteria for clinical disease efficacy studies. In 
addition, editorial changes were made to improve clarity. The revised 
guidance announced in this notice replaces the June 2020 guidance.
    The revised guidance represents the current thinking of FDA on the 
development and licensure of vaccines to prevent COVID-19. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in part 312 have been approved under OMB control number 0910-0014; the 
collections of information in 21 CFR part 58 regarding good laboratory 
practice for nonclinical laboratory studies have been approved under 
OMB control number 0910-0119; the collections of information in 21 CFR 
part 50 have been approved under OMB control number 0910-0130; the 
collections of information in 21 CFR parts 210, 211 and 610 have been 
approved under OMB control number 0910-0139; the collections of 
information in 21 CFR part 600 have been approved under OMB control

[[Page 72491]]

numbers 0910-0308 and 0910-0291 (Form FDA 3500A); the collections of 
information in part 601 have been approved under OMB control number 
0910-0338; the collections of information in FDA's guidance entitled 
``Establishment and Operation of Clinical Trial Data Monitoring 
Committees'' have been approved under OMB control number 0910-0581; 
and, the collections of information in FDA's guidance entitled 
``Emergency Use Authorization of Medical Products and Related 
Authorities'' have been approved under OMB control number 0910-0595.

III. Emergency Use Authorization for Vaccines To Prevent COVID-19 
Guidance

    In October 2020, FDA first issued a guidance entitled ``Emergency 
Use Authorization for Vaccines to Prevent COVID-19'' (Vaccine EUA 
guidance) to provide sponsors of requests for emergency use 
authorization (EUA) for COVID-19 vaccines with recommendations 
regarding the data and information needed to support the issuance of an 
EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an 
investigational vaccine to prevent COVID-19. Although, the guidance 
stated that it was intended to remain in effect only for the duration 
of the public health emergency related to COVID-19 declared under the 
Public Health Service Act, in the Federal Register of March 13, 2023 
(88 FR 15417 at 15421), FDA listed the guidance as one of the COVID-19-
related guidances the Agency was revising to continue in effect for 180 
days after the COVID-19 public health emergency declared under the PHS 
Act expired on May 11, 2023, during which time FDA planned to further 
revise those guidances. However, circumstances have changed since the 
end of the declared public health emergency on May 11, 2023. FDA has 
reviewed the Vaccine EUA guidance and determined that the guidance is 
no longer needed, as the Agency has shifted its focus toward 
communicating directly with individual manufacturers. Accordingly, the 
EUA guidance will no longer be in effect after the publication of the 
guidance for immediate implementation announced in this notice, 
``Development and Licensure of Vaccines to Prevent COVID-19.''

IV. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: October 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23162 Filed 10-19-23; 8:45 am]
BILLING CODE 4164-01-P