Notice2023-23162
Development and Licensure of Vaccines To Prevent COVID-19; Guidance for Industry; Availability
Primary source
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Published
October 20, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 202 (Friday, October 20, 2023)</title>
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[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72489-72491]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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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
<a href="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/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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</html>Indexed from Federal Register on October 20, 2023.
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