Notice — Revocation of the Janssen COVID-19 Vaccine Authorization (Federal Register, October 15, 2024)
Summary
Federal Register, Vol. 89, No. 199, Tuesday, October 15, 2024, Notices, page 83021. It carries a Food and Drug Administration notice, Docket No. FDA–2021–N–0335, titled Revocation of Emergency Use of a Biological Product During the COVID–19 Pandemic; Availability, which announces that FDA revoked the Emergency Use Authorization issued to Janssen Biotech, Inc. for the Janssen COVID-19 Vaccine on June 1, 2023. It states that notice of the revocation in the Federal Register was inadvertently delayed. The notice reprints a June 1, 2023 letter on the request Janssen made on May 22, 2023, and revokes EUA 27205 under section 564(g)(2)(C) of the Act. The same pages also carry notices on a priority review voucher for AQNEURSA (levacetylleucine) and on functional statements for the Office of Policy and Planning.
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“Notice — Revocation of the Janssen COVID-19 Vaccine Authorization (Federal Register, October 15, 2024).”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/federal-register-89-fr-83021-oct-15-2024-revocation-of-the-janssen-eua-9f83992d75/
, SHA-256 2ba1a6c3fb41ca37368842ca659273994f0b95a833688a4ebe035d04422a3316.Full text
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83021
Dated: October 8, 2024. for electronic access to the of, and on June 1, 2023, FDA revoked,
Eric Flamm, Authorization. the Authorization for the Janssen
Acting Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: COVID–19 Vaccine. Janssen notified
[FR Doc. 2024–23646 Filed 10–11–24; 8:45 am] Tami Belouin, Center for Biologics FDA that the last lots of the Janssen
BILLING CODE 4164–01–P Evaluation and Research, Food and COVID–19 Vaccine purchased by the
Drug Administration, 10903 New U.S. Government have expired, that
Hampshire Ave., Bldg. 71, Rm. 7301, there is no demand for new lots of the
DEPARTMENT OF HEALTH AND Silver Spring, MD 20993–0002, 240– Janssen COVID–19 Vaccine in the
HUMAN SERVICES 402–7911. United States, and that it does not
SUPPLEMENTARY INFORMATION:
intend to update the strain composition
Food and Drug Administration of this vaccine to address emerging
[Docket No. FDA–2021–N–0335]
I. Background variants. Based on FDA’s understanding
Section 564 of the FD&C Act (21 that Janssen does not intend to offer the
Revocation of Emergency Use of a U.S.C. 360bbb–3) allows FDA to Janssen COVID–19 Vaccine in the
Biological Product During the COVID– strengthen the public health protections United States under the EUA anymore
19 Pandemic; Availability against biological, chemical, nuclear, and Janssen’s request that FDA revoke
and radiological agents. Among other the EUA for the Janssen COVID–19
AGENCY: Food and Drug Administration,
things, section 564 of the FD&C Act Vaccine, FDA has determined that it is
HHS. appropriate to revoke this Authorization
allows FDA to authorize the use of an
ACTION: Notice. to protect the public health or safety.
unapproved medical product or an
SUMMARY: The Food and Drug unapproved use of an approved medical
III. The Revocation
Administration (FDA or Agency) is product in certain situations. On
announcing the revocation of the February 27, 2021, FDA issued an Having concluded that the criteria for
Emergency Use Authorization (EUA) Authorization (EUA 27205) to Janssen revocation of the Authorization under
(the Authorization) issued to Janssen for the Janssen COVID–19 Vaccine, section 564(g)(2)(C) of the FD&C Act are
Biotech, Inc. (Janssen), for the Janssen subject to the terms of the met, FDA has revoked the EUA for the
COVID–19 Vaccine. FDA revoked the Authorization. Notice of the issuance of Janssen COVID–19 Vaccine. Although
Authorization on June 1, 2023, under the Authorization was published in the FDA revoked the Authorization for the
the Federal Food, Drug, and Cosmetic Federal Register on May 27, 2021 (86 Janssen COVID–19 Vaccine on June 1,
Act (FD&C Act). The revocation, which FR 28608), as required by section 2023, as was publicly announced on the
includes an explanation of the reasons 564(h)(1) of the FD&C Act. Subsequent Agency’s website, publication of notice
for the revocation, is reprinted in this updates to the Authorization were made of this revocation in the Federal
document. available on FDA’s website. The Register was inadvertently delayed. The
authorization of a biological product for revocation in its entirety follows and
DATES: The Authorization is revoked as emergency use under section 564 of the
of June 1, 2023. provides an explanation of the reasons
FD&C Act may, pursuant to section for revocation, as required by section
ADDRESSES: Submit written requests for 564(g)(2) of the FD&C Act, be revoked 564(h)(1) of the FD&C Act.
a single copy of the revocation to the when the criteria under section 564(c) of
Office of Communication, Outreach and the FD&C Act for issuance of such IV. Electronic Access
Development, Center for Biologics authorization are no longer met (section
Evaluation and Research, Food and 564(g)(2)(B) of the FD&C Act), or other An electronic version of this
Drug Administration, 10903 New circumstances make such revocation document and the full text of the
Hampshire Ave., Bldg. 71, Rm. 3128, appropriate to protect the public health Authorizations and revocation are
Silver Spring, MD 20993–0002. Send or safety (section 564(g)(2)(C) of the available on the internet at https://
one self-addressed adhesive label to FD&C Act). www.fda.gov/emergency-preparedness-
assist that office in processing your and-response/mcm-legal-regulatory-
request or include a Fax number to II. EUA Revocation Request and-policy-framework/emergency-use-
which the revocation may be sent. See In a request received by FDA on May authorization.
the SUPPLEMENTARY INFORMATION section 22, 2023, Janssen requested withdrawal BILLING CODE 4164–01–P
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83022 Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
FOOD DRUG
June 1, 2023
Janssen Biotech, Inc.
Attention: Ms. Ruta Walawalkar
92.0 Route 202
Raritan, NJ 08869
Re: Revocation of EUA 27205 ~ Janssen COVID-19 Vaccine
Dear Ms. Walawalkar:
This letter is in response to the request from Janssen Biotech, Inc. received on May 22,
2023, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for the
Janssen COVID-19 Vaccine issued on February 27, 2021, as subsequently amended.
Janssen Biotech, Inc has informed the FDA that the last lots of the Janssen COVID-19
Vaccine purchased by the United States Government have. expired, that there is no
demand for new lots of the Janssen COVID-19 Vaccine in the United States, and that
Janssen Biotech, Inc does not intend to update the strain composition of this vaccine to
address emerging variants.
The authorization of a biological product for emergency use under section 564 of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb~3) may, pursuant to
section 564(g)(2) of the Act, be revoked when circumstances make such revocation
appropriate to protect the public health or safety (section 564(g)(2)(C) of the Act).
Because FDA understands that Janssen Biotech, Inc. no longer intends to offer the
Janssen COVID-19 Vaccine in the United States under the EUA and because Janssen
Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19
Vaccine, FDA has determined that it is appropriate to protect the public health or safety
to revoke this authorization.
Accordingly, FDA hereby revokes EUA 27205 for the Janssen COVID-19 Vaccine,
pursuant to section 564(g)(2)(C) of the Act As of the date of this letter, the Janssen
COVID-19 Vaccine is no longer authorized for emergency use by FDA..
Notice of this revocation will be published in the Federal Register, pursuant to section
564(h)(1) of the Act.
Sincerely,
Peter W, Marks-,
s o,..,"''''"''"'
Peter Marks, M.D, Ph.D.
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Director
Center for Biologics Evaluation and Research
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Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83023
Dated: September 27, 2024. Conditions/RarePediatricDiseasePriority Section RM.20 Function
Kimberlee Trzeciak, VoucherProgram/default.htm. For Update the functional statements for
Deputy Commissioner for Policy, Legislation, further information about AQNEURSA the Office of the Associate
and International Affairs. (levacetylleucine), go to the ‘‘Drugs@ Administrator, Office of Policy and
[FR Doc. 2024–23637 Filed 10–11–24; 8:45 am] FDA’’ website at http:// Planning, Division of Healthy Start and
BILLING CODE 4164–01–C www.accessdata.fda.gov/scripts/cder/ Perinatal Services, and Division of
daf/. Home Visiting and Early Childhood
Dated: October 8, 2024. Systems and add the functional
DEPARTMENT OF HEALTH AND statement for the Office of Strategy,
Eric Flamm,
HUMAN SERVICES Innovation, and External Affairs and
Acting Associate Commissioner for Policy.
Division of Women’s Health:
Food and Drug Administration [FR Doc. 2024–23712 Filed 10–11–24; 8:45 am]
[Docket No. FDA–2020–N–0026]
BILLING CODE 4164–01–P Office of the Associate Administrator
(RM)
Issuance of Priority Review Voucher; The Office of the Associate
Rare Pediatric Disease Product; DEPARTMENT OF HEALTH AND
Administrator provides national
AQNEURSA (Levacetylleucine) HUMAN SERVICES
leadership and policy direction for
AGENCY: Food and Drug Administration, Health Resources and Services MCHB programs. These programs are
HHS. Administration designed to improve the health of
women of childbearing age, infants,
ACTION: Notice.
Statement of Organization, Functions, children, adolescents and their families,
SUMMARY: The Food and Drug and Delegations of Authority children with special health needs, and
Administration (FDA) is announcing the persons with hemophilia. Specifically,
This notice amends Part R of the the Office: (1) coordinates the planning,
issuance of a priority review voucher to
Statement of Organization, Functions, development, implementation, and
the sponsor of a rare pediatric disease
and Delegations of Authority of the evaluation of MCHB’s programs and
product application. The Federal Food,
Department of Health and Human activities; (2) facilitates effective,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review Services (HHS), Health Resources and collaborative relationships with other
vouchers to sponsors of approved rare Services Administration (HRSA) (60 FR health and related programs; (3)
pediatric disease product applications 56605, as amended November 6, 1995; establishes program mission, goals,
that meet certain criteria. FDA is as last amended at 89 FR 19832 dated objectives, and policy with broad
required to publish notice of the award March 20, 2024) to reorganize sections Administration guidelines; (4) arranges
of the priority review voucher. FDA has of the Maternal and Child Health and provides technical assistance to
determined that AQNEURSA Bureau (MCHB). ensure that grantees meet program
(levacetylleucine), approved on This reorganization updates and/or expectations; (5) serves as principal
September 24, 2024, manufactured by realigns functions, including contact point across HRSA, HHS, and
IntraBio Inc., meets the criteria for a delegations of authority for MCHB (RM). other agencies on matters concerning
priority review voucher. Chapter RM—Maternal and Child the health status of America’s mothers
FOR FURTHER INFORMATION CONTACT: Health Bureau (RM) and children; and (6) provides
Cathryn Lee, Center for Drug Evaluation information and reports on MCHB’s
Section RM.10 Organization programs to Congress, other federal
and Research, Food and Drug
Administration, 10903 New Hampshire Establish the Office of Strategy, agencies, the public, and other
Ave., Silver Spring, MD 20993–0002, Innovation, and External Affairs and the stakeholders.
301–796–1394. Division of Women’s Health. Office of Policy and Planning (RMA)
Following this realignment, MCHB
SUPPLEMENTARY INFORMATION: FDA is The Office of Policy and Planning
includes the following components:
announcing the issuance of a priority
• Office of the Associate serves as MCHB’s focal point for the
review voucher to the sponsor of an development of MCHB policy and
Administrator (RM),
approved rare pediatric disease product • Office of Policy and Planning program planning. Specifically, the
application. Under section 529 of the (RMA), Office: (1) supports the Office of the
FD&C Act (21 U.S.C. 360ff), FDA will • Office of Strategy, Innovation, and Associate Administrator in identifying,
award priority review vouchers to External Affairs (RMB), planning, and implementing policy and
sponsors of approved rare pediatric • Office of Operations and program priorities across MCHB; (2)
disease product applications that meet Management (RM1), advises and assists in the development,
certain criteria. FDA has determined • Division of Services for Children coordination, and management of
that AQNEURSA (levacetylleucine), with Special Health Needs (RM2), program and policy documents and
manufactured by IntraBio Inc., meets • Division of Child, Adolescent, and responses to departmental and HRSA
the criteria for a priority review Family (RM3), initiatives; and (3) coordinates with
voucher. AQNEURSA (levacetylleucine) • Division of Maternal and Child other components within HRSA, HHS,
is indicated for the treatment of Health Workforce Development (RM4), federal agencies, state and local
neurological manifestations of • Division of Healthy Start and governments, and other public and
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Niemann-Pick disease type C in adults Perinatal Services (RM5), private organizations on issues affecting
and pediatric patients weighing ≥15 kg. • Division of State and Community MCHB programs and policies.
For further information about the Rare Health (RM6),
Pediatric Disease Priority Review • Division of Home Visiting and Early Office of Strategy, Innovation, and
Voucher Program and for a link to the Childhood Systems (RM8), External Affairs (RMB)
full text of section 529 of the FD&C Act, • Office of Epidemiology and The Office of Strategy, Innovation,
go to https://www.fda.gov/ForIndustry/ Research (RM9), and and External Affairs serves as MCHB’s
DevelopingProductsforRareDiseases • Division of Women’s Health (RMC). focal point for strategic planning,
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