Authorization of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability, 52790-52801 [2022-18527]
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18517 Filed 8–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
countermeasure priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
application for MOUNJARO
(tirzepatide) injection, approved May
13, 2022, meets the redemption criteria.
For further information about the
Material Threat Medical
Countermeasure Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions. For further
information about MOUNJARO
(tirzepatide) injection, go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: August 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[Docket No. FDA–2019–N–0895]
[FR Doc. 2022–18523 Filed 8–26–22; 8:45 am]
Notice of Approval of Product Under
Voucher: Material Threat Medical
Countermeasure Priority Review
Voucher
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
Notice.
[Docket No. FDA–2021–N–0335]
The Food and Drug
Administration (FDA) is announcing the
approval of a product redeeming a
priority review voucher. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the 21st Century
Cures Act, authorizes FDA to award
priority review vouchers to sponsors of
a material threat medical
countermeasure application that meets
certain criteria upon approval of such
application. FDA is required to publish
notice of the issuance of priority review
vouchers as well as the approval of
products redeeming a priority review
voucher. FDA has determined that the
application for MOUNJARO
(tirzepatide) injection, approved May
13, 2022, meets the redemption criteria.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–8515 (this is not
a toll-free number), email: EUA.OCET@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a), which was added by
section 3086 of the 21st Century Cures
Act (Pub. L. 114–255), FDA will report
the issuance of material threat medical
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Authorization of Emergency Use of a
Biological Product During the COVID–
19 Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) for use during
the COVID–19 pandemic. FDA has
issued one Authorization for a
biological product as requested by
Novavax, Inc. The Authorization
contains, among other things,
conditions on the emergency use of the
authorized product. The Authorization
follows the February 4, 2020,
determination by the Secretary of Health
and Human Services (HHS) that there is
a public health emergency that has a
significant potential to affect national
security or the health and security of
U.S. citizens living abroad and that
involves a novel (new) coronavirus. The
virus, now named SARS–CoV–2, causes
the illness COVID–19. On the basis of
such determination, the Secretary of
HHS declared on March 27, 2020, that
SUMMARY:
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circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to the
FD&C Act, subject to the terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
DATES: The Authorization is effective as
of July 13, 2022.
ADDRESSES: Submit written requests for
a single copy of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4340, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help ensure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives (among other criteria).
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
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or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, U.S.
Code, of attack with (A) a biological,
chemical, radiological, or nuclear agent
or agents; or (B) an agent or agents that
may cause, or are otherwise associated
with, an imminently life-threatening
and specific risk to U.S. military
forces; 1 (3) a determination by the
Secretary of HHS that there is a public
health emergency, or a significant
potential for a public health emergency,
that affects, or has a significant potential
to affect, national security or the health
and security of U.S. citizens living
abroad, and that involves a biological,
chemical, radiological, or nuclear agent
or agents, or a disease or condition that
may be attributable to such agent or
agents; or (4) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d–6b) sufficient
to affect national security or the health
and security of U.S. citizens living
abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. Section
564 of the FD&C Act permits FDA to
authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use in
an actual or potential emergency when
the Secretary of HHS has declared that
circumstances exist justifying the
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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authorization of emergency use.
Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
sections 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
and 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 2 concludes: (1) that an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that: (A) the
product may be effective in diagnosing,
treating, or preventing (i) such disease
or condition; or (ii) a serious or lifethreatening disease or condition caused
by a product authorized under section
564, approved or cleared under the
FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating,
or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of
the product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii) of the FD&C
Act, that the request for emergency use
is made by the Secretary of Defense; and
(5) that such other criteria as may be
prescribed by regulation are satisfied.
No other criteria for issuance have
been prescribed by regulation under
section 564(c)(4) of the FD&C Act.
2 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
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52791
III. The Authorization
The Authorization follows the
February 4, 2020, determination by the
Secretary of HHS that there is a public
health emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves a novel
(new) coronavirus. The virus, now
named SARS–CoV–2, causes the illness
COVID–19. Notice of the Secretary’s
determination was provided in the
Federal Register on February 7, 2020
(85 FR 7316). On the basis of such
determination, the Secretary of HHS
declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to
section 564 of the FD&C Act, subject to
the terms of any authorization issued
under that section. Notice of the
Secretary’s declaration was provided in
the Federal Register on April 1, 2020
(85 FR 18250). Having concluded that
the criteria for issuance of the
Authorization under section 564(c) of
the FD&C Act are met, FDA has issued
the authorization for the emergency use
of a biological product during the
COVID–19 pandemic. On July 13, 2022,
FDA issued an EUA to Novavax, Inc. for
the biological product Novavax COVID–
19 Vaccine, Adjuvanted, subject to the
terms of the Authorization. The initial
Authorization, which is included below
in its entirety after section IV of this
document (not including the authorized
versions of the fact sheets and other
written materials), provides an
explanation of the reasons for issuance,
as required by section 564(h)(1) of the
FD&C Act. Any subsequent reissuance
of the Authorization can be found on
FDA’s web page at: https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization.
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorization is available on the
internet at: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
U.S. FOOD & DRUG
ADM INISTIV\ti ON
July 13, 2022
Novavax, Inc.
Attention: Ms, Kathleen Callahan
21 Firstfi eld Rd
Gaithersburg, MD 20878
Dear Ms. Callahan:
This 1etter is in response to a: request from Novava.x, Inc. that the Food and Drug Administration
(FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Novavax
COVID-19 Vaccine, Adjuvanted :for the prevention of Coronavirus Disease 2019 (COVlD-19)
for individuals. J8 years of age and older, as described in the Scope of Authori71ttion (Section TI)
of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act{the FD&C
Act or the Ac() {21 US.C. 360bbb~3).
Oh February 4, 2020, pursuant to Section564(b)(l)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that thete is a public health
emergency that has a significant potential to affect national security or the health and securify of
United States citizens living abroad, and that involves the vims that causes COVID-19, 1 On the
basis of' such determination, the Secretary oPHHS on March 27, 2020, declared that
circumstances exist Justifying the authorization of emergency use of drugs and biological
products during the COVID-19 pandemic, pursuanJ to Section 564 of the Act, subjecttoterms of
any authorizatitm issued under that section. 2
The Novavax COVID-19 Vaccine, Adjuvanted is for active immunization to prevent COVID-19
caused by severe acute respiratory syndtome coronavtrus 2 (SARS•CoV--2) inindividuals 18
years of age and older; The vaccine contains a recombinant spike (rS) protein, and saponirt'based adjuvant,_ Matrix-M. The Novavax. COVlD-19 Vaccine, Adjuvanted is.an investigational
vaccinenot licensed for any indication.
FDA reviewed safecy and efficacy datafrotn an ongoing phase 3 trial in which participants 18
years ofage and older were randomized 2; 1 to receive two dose$ of Novavax COVID-19
Vaccine~ Ad]uvanted or placebo, 3 weeks apart; This study includes pre.crossover and post•
crossover periods. Tn the pre-crossover period, I 9,735 participants received Novavax COVID 19
Vaccine, Adjuvanted and 9,847 received saline placebo. In the post-crossover period, 6A 16
0
1 US. Department ofIIeal:th and IIU'ihan Sen,ice1>, Dete1tnina:fion.•of a: Pt1blidiealth Emergency and Declaration that
Cfrcumsamccs Exist Justifying Authm17ations Pursua11t tn Section 564(h) of the Federal Food, Dtug, .and Cosmetic
Act, 21 U.S.C § 360bbb-3. Februruy 4, 2020.
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1 U.S. Departrnent.ofHealth and Human Services,Declaration that Circumstances Exist Justifying Authorizations
Pursuantto Section564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.s.t. § '.360bb~3, 85 FR 18250 (April
1,1020).
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
52793
Page 2 - Novavax, Inc.
participants received Novavax COVID-19 Vaccine, Adjuvanted and 15,298 received saline
placebo. Of participants who received two doses ofNovavax COVID-19 Vaccine, Adjuvanted
i11 the pre-crossover period (n==19, 111), 78% had a follow-up duratio11 of at least 2 months
(median= 2.5 mo11ths) after Dose .2. Of the participants who received two doses ofNovavax
COVID-19 Vaccine, Adjuvanted in the post-crossover period (n= 6,346), 99% had a follow-up
duration of at least2 months(median = 4.4 months)afterthe last dose. FDA's review
considered the safety and effectiveness data as they relate to the request for emergency use
authorization, and did 110t identify specific safety concerns that would preclude issuance of an
EUA. FDA's analysis of the efficacy data. from 25,657 participants 18 years of age a11d older
who did not have evidence of SARS-Co V-2 infection through 6 days after the second dose and
who had a median follow-up of2.5 months after Dose 2 during the pre-crossover period shows
that the vaccine was 90.4% effective (95% confide11ce interval (CI): 83.8%, 94.3%) in
preventing PCR-co11firmed symptomatic mild, moderate, or severe COVID-.19 occurring at least
7 days after Dose 2. Based on these data, and the review of manufacturing infom1ation regarding
product quality and consistency, it is reasonable to believe that the Novavax COVID-19 Vaccine,
Adjuvanted may be effective. Additionally, it is reasonable to conclude, based 011 the totality of
the scie11tific evidence available, that the known and potential benefits of the Novavax
COVID-19 Vaccine, Adjuvru1ted outweigh its know11 a11d potential risks for the preve11tio11 of
COVID-19 in individuals 18 years of age and older. Finally, on June 7, 2022, the Vaccines and
Related Biological Products Advisory Committee voted in agreement with this conclusion.
Having concluded that the criteria for issuat1ce of this authorization under Section 564(c) of the
Act are met, I atn authorizing the emerge11cy use of the Novavax COVID-19 Vaccine,.·
Adjuvanted for the prevention ofCOVID-19.as described in the Scope of Authotization secti.011
of this letter (Section II) and subject to the tem1s of this authorization.
I.
Crite1ia for Issuance of Authorization
I have concluded that the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted, for
the prevention ofCOVID-19 when administered as described in the Scope of Authorization
(Section II) meets the criteria :for issuance of atl authorization under Section 564(c) ofthe Act,
because:
·
1) SARS-CoV-2 can cause a setious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this vims;
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2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that the Novavax COVID-19 Vaccine, Adjuvanted may be effective in preventing
COVID-19, and that, when used under the conditions described in this authorization,
the known and potential benefits of the Novavax COVID-19 Vaccine,. A(ljuvanted
when used to pt·event COVID-19 outweigh its known and potential risks; and.
52794
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
J>age 3 -Novavax, Inc.
3) There is•no adequate, approved, and.available altemative 3 to the emergency use ofthe
Nova:vaxCOVID-19 Vaccine, Adjuvantedto prevent COVID-19. 4
n.
·Sci:tpe o(Authorization
[have concluded, pursuant to Section 564(d)(l)ofthe Act; thatthe s.cope ofthis authorization is
limited as follows:
•
will supply the Ncrvavax cOVJ:0~19 Vitccine, Adjµvanted through
a:uthoriz:ed_distributor(s) 5 to emergency response stak:eholders6 direct:edl:iy the
Novavax, Inc;
as
U.$. government,. in,clu(Jing the Centei-s for Disease Control and Prevention
•
(CDC) and/or other designee, for use consistent with the terms. and conditions of
thisEUA;
TheNovavaxCOVID-19Va:ccirie, Adjuvanted coveted by this authorizatioii will
be adtrtmistered by vaccination providers7 and used only to prevent COVID-19in
'AfthoughSpikev!lX(CQVID·l9V:ac<;ine;mRNA,)and,Comima!Y'(COVID•WViiccfoe;triRNA)ateappi:ovedtoprevent
COVIIF1.9inindividuals\VithinthesoopeofiheNovavax.covm.19Vaccine;Adjuvantedauthotlzation,ihetearenot
gofficientquantiiies of approved vaccirte available for dislribulion to this poptil.a:titin in its entirety at the titne ofrei~stllltlce
of this EVA. In aclditionJhis vaccine maybe llil alternative.for individuals forwhom the: approvedti!RNA COVIDi 9'vaccines are contraindicate&
4 Nu
other criteria of issuance havJ:. been prJ:scribooby regulation under Section 564(;X4) of the Act:
5 ''Authori:zed Distn"butor(s)"ateiderttifiedby Novi'lV'ax; Inc,. or; ff applicable; by a tls. govemmertt.entity; such as
the Centers for bisel!SeContr:ol at)d ~vention.(CDC}l!Ild!or otherdesignee,as an entity ot entitieiniilowedto
4lstribute authori~d.Novaval' COVID-19 Vaccille, Adjuvanted.
6 Forpurposes oftliisJelter,
"emergency response stakeholder'' refersl9 a public health agency l!Ildits delegates that
havelegai responsibility and authority for responding to llil incident; based on politfoal:or geographical boundary
lines.(e.g., city, county,.tribal,territorial, State; or Fed€:ral); or functional (e.g., lawenforcement orpublic health
range) or sphere-of authority to adtnini$r, delive:r; or distrimite vaccine iru111 emei:gency situation. In sqme <;ases
(e,g,. depending on a state or localjurisdiclion's COVID-19 vaccination response organization and plans), there
might be overlapping roles and responsibilities among "emergency response stakeholders" ·and "vaccination
providm"(e.g:,_ ifa local.health department is adtninistering COVID-19 v.iccines; if a phanna<;y is a<;ting in an
official capacity under tire iiuthority of the state health. department fo adtninisterCOV:TI)c, 19 vaccines), In such cases,
it is eiq,ect.ed that the conditions ofauthotization that apply to. em etgency response stakeholders and vaccination
prqvid:er'l! wlll all beiMt
..
.
For purpqses of this t~r; ''v11;ccinatfort pi:oVider'' refers t◊ thefi1<:ility; otganiZation; or he~lthcai:e provider
Hcegsed or· othetwise·au!hori:zed by thewiergency•t~pollJie stalteholder(e,g., nort0physician healthcai:¢
professionals; such:as iiutscs:and phaim acists pursuant. to state liiw under a standing orderissued by the ·state lieilth
officet).to adm:iriist.et :or provide: -vac¢ination services iii ilccqrdlin.ce with the aj,plicapfo emergency rer;pons11 ...
stakeholclet's:officia!COV1D0 l9vaccination ande11.1etgertcyresponi;epl(Ul.(s)at1d who is enrnlled in the COO
COVU?-19-V:a.:cmatioii '.Pt0grart1. Jf the vaccineiis exportedJrom the United States, a ''yoocinatibn'providet" is a
proyidet.that is a:uthorized to a:dlnin1mr this vaccine in accor<funcewith the laws ot'the country incwliichjds
adniltji$tett\d For pun,oses pfthi.$ Jett.er, "hei.t!thcare p,ovidel"' ~lso refers to. il person.authorize~ by the p .S;
Depa:rttnent"()fllealthmid_ Huirian $tir'Vice$ (e.g., under.the PREP Act beciaratioitfor :MedicalCountetrneasures
against COVID-19) io administer FDA a\.rlhori~d CbVID~l 9 Vllccine (e.g:, qillllified pharmacy tcchn1cians and
State-i!Uthqrizedphannacy intei:rts.actiiig url<ler.tli,~su~rvisiqnofii-qualified phannacist): see, e.g.,Jrns: fqurt!t
Amen~ent to th~ Declaration [[nder theP1ibl/c ReadinessantJ:Jlm~rgency Preparedries~ActfqrMedical
CountermeasuresAgatnstCOV1Dc19 ondR.epubiwaiton ofthe r>eclaration. RS FK79'19Q(Deceruber 9; 202◊).
7
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
52795
Page 4 ~ Novavax, Inc.
•
individuals ages 18 and older with a two-dose primary series given 3 weeks
apart; and
The Novavax COVID-19 Vaccine, Adjuvanted may be administered by a
vaccination provider without an individual prescription for each vaccine
recipient.
Product Description
The Novavax COVID-19 Vaccine, Adjuvanted is supplied as a suspension in multi-dose vials.
The Novavax COVID-19 Vaccine, Adjuvanted does not contain a preservative.
The primary series is two doses (0.5 mL each) given 3 weeks apart.
Each 0.5 mL dose of the Novavax COVID-19 Vaccine, Adjuvanted is fonnulated to contain
5 mcg of SARS-Co V-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant. The
Matrix M ac'tjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) ofsaponin
ex1racts from the soapbark tree, Quillaja saponaria Molina. Each dose of the Novavax COVID19 Vaccine, Adjuvanted also includes the following ingredients: cholesterol (30.5 mcg),
phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride
(2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate
heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium
chloride (8.856 mg), and polysorbate 80 (0.05 mg) in sterile Water for Injection. 'The pH is
adjusted with sodium hydroxide or hydrochloric acid.
Ihe manufacture ofthe authorized Novavax COVID-19 Vaccine, Adjuvanted is limited to those
facilities identified and agreed upon in Novavax Inc. 's request for authorization.
The Novavax COVID-19 Vaccine, Adjuvanted vial label and carton labels are clearly marked for
"Emergency Use Authorization." The Novavax COVID-19 Vaccine, Adjuvanted is authorized
to be distributed, stored, further redistributed, and administered by emergency response
stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons),
despite the fact that the vial and carton labels may not contain infom1ation that otherwise would
be required under the FD&C Act.
VerDate Sep<11>2014
•
Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):
Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted
to Prevent Coronavirus Disease 2019 (COVID-19)
•
Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the
Novavax COVID-19 Vaccine, Adjuvanted to Prevent Coronavirus Disease 2019
(COVID-19)
17:01 Aug 26, 2022
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The Novavax COVID-19 Vaccine, Adjuvanted is authorized for emergency use with the
following product-specific information required to be made available to vaccination providers
and recipients, respectively (referred to as "authorized labeling"):
52796
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
lhave-concluded, pursuanUoSection. 564(d)(2) ofthe Act, that itis reasonableto believe that
the known andpotentialbenefrts ofthe.Novavax COVID-19 Vaccitte, Adjuvanted, when. usedto
pteventCOVIO.i9'andus¢dln accor~ce With this Scope ·ofAuthbcizatfon(S®tionll);.
Qut\\leigh its known and p.ot¢ntial risksi
·
·
[have concluded, pursuanltoSeclion 564(d)(;3)ofthe Acl;based on the totality ofscieritific
evidence available to FPA, thatitis reasortli'.bietQbelieve thatthe Novavax.C()VII);t9Vii:cclne,
Adjuvanted.rnay be:effective irt pteventing COVIP-19. when'U$ed irt :accordartcewJththis·Scope
ofAuthorization($:ec:fi011 it); pursuant.to Section: 564(<:)(2)(A) ofthe')\ci;
·
Havingreviewed.the s.cieritific infonnation•availiiblefoFDA,fucludinglheinfonnation
66~~1~:c::.:~1::~~~:!:~!t~:~::;i:i::;~~:ri»:!oots.
th'!l criteria; s(ll;fot1Jrln S~t>n564{p) of:'the Aqtlolqncem.m11~ety an4p~a-l~c:fiveneS$,
Toe emergeric.yiise ofllieNovavaxcovrn~19:vaccine,AdJuvatrted uridetthisEUAmustbe
r:=ati~S~~r:::=J:;::~!:::t':tl:~~f!je~th:ftetmsof
~t:rlliriation
un,<ler
decfuration·under
tlii& EUA an.d01Uidei<tJi,e"c~ces setfortll itt theiS~'QIJll:l~'s
Section 564{bXlXC)describediibove andthe, Secretary ofHHS~s corresponding
;5*,:,::::~':':~~~hyll)
section 564(b)(l),theNovaYax COVII);19 vaccme, AdjuvantedJs authorized to prevent~COVI0-
nt
·conditions otAitthodzati.on
~uant IQ Secfi011 5t34.of~ Act.l®t'~lishinJtlie fqlfoWli)g•l::@4itiQflS' onthis!il@orl.zatl.on,
Novavax;Jnc; andAuthorized Distributorj'.s}
and
::!f:stt=inationptovi~,.recipien:ts~,andcaregivers,consistent•with.
A 'Novavax,:Inc. .
authorized distributor(s)·witt ensute thaf•the iitiiliotized Novlt'Vax
COVI1}- l?¥iwi::irte;.Adjt1Yli11te<l i f f ~ ~ as·dir:ecte1ll,yilteV,~- gov.ernment;
includiilgCDC.·and/orotherdesignee;·•andthe authorized•Iiibelittg-(i;e"'Fact•·Sheefs)is
B. 1',l'oya~Jn:i::, ~ru,fauthorized lii$".l"bl(tor(s)will ensure that appropriate sto~;;: and
cold chain is maintaineduntil delivered to emergency response stakeholders' receipt
sites,
ct ~N'ovavax. hi:c. will en,sUre-tlraitberterfmi:<>fthifltQAiliii'made avait®le:to all
relevailtstili:holders (e,g,,·emergencyresponse stilkehol~•. autfu>rizeddistributors,
.and.vaccfuationproviders)•involved•in·distriblitfugor,receiviilg,the.·authorized
Nova.vex covrn~.19 Vaccine,Adjuvantett Novavax,Jnc, will provide tb attreievant
VerDate Sep<11>2014
17:01 Aug 26, 2022
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Stiilwholdets•.aCO{>YOfthis·tetterofauthorizationandconununicawants!lhsl;l(IUertt
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
52797
Page 6 ~ Novavax, Inc.
amendments that might be made to this letter of authorization and its authorized
labeling.
D. Novavax, Inc. may develop and disseminate instructional and educational materials
(e.g., video regarding vaccine handling, storage/cold-chain management, preparation,
disposal) that are consistent with the authorized emergency use ofthe vaccine as
described in the letter of authorization and authorized labeling, withoutFDA's review
and concurrence, When necessary to meet public health needs during an emergency.
Any•instructional and educational materials that are inconsistent with the authorized
labeling are prohibited.
K Novavax,· Inc. may request changes to this authorization, incfoding to the authorized
Fact Sheets for the Novavax CQVII)..19 Vaccine, Adjuvanted. Anyrequestfor
changes to this EUA must be submitted to the Office ofVaccines Research and
Review(OVRRYCenterforBiologics Evaluation and Research (CBER). Such
changes require appropriate authorization prior to implementation. 8
F. Novavax, Im:L wilt report to Vaccine Adverse.Event.ReportingSystetn.(>!AERS):
• Serious adverse events (irrespective ofattribution to vaccinationX
• Cases of Multisystem Inflammatory Syndrome in adults; and
• Cases of COVID-19that result.in hospitalization or death, that are reported to
Novavax,, Inc.
These reports should be submitted to VAERS .as soon as possible but no later than
15 calendar days from initial receipt of the inlonnation by Novavax; Inc,
fr Novavax, Inc. must submit toJnvestigatiortal New Drug .application (IND) number
22430 periodic safety reports at monthly intervals in accordance with a due date agreed
upon with the Office of Biostatistics and Pharmacovigilartce (OBPV)i'CBER,
beginning after the first full calendar month after authorization, Each periodic safety
repo11 is required to contain descriptive infonnation which includes:
• A narrative summary and analysis of adverse events submitted during the reporting
interval, including interval and cumulative counts by age groups, special
populations (e.g., pregnant women), and adverse events of special interest;
• A narrative sum:mary and analysis of vaccine administration errors, whether or not
associated with an adverse event, that were identified since the last reporting
interval;
• Newly identified safety concerns in the interVal; and
The following types of revisions may be authorized without reissuing thls letter: (1) changes to the authorized
labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new
fact sheets;.(4) new cartonfcunfainer.labels; (5) expiration. dating extensions; (6) changes to manufacturing
processes; including tests or other authorized components ofmanufacturing; (7) new conditions ofautharization to
require data collection or study. All changes.to the authorizationrequire review and concurrence from OVRR. For
changes to the authorization, including the authorized labeling, of the type listed in (3),(6), or (7), review and
concurrence is also required from the Preparedness and Response Team (PREP)/Office ofthe Center Director
(OD)/CBER and the Office of Counterterrorism and Emerging threats (OCET)/Office of the Chief Scientist (OCS)s
VerDate Sep<11>2014
17:01 Aug 26, 2022
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8
52798
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
:eage 7 ~ Novayax, Inc,
• Actions~~• s~theJl!Strep<m !,ec1,UJS1:, of lidverst: experiences (fore}{llfflpl.;,
changesmade to Healthcare Providers AdmihisteringVaccine(Vaccination ·
.Providers)Fact Sheet,change&madetQ studies or studies irritiab:d).
ll Jifotihang~ will he inlplen:lentedtothedescripti<>n <>fthe prod1:1cl, manl!factwjng
process~facllities,.or equipmeritwithoutnotificationto and concurrence bythe
Agcmcy.
[ =°!:~g:t®ilhles will comptywith.~GoodManllfacturirtg:)>ractl¢e
J;
N<>vavllX.Jnc. wilJ. ~ubtniH◊the EtJifile Ctitti:ficates Q(Attalysis (QqA):for ~ll
drug product lot atleast 48 hours.prior to vaccine distributiom. The CoAwill include
the··established.specificationsand speciflc•res:ul1Sfor·eachq1.llllny·.oontrohest
petfutmed onthefinal drug product lot
I(, N<rvavax; lrtc, \Vill $Ubniitfothe EUAfile quliitedymanµfa(;turingreports tllat
include alistingofalldrug substance. and srugproduct lots produced after issuance of
this authorizatfort. This report 1:nust include fottrutilbet:, manufactt1tfr1g site, date of'
ma)u.lfactute, and fotdispositipn, includingthi:iselots that wete quatan.tined for
itlyestigation or those fotsthatwererejected. Infotmatiop-0n;thereasomfor fot.
quarantme or rejection must be mcluded.in.the report, The firstreporl i&dUeOctober
13,2022
L,
Nova:v:ax; lnc, and auth:cmzed distribut:or(s)willml:Utltai1t recor& reg11tdntg nile$leof
Nbva:v:a;x: C0\1'1D:.19 Vag<::ii:le, Ailjuvantedfor tij$1til'.lµticm (Le,, Joti,Utnb~;.quantlfy,
release date}
.
..
M...Novavax..Ific;. artdlfuthorized di.sttibutor(s)wl.1itnake•availafitew·F0Aiup.Qrite(ltiest
any·tec◊tdsmaintain.edittCQnnecfion•WiththisEtrA
N. NOvavax,Jnc. will conduct post-authorization observational studies to:evalUlifothe
assbdation betweenNovavaxcovm~ 19 VaccineiA4Juvanted and a pre-specified
listof.adverse·evenwofspeciiilintere~ includingmyocatdnili·antl·petica:rditit "1011.g
with deaths-and hbspitalizattonS; andseyere C0\11D~l9, 11lestudypopulation
shqul<f include indiyiduals administereqtheal.lihorizedNQvav11X:GOVll). t9 Vagcin.e,
Ailjuvanted under thisEUA in the general US; population{18years of age and
old~1popu1ations.dfinterest such.as•healthcare··work.ers,.pregn:antw~
inimunQCblllpromisedindividuals, stibp◊pulati◊rtS with spedticcomorl>i~. The
sl:Qdies sh:Qu1dbe comtutj:ed hi farge ~e ~aseii withan!icliye ~ p ~ .
Novavax,Inc.. willprovide protocolsandstafus update·reportstothe1Ni122430with
agreed,uponstudydesigns and milestone dates.
.ffinemenc:v··Respgnse·Stakeholdera
VerDate Sep<11>2014
17:01 Aug 26, 2022
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0. Emergency response stakeholders will identifyvaccinationsitesto receive authorized
Novavax COV.ID-19 Vaccine,Adjuvantedand ertSure its distribution and
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
52799
Page 8 Novavax, Inc.
administration, consistent with the tenns of this letter and CDC's COVID-19
Vaccination Program.
P. Emergency response stakeholders will ensure that vaccination. providers within their
jurisdictions are aware ofthis letter of auth9rization, l\Ild the tenns herein and any
subsequent amendments that might be made to the letter ofauthorization; instruct
them about the means through which they are to obtain and. administer the vaccine
under the EUA, ai)d ensure that the authorized labellng[i.e., Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers)and .E'act Sheet for
Recipients and Caregivers] is made available to vaccination providers through
appropriate means (e.g., e-mail, website).
Q. Emergency response stakeholders receiving authorized Novavax COVID-19
Vaccine, Aqjuvantedwill ensurethatapproptiate storage and cold chain.is
maintained.
Vacciniltfon Providers
R. Vaccinatfo11 providerswill adtninisterthti vaccine in accordance with the.
authorization and will participate and comply with the terms and training required by
CDC's COVID-19Vaccination Program.
S. Vaccination providers will provide the Fact Sheet for Recipients an.d Caregivers to
each individuaheceiving vaccination and provide the necessary infomtationfor
receiving their second dose.
T. vaccination providers adntinistering the Novavax COV"ID-19 Vaccine, Adjuvanted
mustreport the following information associated with the adtllUlistratjon ofthe
Novavax COVID-19 Vaccine,Adjuvanted of which they become aware to VAERS
in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine
(Vaccination Providers):
• Vaccine administration errors whether or not assodated with an adverse event
• Serious adverse events (irrespective of attribution to vaccination)
• Cases of Muttisystem Inflammatory Syndrome in adults
• Cases of COVID-19 that rel,ult in hospitalization or death
Complete mtd submit reports to VAER:S online at
https://vaets.hhs.gov/reportevent.html. The VAERS reports should include the
words "NovavaxCOVID-19 Vaccine, Adjuvanted EUA'' h1 the description section
of the report. More infomiation is available at vaers.hhs.gov or by calling 1~80082207967; To the extent feasible,reportto Novavax, Inc. by contacting 1-844•
668-2829 or by providing a copy of the VAERS form to Novavax, Inc.; Fax: 1888-988-8809.
VerDate Sep<11>2014
17:01 Aug 26, 2022
Vaccination providers will condu<li any follow-up requested by the tr.~,
govern:ment, including CDC, FDA, or other designee, regarding adveri;e events to
the extentfeasible given the .emergency circumstances.
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tr,
52800
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
Page 9 - Novavax, Inc.
V. Vaccination providers will monitor and comply with CDC and/or emergency
response stakeholder vaccine management requirements ( e,g., requirements
concerning obtaining, tracking, and handling vaccine) and with requirements
concerning reporting of vaccine administration data to CDC.
W. Vaccination providers will ensure that any records associated with this EUA are
maintained until notified by FDA. Such records will be made available fo CDC,
and FDA for inspection upon request.
Conditions Related to. Printed Matter, Advertising, and Promotion
X. All descriptive printed matter, advertising, and promotional niateriat relating to the
use of the Novavax COVlD-19 \'lll,'Cine, Adjuvanted shall be consistentwith the
authorized labeling, as well asihe terms set forth in this EUA, and meet the
requirements set forth in section 502(a) and (n) of the FD&C Act and FDA
implementing regulations.
Y. All descriptive printed matter, advertising, and promotional material relating to ihe
use ofthe Novava,'!: COvlD-19 Vac.,,ifie, Adjuvanted dearly and conspicuously shall
state that:.
• 1lns product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019(COVID-19) for use in individnals 18 years of age and older; and
• 1he emergency use of this product is only authorized for the duration ofthe
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(l) of the FD&C Act unless the
declarationis terminated or authorization revoked sooner.
VerDate Sep<11>2014
17:01 Aug 26, 2022
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Condition Relatedto Export
Z. lfthe NovavaxCOvlD-19 Vaccine,A<ljuvanted is exported:from1:he United States,
conditions C, D, and Othrough Y do not apply, but export is permitted only if l)the
regulatory authorities ofthe country in which the vaccine will be used are fully
informed that this vaccine is subject to li1l EUA and is not approved or licensed by
FDA and 2) the intended use.ofthe vaccine will comply in all respects with the laws
ofthe country in which the product will be used. Toe requirement in this letter that
the authorized labeling (ie., Fact Sheets) be. made available to vaccination providers,
recipients, and caregivers in condition A will not apply if the authorized labeling.
(i.e., Fact Sheets) are made available to the regulatory authorities.ofthe country in
which the.vaccine will be used.
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
52801
Page 1() - J'.ifovavax,Jnc,
IV.
])imttfon..ofAuthorization
this EDA willbe effective uniilthe ded.u-ation that circumstanc~ existjµstifying the
authwization ofthe emergency use ofdrugs and Wological Pr<>dt1CW dlllingthe COVID~ l9
pandemicisterminatedunderSection:564(b)(2)ofthe Act orthe>EUAis revokedunder Section
564(g) 9ftheAct
/Iii
Jacquefute.A, 9':Sltauglr\iessy, ]>n,.I)..
Acting ChiefScientist
Food. andDtugAdministratiori:
Ehcfosures
investigational drug. The draft guidance
is intended to decrease the risk of
adverse events, sometimes leading to
hospital admissions or reduced
treatment efficacy.
DATES: Submit either electronic or
written comments on the draft guidance
by September 28, 2022 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
[FR Doc. 2022–18527 Filed 8–26–22; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1527]
M12 Drug Interaction Studies;
International Council for
Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Electronic Submissions
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘M12
Drug Interaction Studies.’’ The draft
guidance was prepared under the
auspices of the International Council for
Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The draft guidance
provides general recommendations on
how to evaluate the pharmacokinetic
drug interaction potential mediated via
enzyme and transporter for
investigational drugs. The draft
guidance harmonizes the regional
requirements on in vitro and clinical
evaluation of drug-drug interactions for
a more consistent approach in design,
conduct, and interpretation of enzyme
and transporter-mediated interaction
during the development of an
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SUMMARY:
VerDate Sep<11>2014
17:01 Aug 26, 2022
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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
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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–
2022–D–1527 for ‘‘M12 Drug Interaction
Studies.’’ 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
E:\FR\FM\29AUN1.SGM
29AUN1
EN29AU22.009</GPH>
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52790-52801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0335]
Authorization of Emergency Use of a Biological Product During the
COVID-19 Pandemic; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use
during the COVID-19 pandemic. FDA has issued one Authorization for a
biological product as requested by Novavax, Inc. The Authorization
contains, among other things, conditions on the emergency use of the
authorized product. The Authorization follows the February 4, 2020,
determination by the Secretary of Health and Human Services (HHS) that
there is a public health emergency that has a significant potential to
affect national security or the health and security of U.S. citizens
living abroad and that involves a novel (new) coronavirus. The virus,
now named SARS-CoV-2, causes the illness COVID-19. On the basis of such
determination, the Secretary of HHS declared on March 27, 2020, that
circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic, pursuant to
the FD&C Act, subject to the terms of any authorization issued under
that section. The Authorization, which includes an explanation of the
reasons for issuance, is reprinted in this document.
DATES: The Authorization is effective as of July 13, 2022.
ADDRESSES: Submit written requests for a single copy of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives (among other criteria).
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological,
[[Page 52791]]
or nuclear agent or agents; (2) a determination by the Secretary of
Defense that there is a military emergency, or a significant potential
for a military emergency, involving a heightened risk to U.S. military
forces, including personnel operating under the authority of title 10
or title 50, U.S. Code, of attack with (A) a biological, chemical,
radiological, or nuclear agent or agents; or (B) an agent or agents
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces; \1\ (3) a
determination by the Secretary of HHS that there is a public health
emergency, or a significant potential for a public health emergency,
that affects, or has a significant potential to affect, national
security or the health and security of U.S. citizens living abroad, and
that involves a biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be attributable to such
agent or agents; or (4) the identification of a material threat by the
Secretary of Homeland Security pursuant to section 319F-2 of the Public
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect
national security or the health and security of U.S. citizens living
abroad.
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\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in an actual or potential emergency when the
Secretary of HHS has declared that circumstances exist justifying the
authorization of emergency use. Products appropriate for emergency use
may include products and uses that are not approved, cleared, or
licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21
U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42
U.S.C. 262), or conditionally approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after
consultation with the HHS Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health, and the
Director of the Centers for Disease Control and Prevention (to the
extent feasible and appropriate given the applicable circumstances),
FDA \2\ concludes: (1) that an agent referred to in a declaration of
emergency or threat can cause a serious or life-threatening disease or
condition; (2) that, based on the totality of scientific evidence
available to FDA, including data from adequate and well-controlled
clinical trials, if available, it is reasonable to believe that: (A)
the product may be effective in diagnosing, treating, or preventing (i)
such disease or condition; or (ii) a serious or life-threatening
disease or condition caused by a product authorized under section 564,
approved or cleared under the FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and (B) the known and potential
benefits of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of the
product, taking into consideration the material threat posed by the
agent or agents identified in a declaration under section 564(b)(1)(D)
of the FD&C Act, if applicable; (3) that there is no adequate,
approved, and available alternative to the product for diagnosing,
preventing, or treating such disease or condition; (4) in the case of a
determination described in section 564(b)(1)(B)(ii) of the FD&C Act,
that the request for emergency use is made by the Secretary of Defense;
and (5) that such other criteria as may be prescribed by regulation are
satisfied.
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\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.
III. The Authorization
The Authorization follows the February 4, 2020, determination by
the Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-
19. Notice of the Secretary's determination was provided in the Federal
Register on February 7, 2020 (85 FR 7316). On the basis of such
determination, the Secretary of HHS declared on March 27, 2020, that
circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic, pursuant to
section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section. Notice of the Secretary's declaration was
provided in the Federal Register on April 1, 2020 (85 FR 18250). Having
concluded that the criteria for issuance of the Authorization under
section 564(c) of the FD&C Act are met, FDA has issued the
authorization for the emergency use of a biological product during the
COVID-19 pandemic. On July 13, 2022, FDA issued an EUA to Novavax, Inc.
for the biological product Novavax COVID-19 Vaccine, Adjuvanted,
subject to the terms of the Authorization. The initial Authorization,
which is included below in its entirety after section IV of this
document (not including the authorized versions of the fact sheets and
other written materials), provides an explanation of the reasons for
issuance, as required by section 564(h)(1) of the FD&C Act. Any
subsequent reissuance of the Authorization can be found on FDA's web
page at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
IV. Electronic Access
An electronic version of this document and the full text of the
Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18527 Filed 8-26-22; 8:45 am]
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