Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability, 28608-28627 [2021-11234]
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
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Administrative Procedure Act (APA; 5
U.S.C. 551 et seq.) and FDA’s
regulations on good guidance practices
(§ 10.115 (21 CFR 10.115)). Under the
APA, FDA may use guidance documents
to ‘‘advise the public prospectively of
the manner in which the agency
proposes to exercise a discretionary
power.’’ 5 Accordingly, FDA’s good
guidance practice regulations define
‘‘guidance documents’’ to include
‘‘documents that relate to . . .
enforcement policies.’’ (§ 10.115(b)(2)).
Additionally, the HHS Notice is
supported by flawed facts. It cites, for
the proposition that the UDI and CPG
440.100 guidance resulted in price
increases for certain new drugs, only a
single observational study of 26
products, which included pricing
estimates that were not inflationadjusted over the 4-year observational
period, which could lead to an
overestimation of real price changes.6
The HHS Notice also erroneously ties
the 2015 price increase for the drug
DARAPRIM to the UDI. DARAPRIM was
approved as a new drug under the FD&C
Act in 1953. Following the 1962 FD&C
Act amendments, which required drugs
to demonstrate not only safety but
efficacy, DARAPRIM was found to be
effective, in 1971, as part of FDA’s
review of all new drugs that had been
approved only for safety before 1962.
DARAPRIM was then fully approved by
FDA as a safe and effective drug. For
years after its approval, DARAPRIM was
an off-patent, off-exclusivity drug
eligible for generic competition, but no
drug manufacturer sought and obtained
approval of a generic version during this
period. It was during this period, in
2015, that the holder of the approved
application for DARAPRIM significantly
raised the price of the drug. FDA
recently approved a generic version of
this product on February 28, 2020.7
Due to the HHS Notice’s legal and
factual inaccuracies, including those
described above, HHS and FDA believe
5 See the Attorney General’s Manual on the APA
(1947), at 30 n.3.
6 See R. Gupta et al., ‘‘The FDA Unapproved
Drugs Initiative: An Observational Study of the
Consequences for Drug Prices and Shortages in the
United States,’’ 23 Journal of Managed Care &
Specialty Pharmacy 1066 (October 2017) (the Yale
Study). Of note, the authors of the Yale Study
suggested ways to mitigate unintended
consequences of the UDI that did not include
terminating the UDI by withdrawing CPG 440.100
guidance or reinterpreting the definition of ‘‘new
drug.’’
7 FDA continues to maintain efforts to improve
the efficiency of the generic drug development,
review, and approval process, generally, and it
prioritizes the review of submissions for generic
drugs for which there are fewer than three approved
generic versions for the reference listed drug (RLD)
and for which there are no blocking patents or
exclusivities on the RLD.
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it is appropriate to withdraw the HHS
Notice at this time. The HHS Notice
does not accurately reflect the
Department’s or FDA’s thinking because
it is inconsistent with the FD&C Act,
FDA regulations, and judicial precedent,
among other legal authorities, and is not
supported by the facts. In addition, the
HHS Notice could result in significant
harm to public health by suggesting that
unsafe or ineffective drugs could
circumvent the drug approval process.
Although the withdrawal of FDA’s
CPG 440.100 guidance does not change
the legal obligations that apply to new
drugs, or FDA’s existing enforcement
authority over unapproved new drugs,
we recognize that the withdrawal of the
CPG may have created confusion for the
public, including regulated industry, as
to how FDA intends to prioritize its
enforcement resources in this area. FDA
therefore plans to issue guidance on this
topic consistent with good guidance
practices. The guidance will provide
appropriate updates regarding FDA’s
enforcement priorities for marketed
unapproved new drugs. In the interim,
before such guidance is issued, FDA
will continue to exercise its existing
general approach to prioritizing
regulatory and enforcement action,
which involves risk-based prioritization
in light of all the facts of a given
circumstance. Risk-based enforcement
best supports FDA’s public health
priorities.
FDA’s longstanding interpretation of
the statutory terms ‘‘new drug,’’
‘‘grandfathered,’’ and ‘‘GRASE’’ are
unchanged and the HHS Notice did not
affect the requirements that apply to
new drugs under the statutes FDA
administers. The HHS Notice did not,
and legally could not, provide a new
pathway for the legal marketing of
unapproved new drugs. Neither HHS
nor FDA has the authority to exempt a
product or class of products that are
new drugs under the FD&C Act from the
new drug approval requirements of the
FD&C Act. See Cutler v. Kennedy, 475
F. Supp. 838, 856 (D.D.C. 1979);
Hoffman-LaRoche v. Weinberger, 425 F.
Supp. 890, 892–894 (D.D.C. 1975).
Dated: May 17, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
Dated: May 20, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–11257 Filed 5–26–21; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0335]
Authorizations of Emergency Use of
Certain Biological Products 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 two Emergency Use
Authorizations (EUAs) (the
Authorizations) under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) for
biological products for use during the
COVID–19 pandemic. FDA has issued
one Authorization for biological
products as requested by Eli Lilly and
Company and one Authorization for a
biological product as requested by
Janssen Biotech, Inc. The
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorizations follow 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 Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES: The Authorization for Eli Lilly
and Company is effective as of February
9, 2021, and the Authorization for
Janssen Biotech, Inc. is effective as of
February 27, 2021.
ADDRESSES: Submit written requests for
single copies of the EUAs 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 Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
SUMMARY:
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
section for electronic access to the
Authorizations.
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:
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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.
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,
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
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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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
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
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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28609
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), 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.
III. The Authorizations
The Authorizations follow 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
Authorizations under section 564(c) of
the FD&C Act are met, FDA has issued
two authorizations for the emergency
use of biological products during the
COVID–19 pandemic. On February 9,
2021, FDA issued an EUA to Eli Lilly
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
and Company for bamlanivimab and
etesevimab, administered together,
subject to the terms of the
Authorization. On February 27, 2021,
FDA issued an EUA to Janssen Biotech,
Inc. for the Janssen COVID–19 Vaccine,
subject to the terms of the
Authorization. The initial
Authorizations, which are included
below in their entirety after section IV
of this document (not including the
authorized versions of the fact sheets
and other written materials), provide an
explanation of the reasons for issuance,
as required by section 564(h)(1) of the
FD&C Act. Any subsequent reissuances
of these Authorizations can be found on
FDA’s web page: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorizations and are available on the
internet at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
BILLING CODE 4164–01–P
U.S. FOOD & DRUG
IIDMINlSTUffON
February 9, 2021
Eli Lilly artdCompany
Attention: Christine Phillips, .PhD, RAC
Advisor Global Regulatory Affairs • US
Lilly Corporate Center
.Drop Code 2543
Indianapolis, IN 46285
RE:·
Emergency Use Authorization 094
Dear Ms. Phillips:
This letter is in response to .Eli Lilly and Company's e'Lilly") request that the.Food and Drug
Adrninistration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of
batnlanivimab and etesevimabadrninistered together.for the treatment of mild to moderate
coronavirus disease 2019 (COVID-19), as described irt the Scope of Authorization (Section II) of
this letter, pursuant to Section .564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21
u_.s.c. §360bbb-3).
On February 4, 2020, pursuant to Section 564(b)(l)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health
emergency that has.a significant potential to affect national security or the health and security of
United States citizens living abroad, and that involves the virus that causes COVID-19. 1 On .the
basis of such determination, the Secretary of HHS on March 27, 2020, declared that
circumstances existjustifying the authorization of emergency use of drugs and biological
products during the COVID-19 pandemic, pursuant to Section 564 of the .Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb~3), subject to terms of any authorization issued
urtder that section. z
Bamlanivimab and etesevimab are neutralizing IgG 1 monoclonal antibodies that bind to distinct
but overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV.2. They are both investigational drugs and are not currently approved for. any indication.
Basedon:thereview of the data from the.Phase 2/3 BLAZE-I trial (NC::T04427501), an ongoing
randomized, double-blind, placebo-controlled clini_cal trial, and the Phase 2 BLAZE-4 trial
(NCT04634409), an ongoing randomized, double-blind, placebo-controlled clinical trial, it is
reasonable to believe that batnlanivimab and etesevimab administered together maybe effective
U.S. DepartrnentofHealth and Human Services; Determination qfa Public HealthEmergencycmd Declaration
(April 1, 2020).
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1
that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) ofthe Federal Food, Drug, and
Cosmetic Act, 21 US. C. § 360bbb-3. February 4, 2020.
2 US. Department dfHealth and Human Services, Declaration that Circumstillices Exist Justifying Authorizaiions
Pursuant to Section 564(b) ofthe Federal Food, Drug, cmd Cosmetic Ac4 21 U.S. C. § 360bbb~3; 85 FR 18250
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28611
Page 2 --- Eli Lilly and Company
for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age
and older weighingat least 40 kg)with positive results of direct SARS-CoV-'2 viral testing,. and
who ate -at high risk for progressing to severe COVrD-19 and/ot hospitalization,,. and that, when
used under the conditions described in this authorization, the known and potential benefits of
bamlanivimab and etesevimab administered together outweigh the known lUld potential risks of
such products.
Having concluded that the criteria for issuance of this authorization under Section_ 564(c) of the
Act are met; I am authorizing the emergency use ofban1lanivimab for treatment of COVID-19,
as described in the Scope of Authorization section ofthis letter (Section II) and subject to the
terms ofthis authorization.
l.
Criteria fl)r l!i$uance of ;\;uthorizatfon
I have concluded that the emergency use of bamlanivimab and etesevimab for the treatment of
COVID-19 when administered as described in the Scope of Authorization (Section II) meets the
criteria for issuance of m authorization under Section 564(c) of the Act, because:
1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including
severe respiratory ilmess,.to humans infected by this virus;
2. Based on the totalityofscientific evidence available to FDA, itis reasonable to belteve
that bamlanivimab arid etesevimab administered together may be effective in treating
mild to moderate COVID-19 in adults and pediatric patients (12 years ofage and older
weighing at least 40 kg) with positive results ofdfrect SARS,CoV-2 viral testing, and
who are at high risk for progressing to severe COVID-f9 and/or hospitalization, and
that, when administered as described in the Scope of Authorization (Section II) and
used under the conditions described in this authorization, the known and potential
benefits ofban1lanivimab and etesevimab outweigh the known and potential risks of
such product; and
3. There is no adequate, approved, and available alternative to the emergency use of
ban:ilatlivinuib and etesevimab as described in the Scope of Authorization (Section II)
for the treatment of mild to moderate COVID-19 in adults and pediatric patients ( 12
years of.age and older weighing at least 40.kg) with positive results of direct SARS•
Co V-2 viral testing, and who are at high risk for progressing to severe COVID-19
·
and/or hospitalization. 3
n;
Si'.op~ ot'Authorization
I have concluded, pursuant to Section 564(dXl) of the Act, thatthe scope of this authorization is
limited as follows:
•
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No other criteria of issuance have be.en prescribed by regulation under Section 564(c)(4) of the Acl
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3
Distribution of the authorized bamlanivimab and etesevimab will be controlted by the
United Sfatei; (U.S.) Government for use consistent with the terms and conditions of
28612
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
Page 3 -- Eli Lilly and Company
this EUA. Lilly will supply bamlanivimab and etesevi:mab to authorized distributors4,
who will distribute to healthcare facilities or healthcare providers as directed by the
U.S. Government, in collaboration with state and local government authorities as
needed;
•
The bamlanivi:mab and etesevimab covered by this authorization will be administered
together only by healthcare providers to treat mild to moderate COVID-19 in adults
and pediatric patients ( 12 years of age and older weighing at least 40 kg) with positive
results of direct SARS-Co V-2 viral testing, and who are at high risk for progressing
to severe COVID-19 and/or hospitalization;
•
Etesevimab may only be administered together with bamlanivimab5;
•
Bamlanivimab and etesevimab are not authorized for use in the following patient
populations 6 :
•
•
Adults or pediatric patients who are hospitalized due to COVID-19, or
Adults or pediatric patients who require oxygen therapy due to COVID19, or
Adults or pediatric patients who require an increase in baseline oxygen
flow rate due to COVID-19 in those patients on chronic oxygen therapy
due to underlying non-COVID-19-related comorbidity.
•
•
Bamlanivimab and e_tesevimab may only be administered together in settings in
which health care providers have immediate access to medications to treat a severe
infusion reaction, such as anaphylaxis, and the ability to activate the emergency
medical system (EMS), as necessary.
•
TI1e use ofbamlanivimab and etesevimab covered_ by this authorization.must be in
accordance with the dosing regimens as detailed in the authorized Fact Sheets.
Product Description
Bamlanivimab and ctesevimab are rteutralizing lgGl monoclonal antibodies that bind to distinct
but overlapping epitopes within the receptor bindirtg domain of the spike protein of SARS-Co V"Authorized Distributor(s)" are identified by Lilly as an entity or entities allowed to distribute authorized
bamlanivimab.
5.At the time of the issuance of this EDA, bamlanivimab, a monoclonal antibody therapy, is authorized under a
separate EUA as a monotherapy for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12
years of age and older weighing at least 40 kg) with positive. results of direct SARS-Co V-2 viral testing, and who are
at high risk for progressing to severe COVID-19 and/or hospitalization. (For a listing of FDA EUAs, see FDA's
website at: Emergency Use Aythorization I FDA). Etesevimab, alone, has not been evaluated as a treatment for
patients with COVID-19. Etesevimab may only be administered together with bamlanivimab consistent with the
terms and conditions of this authorization.
6 Treatment with bamlanivim_ab and etesevimab has not been studied in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as bamlaniviniab and etesevimi,b, may be associated with worse clinical outcomes
when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
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4
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28613
Page 4 -Eli Lilly and Company
2. Bamlanivimab.injection,700 mg/20 mL, and etesevimab, 700.mg/20 mL, are sterile,
preservati:ve0 free deatto opalescentartdcolotless to. slightlyyefiowto•slightly brown solutions
to be diluted prior to itifusiM. One vial ofbarnlanivitnab (20 mL) and two vials of etesevimab
(40111L) are to be added tQ a pt:efilled0i?%sodium chloride µifusion bag i1S descriQ¢diir~
he!llthcaf(! provider fa,ct ~heet. The authorized batnU\tlivimab µ1cludes a viallabelillldlor ca.rto11
labeling that is clearly marked ~•For
under EmergencyUse Authorization (EUA)"'..111e
authorized etesevimab includes a vialJabel and/or carton labeling. that is .clearly marked "For U$C
under Emergency Ose Authorization(EUA)"ancl "MOS:t A.PM!NlStER WITH
BAMLANIVIMAR"
use
Banilanivimab,injection, 70()mg120 ml,, and etesevhna1'; injecfion,700mg/20 mt via,}sshould
be stotecl.inunopened• vialsunderrefrigetatedtemperatureat2°C to 8°0 (36°F·to 46"F):inthe
original c~o11toprotect:from.lighttµ1tllti111e ofttse; IJifote4 t>iM1anivimab arid iltesevimat,
iilfusionsoluti()n
be $10tedfQr up to24 hoUt$ lit reffig~ratedteinperatttr,e{2"Cto 8°<;(3~°F
to 46?Fl)and up to 7hours at room temperature (20°C to>25°C [6&°F to 77tiF]) including
infusion time.
can
Bltfulan1vhnahand eteseVimab are irt,lthorizediot emer~ericy ttse aS desctibedfathe Sc()f)e of
A;.uthorization.(Section II)witbtbef<>l1QWJ1:1~ producl-speciflc mfot111at:iQ1:1 requirell to 1'e made
available to healthcare providers and patietits, parents.and caregivers,respectively, through
Lilly's website atw;ww,BAM@dETE;c:om:
•
geaith
Fact stieet tor
Care Providers: Emergency tJse•Authorizatioh (EU..\:) of
Bamlanivunab and 'Etesevimab
• Fact Sheet tot:" PatierttS; l>arents 1:tnd Caregivers: Emergencyt:fse Authorizaii<>n:(EUA,) of
:&i:rrililllivimab and EtesevimabforCoi::on.avirus Disease 2019(COVID-l9-)
fhave conduded, putsuatiUo Section 564(d)(2}ofthe Act, that it is reasonabletobeHeve that
the kno:Wn and potential benefits ofblMlanivimab and etesevimab w1ien:used for the treatment
of COVID•l !> and.used in accordance with this S.cope ofAuthorization (SectionII); outweigh
its known and potential risks.
I have conch.uied, pttrsu.mtto Secti&i 564(d)(3Jofth~ Act, based 011the totality ofscientillc
evidence ayailab,le to FPA. thlU it js r:eaS<mal:>leto believe th1;it ~anivimab and etesevimab may
be effectlye for the 1reat.ruent of COVID-19 when used in accordance with this Scope of
Authorization (Section II), pursuantto Section 564(c)(2)(AJofthe Act.
Havirigreviewed the scientific infonnation avaifabfo to FDA, including.the ihfotmattori
suppqrtihg the conclusions described in Section I.above, I have co11cluile(l that bamlanivimab and
etesevimab (as 4escnbed in thisScope of Authorization (SectionII))meet~ criteria set forth in
Section 564{c) ofthe Act concerning safety and potential effectiveness.
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The emergency use of your product tmderan EDA must be c011sistent with, mid may notexceed, the
temis ofthe AuthOrization, including.the Scope ofAuthoriziltion($e.:;tion II):and the Conditions <>f
Authorization (Section III): Subject to the terms ofthisE'tJA and under the circumstances set forth in
28614
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
Page 5 -- Eli Lilly and Company
the Secretary ofHHS's determination under Section 564(bXl)(C) described above and theSecretary
of HHS's corre$ponding dedaration under Section 564(bX1); bamlanivimab and etesevirtiab
administered together are authorized to treat mild to moderate COVID-19illness in adttfts and
pediatric patients (12 yeats-0f age and older weighing at least 40 kg) with positive results of direct
SAR.S-CoV-2 viral testing, and who are at high rislc fur progressing to severe COV!D-19 illness
and/or hospitalization as described in the Scope of Authorization (Section II) under this EUA,
despite the fact that it does not meet certain requirements otherwise required by applicable federal
law.
IlL
Conditions ofAuthorization
l'iirsuant to Section 564. ofthe Act, I a111 establishing the following conditions on this authorization:
Eli Lilly and Company (Lilly) and Authorized Distributors
A Lilly and authorized distributor(s) will ensure that the authorized bamlariivimab. and
etesevirnabare distributed, as directed by the U.S. government, and the authorized labeling
(i.e., Fact Sheets) will be made available to healthcare facilities and/or healthcare providers
consistent with the tenns of this letter.
R Lilly·and authorized distributoi(s) will ensure that appropriate storage and cold chain is·
maintained until the product is delivered to healthcare facilities and/or healthcare providers.
C, Lilly and authorized distributot(s) will ensure that the terniS ofthis EDA are made available
to all relevant stakeholders (e.g.., U.S. government agencies, state and local government
authorities; authorized distributors, healthcare facilities, healthcare providers) involved in
distributing or receiving authorized bamlarlivimab and etesevimab, Lilly will provide to all
.relevant stakeholders a copy of thisletter of authorization and c-0mmunicate any
subsequent amendments that might be made to this letter ofauthorization and its authorized
accompanying materials (i.e,, Fact Sheets).
D. Lilly may requestchang.:;s to this authorization, including to the authorized Fact Sheets for
banilanivimab and etesevitnab. Any request for changes to this EUA must be submitted to
the Office of Infectious Diseases/Office ofNewDrugs!Center for Drug Evaluation and
Research. Such changes require appropriate authorizatfon prior to implementa:tion.7
The following types of revisions may be authorized ,vithotit reili$uing thisletter: (1) changes to the authorized
labeling; (2) non~substantive editorial corrections to this letter; (3) new types of authorized labeling, including riew
fact sheets; (4)new carton/oontainer Iabels;.(5) expiration dating ex,tensions; (6) changes.to manufacturing
processes, including tests or other a\lthorized cortlponents ofmanufacturin:g; ('7) new conditions ofauthorization to
require data collection or study; (8) ne,v strengths of the authorized product, new product sources.(e: g., of active
pharmaceutical ingredient) or of product cOinporients. For changes to the authorization; including the authorize(\
labeling, of the type listed in.{3), (6); ('1), or (8), review andi;oncurrence isreqirired from the Counter-TerrOrisnI and
Emergency Coordination Staff/Offite of the Center Directot/CPERandthe Office ol'Countertetrorism and
Emerging Thteat;;lOffice of thci Chief Scientist,
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7
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28615
P;age 6-EliLillyan(lCompany
E. Lillymaydevelop:instructionalmd educational.materials to-facilitate the emergency use of
the-authorized bartilanivitnah and.etesevimab(e.~~· materlaispro\ddfug mformation on
productadministtatio1nlhd/ot paifertttnoriitotihg) undetc◊ttditioli O ofthiltE:t1A
:t'\ }Jllywill~QrtfuFl)A;~ MV~e eYimt anij~ltnedi~Qll-\'ll't~~at~witb:
'theuseofthe. authorized.bamlanivnnab andetesevnnab'thatare.reportedto.Lillyusing
eitb¢t:0fthe.£0Uowing options.
·@onh:Su't,mitr~risthrQugh'the•Saf'clyReportfug~(SRJ:i)as~descci~ontlui:mA
'SRP;WebJrage;
·
··
·
·
·
Option 2; Subintt tepQrts:difectly through the· Electronic: Sufuirissioris Gateway {ESO) :as
:tie$(:!.'11:)¢if<>li'thefcQ11$ el~#.t9nktsu11tfiissiew··webp~.
Submitted reports :under bo'th•options.should state: ''bamlanivunalrnnd etesevnnalruse for
,CQVID-19 under .Etnet~ey use Authorization• (EUA.);" For reports submitted un.der
option 1, include th$1an~.at the begttlliirtg ofthe qti¢$tlon "l)escribe_Evenr'futfutthet
an~, EotteJ!Qt:ts.~µl)mitted undiitt Option 2, inclu<f.e'~ huigµageatthe 't>egttlliirtg ofthe
~e NaJ'.fl#i:ve'' :tiel~
·
·
'<l . Afimiiliutiicturlrigt'actHtieswilloompiywi.th.Uiiterit.Good.Manufiictutiiig.Priictice
te~®t!!-
It
LillywillI¢tainan itldependenttliiriJJ)lllty(Le;,nqf affiliatajwnb tilly)tg conduct a
re\dew of the batch records and any underlyingdata·and associated discrepancies of
bamlanivimab drug substance n:1an:tlfactl.ited at Lilly Branchburg, Nl
• F<>tajl batches manur~dprionothe ei'fecti\'¢ da1:e. of lliis a\lthoriiatlm1. these
ba¢hes cm 't>ereltiaseitwhilere\iiew is: ongoing.
·
• For all batche$ tn:llhutactuted after the effective date oftln§ amhQt1Zatim1.thetrutd
parfyre\d~·•CM. be petfottn()dconcµrreni'toLlUy's l?afuhrel.:ase process,
Iffue independentre\dewf"'mds, priorfurelease;;a. discrepancy with significa:rif potentialto
affect criticalquality atttt'butes, theprodUct mustrtot be relea$ed unless and until the issue
is satisfactorjly te!lOlv¢,.Apyi.li$ctepanciesJOU1'1tlby #le mdependentre\dew, whether
prfod.o-0r:iuterrel~ase;.mll$f be rep()rted to the Agency ina summary report; submitted
eve1yl4.calendardays, andinellideLilly'scorrecti:veandpreventiveactionplansfoteach
dis¢tepancy,irtcluding wlrethermatket:actiort istequired..Theplans itlustincludem
appro¢:iate evaluation ofeachcliSbrepancy's poiemi:al impact on. any released drug
.
:/lUbst;ince a,nd ll$$()Cial¢ lirug product.
L Lilly will retain an independenl'third~parfy(Le,, notafftliafed with LiHy}fo.conduct
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labofatotyrelease iestin:g.ofbamlani\iimab··drug.subs'tancemanuf~ at·Lilly,
Btartchbtitg(excluding•bi<>butden and ¢ndot()xintesting). Any disctepandiesfound by the
indepertdent la!,otiltoty mll$f be reportecl to theAgency in a.sUilllillll)' .report, submitted
everyl4.cale11ffilr ~ys, ~ includeLilly'scqrrectiveand prevetiiive.a,cli'Qnplansfor each
28616
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
I>.age 7 -Eli Lilly and.ComJ>311y
discrepancy-. Theplans·mustinclude an appropriate evaluation ofeach discrepancy~s
potential:itnpacton.anyreleased drug substance and$sociated. drug product.
J, LlllyWillsu1;n;iitmfQftll/ltionfotl,'te~9Y witlli_nthr®work:ing(lllyso.f~ceipt().fany
·infonnllii.911 con~g 1111ybatcl1 of:~ani.:vlma\, oret~eyimab (wl:i.ethertlie t,ai:cl1is
.distributed oruot); as. follows: (1 )information concerning anyincidenUhat.causesthe
product or itsl;ibeling:to be nus.tllkenfor.. orappliedtQ, another.article~ and O)information
•concet®Iganywcrobi9k,gicalqontamifiatip11,orailysignificantchemicatphysic:lil.◊r
other change it:! debmo.rll'tioo in the product; or anyfailure of:oue orm:o.re batches. of:the
productfomeeftheestablishedspecifications, LiUywill include initsnotificalionfo the
~cy whether the batch, or:batches; in question will.be recalled.. If:FDArequests that
lh:ese,.or anyo-ihetbatches/atany time, be:recalled, Lillynntstrecall thetrt.
K Li.1lyWillnolimp1ementanychanges t()the dei;cripti׵ o.f:the proou~ 01anllfacturing
:process, facilities and equipment; and elemerits of the associated confrolsirategy that: assure
process performance and qualit)1-0f:the authori.zed.pf()ductwithoutnotificatioh :to and
.corictttterice hytheAgency asdescribedUridercon.ditforti);
J,. Lilly .will 1111ll11lfacture 1tt1d ~st t,llU11ani.viU1a\, 1111d ete§eyfuia\, per tile process 1tt1d I11et11Qds.,
includiti:gin~process samplit:igand testing and fiirishingproducttesting(release and.
st;ibility)to meet all sPeCifications as detailed.in Lilly's EUAreqµest. ·
M. ·Llny will indi\iidual.ly·rrst bamtaniyim:ab.and eteseyiin:ahwiihaumque product NOC under
tlienrm:ketit:igcatego.zyofUm1pprovaj Dnlg•Other,.Further; eaphli~gWill.includeeaph
establisbment.where manUfacturingis petfonnedforthe.drug and.the type ofoperation
penormed at each suchestablishment:
ft
Through a process ofinyentocy ~I.Lilly andlllithorizeddistributor(s)Will01aintain
records regarding distribution ofthe authorized bamlanivimab and etesevurnib(i.e,;-fot
numbers, quantity; receiving site, receipt date).
tt titly and authorlzedtiistril!utQt:(s)willrnilbavaifableto FOl\upo11 req11estany~<;otd$
1)111lllfa,inell in 90@@011 with:thi.s l1lUA
·
.Heiiltlicare Facilities to Wb6riithe Aiithhriied Biiliiliirii~ah and Etese\iimah.Afu Distributed and
Healthcare ProvidetsAdnilitlsteringthe AuthorizedBan;tllln,iyjmab and Etesevitnab
l', 'f.I¢lllthcarefapilities 1111d})ealthcare provj:ders will ens,uretliatthey are aware oftlie1etter Qf
·auihorization;•. and.the·termsnerein;.·and thattheatithorized·.FactSheetsaremade available
to.bealthcareproviders.and.to.·palients.and.caregivers;.respectively,.through appropriate
melili.$, ptlorto ~ o n tlfbarnlaniVimab and eteseY.iniabim deseribedit:!Jhe Scope
-0f'Authorization(Sectiot1 ll) Mder·this EUA..
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Q; Healthcarefacilities and healthcare providers recefvingbamlaniviinab:and. etesevimab will
trackserioUs adv~eeVeri.ts that are considetedto be potentially attributable to the use of
.bamlanivimaban:d etesevimahun®thl$ authorizalionandmustreportthese to FOA in
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28617
Page 8 -EliLillrandC()mpany
•accordance:withthe.Fact.SheetforHealthcareProviders.Complete and.submita
MedWatch fortfi (www~tda.gqv/#iedwatchlt@ortJitfi\), orO>itlplete Md submit FDA
·Fortfi~SOO(hiWth.pr:ofessional}hyfax(l-'8QO.,FDA-Ot78}Cthesefonnscanbe fol.ffidvia
:Jirll(,·~t:>o-ve), ··()ajl 1~&00~PDA-l0'.Uf◊rqµesgot1S, $µbfilitt~d~1't$;$119µld $iaW;
•~~amt~:vimat,~d eftlse:vifilal:,•.lll!efQt(;O.WQ- 19:w:l4er ~~en1;:yQse.!\.µth9rizllit"Oµ
{EtJA.)"atdhe· begirmingofthequestion.''Describe Event?forfurlher·analysis,
It
Heii.ltln:arefi©lities an:dheattht!ate ptil\iidet:$ will ensure:mat~!lte$1:~e~t1oo14
·ch/ufi.ismainfaine4tlhfilthep~ are,aclnliitiSf.el'.ed.(!()nsi$nt·witlitheuinnsofthis
letter.
.
s, through.a process o:t'irivemmy:corttrol.healthcarefa8lltles wlli mamtahirecords regartling
thec:lis~ autl:t<)rizedb1unJ.an:fvintab;u1d ete$evinrab (i.e., l9t.i:mmbet:$.quan:tity,
r¢ceivingsite,receil)tdate). pt'Qductsto~;•and1:1taintaippatientinfortnaiion(e,g.,pllfient
name, age~disease manifestatiofl\ number ofdoses administered per patient, other drugs
adtninisteted).
't. •1:Iea:lthc~facilities willens:1irethatan:yr:ee<>t9$associated with thisEUA are maintained
untilt1l>tified by LiUyari~or:fDA-,.$uchrecord$ \Vill.~ tlladell,yall:al:,ktQ Li]Jy;Iffl.$~an:d
FDA·forinspectionuponrequest
t1. ·Heal:tlmarefacilitiei.•an:dptovidetsWilltep()tfth~.in:t'~on llhd:titilization&tta
as dire:ciedbythe.U.S. Peparlmeftt <lfllealth andltum:anServices:.
Conditions RelatedtoPrinted Matter.Advertising and Promotion
Y. All descriptive pritrted matter, as well as: advertising llhdprotnotionru filiitenal, tefatin~ to
theuse•ofthebamlanivimabcandeiesevimab underthfoauthorizatiooshall·beoonsistem
·withtheauthorizedlabelmg; as well as the tennssetforth in this EUAand the applicable
requirements setforthJnthe Act and.FDA regulations.
W. N◊deScriptive:plintedmatlet; as weU as.~:verlisin~ Qr ptofilotion;utnaierial, r¢l:µmgto the
11$(; ofban:tli111ivimi$ ancl et¢se:vifilab un4ertlii~ auth.<)tizatiott: may 1'¢J>Nsentorsµ~•that
$Uchproductsare·.·safeor effective··when.usedfor thetreatinentofmild to.moderate
COVJD..19:.inadtilts andpediatricpatients .(Uyeatsofage llhdoldetweighlngadeast40
kg) with positive res~<lftlitect:S:AR$,.cov~2
testmg. llhd.who are athighrisk.fot
progressing to sever¢ C:OVIO-l9and/Qr hogpifulization: · ·
·
vital
X Alldescriptive printed matter; as.well as advertising and promotional material,relatingto
·t11euseofth¢bamlanivmiaband.etesevimab underthis.aufhorization,clearly·llhd
(!()ttspicuo1i$ly shallstate thl¢:
•
·
Bamfa:ni~ and etese\iimab have noth¢en appro:ved, but have been
autl:torizedfQr•emergency·qse·t,y fDAtol>e~~edtogetlier·forthe·
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treatment ofmildtomoderate COVID-.19in adults and•pediafric patients (12
years:ofage andolderweighingatleli$1:40k:g) with.positive resultsofdirect
28618
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
P:age 9 - EliLillrandCompany
SARS,CoV-2 viraltesting,.and who are at high riskfor progressingto severe
COVID-19 and/or hospitafizatioo.
• Ba1iliaruvnnab'and eteseviniab are iffitltorizedto be administered togetherfor
the tr:eatmenfot)nildtl> moderllte COVID-1? in ad'cilts lUld pediatric patients
(12 yeru:sl>fage /11'.!.d ()Ider weighing at l~ast 40kg) with positive res'cilts of
direct SARS-CoV~2 viral testing,,andwhoare athighriskforprogressingto
severe covro~19 md/or hospitalizationorilyfor the duration ofthe declllratfon
that circumstartces existJustifying theiauthorizafion ofthe emergency use ofthe
bamlanivnnabunder :Section 564(b)(1}oftheAct,21 tT.S:C. § 3:60bbb-'.3(h)(l);
llllless the:: arithorizii.ti<?11is t~.ited ()f revoked sooner,
· ·· · ·
w;
Duratwn ofAuthoiitation
'This 11,tl'A will be effective :untilth~ de~latatlottthat cfrc:utn:stances ·existJ1:tstifyingthe
atiillorizati<>q of:the emerge}Jcy :use ofdrµ~ /11'.!.d bio.togical pro!,l:ucts <i:urfu.g the COV1P.l9
pandemic is terminated under:Section'564(b)(2)ofthe Act or the EU A.is revoked under Section
564(g) of'the Act.
Sincerely,
R:APM Penii;e NL HintQn
Chief Scientist
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Food,and•Drug.Athtiinistratiori
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28619
U•.S; FOOD &: DRUG
AtlMINISTR,M!QN
February 27, 2021
Janssen Biotech, Inc,
Attention: Ms.. Ruta W-alawalkar
920 Route 202
Raritan, NJ 08869
Dear Ms. Walawalkar:
This letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug
Administration (FDA).issue an Emergency Use Authorization (EUA) for emergency use of the
Jai1ssen COVID-19 Vaccine for the prevention of Corona.virus Disease 2019 (COVID-19)for
individuals 18 years of age and older, as described in the Scope of Authorization (Section II) of
this letter, pursuant to Section 564 of the Federal Food; Drug, and Cosmetic Act (the FD&C Act
or the Act) (21 u:s.c. 360bbb-3).
On Febmary 4, 2020, pursuant to Section 564(b)(l)(C)ofthe Act, the Secretary orthe
Department of Health and Human Services (HHS) determined that there is a public health
emergency that has a significant potential to affect national security or the health and security of
United States citizens living abroad, and that involves the virus that causes COVID-19. 1 On the
basis of such detennination, the Secretary of HHS on March 27, 2020, declare.d 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 Act, subject to tem1s of
any authorization issued under that section. 2
TI1e Janssen COVID-19 Vaccine is for active immunization to prevent COVID-19 caused by
severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age
and older. The vaccine contains a recombinant; replication-incompetent human adenovirus
serotype 26 (Ad26) vector, encoding the SARS-CoV-2 viral spike (S) glycoprotein, stabilized in
its pre-fusio11 fonn. It is an investigational vaccine not licensed for any indication.
FDA reviewed safety ai1d efficacy data from an ongoing phase 3 trial which has enrolled 43,783
participants randomized 1: 1 to receive Janssen COVID-19 Vaccine or saline control. The trial
has e11rolled participants 18 years of age and older. FDA's re.view has considered the safety and
effectiveness data as they relate to the request for emergency use authorization. FDA's review of
the available safety data from 43,783 participants 18 years ofage and older, who were followed
U.S. Department of Health and Human S~rvices, Determination ofa Public Hea.lth Emergency and Declaration
that Circunfstances Exist Justifying Authoritations Pursuant to Section 564(b} of the Federal Food, Drng, and
Cosmetic Act, 21 U.S.C § 360bbb-3. Febrimry 4, 2020.
1
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2 U:S. Department of Health and Human Services, Declaration fliat Circumstances Exist Justifying Authorizations
Pursuant to Section 564(b) of the Federal Food, Drng, and Cosmetic Act, 21 U.S.C. § 36/Jbbb-3, 85 FR 18250
(April 1, 2020).
28620
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
Page 2 - Janssen Biotech, Inc.
for a median duration of eightweeks after receiving the vaccine or placebo, did.notidentify
specific slifety concemstb:at would preclude issuance ofan EUA. FI>A's analysis ofthe efficacy
data ftoru. 39,321 participants i& years ofage: and older who-were SARS~CoV-2. serortegative or
-vllo had anJ;u:1known.serosta'tlls at paselin:1;1 showthittthe vaccin1;1 was:. 66.9% effective (95%
confidence interval (Cl): $9;0,e 73.4)and 66.1% effective. (95% CI: 55.0, 74. &)in preventing
moderate.to severe/critical COVID.J9 occurring at least 14 days and. at least 28 days after
vaccination, respectiwly. Based on these<datit, and review of manufacturing information
regarding product quality and co1tsistency,it is reasonable to believe thatth.i Janssen. COVID-19
VaccinemaYbe effective, Additionally, it is reasonal:ile,to cqnclude; bas~d on th~ totality ofthe
potential benefits of theJansseffCOVI~ 1.9
scientific ~vidence available, that the kn~wn
Vaccine outweigh its known and potential risks, for the prevention ofCOVID-19 in individuals
18 years ofageandoider. Finally, on February26,202f~ the VaccinesandRefatedBiological
J>roclucisAdviS()ry'Committee vQted in agreett1entwith this cQn¢Iusion.
and
Having conclucled that the criteriaIo.issuance ofthis authorization under Section564(c)ofthe
authorizing the emergencruse ofthe Janssen COVID-19 Vaccine forthe
Act are met.I
prevention ofCQVI0-19, as described in the $cope, of Authorization section ofthis letter
(Section II) and subject to thetefttiS ofthis authorization.
am
L
.Crifi!ri11 forlssilitn~ofAuthotiiation
fhave cqndudedthafthe ett1ergencyuse ofthe..Janssen COVI1>0 19 Vaccinetorthe pr¢venti<mof
COVID-t!Jwhen a4ministered ~ described in the $copeofAu.tho1,'i:iati()p.{$ection ll}meets the
criteriaforissuance ofanauthorization.under Section564(c).ofthe Act, because:
L $.ARS~CoV~2 c1trt c:a:use a serious or life-furootenil:).g disease or conditfo11,. including
severe respiratory illness.to humans infected bythisvirus;
2. Basedonthetotalityofscieritiffoevidence available t-OFDA, itis reasonable to believe
that the .Janssen Cd\UD~ 19 Vaccine may he effective i:n: preventing COVII).;19, and
that, when used under the c;onditions described intltis.iuthotizafion, the known and
potential benefits QftheJ1trtssenCOVIlJ~l9 Vaccine wllen ttsed t9 prevei.rt.<:OVID-19
outweigh.its. known and potential risks; and
3.
n.
There iKno adequatet a:pproved,and availa.hie alteri:iative to the emergencyuse o:fthe
Janssen GQVID-19 Vaccineto preven.tCOVID-19. 3.
scope 6f Auth6rliatioo
1have concluded, pursuantto Sedfon 564(dj(iJofthe A.ct; thattl1e0 scope of this authorization is
limited as follows:
VerDate Sep<11>2014
No other criteria ofissuance.have been prescribedhy:regulationunderSeclion564(c)(4)of the.Act
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3
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28621
Page 3 -Janssen Biotech, fuc.
•
•
•
Janssen Biotech, fuc. will.supply the Janssen COVID-19 Vaccine, either directly
or through authorized distributor(s)4 to emergency response stakeholders5 as
directed bythe U.S. government, including the Centers for Disease Controland
Prevention (CDC) and/or other designee, for use consistent with the terms and
conditions of this EUA;
The Jattssen COVID-19 Vaccine covered bythis authorization will be
administered by vaccination providers 6 and used only to prevent COVII).19 in
individuals ages 18 and older; Md
The Janssen COVID-19 Vaccine.may be administered by a vaccination provider
with()ut an individual prescription for each vaccine recipient.
Product De/lcription
TI1e Janssen COVID-19 Vaccine is supplied as a suspension in multi-dose vials: The Janssen
COVID-19 Vaccine does not contain a preservative.
Each 0.5 mL dose of the Janssen COVID-19 Vaccine is fommlatedto contai11 5xtoM virus
particles of the Ad26 vector:encodihg the S glycoprotein of SARS°CoV-2. Each dose of the
Janssen COVID-19 Vaccine also includes the following inactive ingredients 2.19 mg sodium
chloride, 0.14 mg citric acid monohydrate, 2.02 mgtrisodium citrate dihydrate, 0.16 mg
''Authorized Distributor(s)" are identified by JaiJSsenBfotech, Inc:or, if app!lcable, by a U}3. goven:unent entity,
such as the Centers. for Disease Control and Prevention (CDC).and/or other designee, as an entity or entities allowed
to distribute authorized JanssenCOVID-19 Vaccine.
4
s For purposes of this. letter, "emergency response stakeholder" refers to a public health agertcyartd its delegates that
have legal responsibilit,y and authority for responding to an incident, based on politicalor geographical boundary
lines (e.g., city, county, tribal territorial, State, or.Federal), or functional (e,g., law enfbrcemeritar public health
range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In sohle cases
(e:g., depending ona state qr Joe.al jurisdictiort's COVID-19 vaccination response organization antl plans), there
might be overlapping roles and responsibilities among "einergency response .stakeholders~ artd "vaccination
providers".(e,g.,.if a local health department is mlministering COVID-19 vatcines; ifa pharmacy is acting in ari
official capacity under the authority of the state health department.to administer CQVID-19 vaccines). Ih such cases,
it is expected that the .conditions of authorization that apply ro emergency .response stakeholders and vacciriation
providers will all be met
6 For
purposes of this letter, "vaccinationprovider''refersto the facility, organization, or healthcare provider
licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare
professionals, such as nurses and pharmacists pursuant to state law under a standing order issued. by the state health
officer) to minister or provide vaccination services in accordance with the. applicable emergencyTesponse
stak:eholder's official COV:rD-19 vaccination and emergency response plan(s) and who is enrolled in the CDC
COVID0 19 Vaccination Program. For purposes of this letter, "healthcare provider'' also refers to a person authorized
by the US. Deyiartment of Health and.Human Services (e.g:, under the PREP ActDeclarationfor Medical
Countermeasures against COVID-l 9}to administer FDA-authorized COVJDclSJ.vaccine (e,g., qualified.pharmacy
technicians and State-authorized pharmacy interns acting under the supervision of a qualifiedpharmacist). See, e.g.,
HHS. Fourth.Amendment t.o the Declaration Under the Public Readiness and Emergency Preparedness Actfer
Medical Countermeasures Against cOnD-HlandRepuhlicationofJhe Declaration, 85 FR 79190 QJecember9,
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2020).
28622
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
Eage 4 -Janssen Biotech, Inc.
polysorbate'-80; 25.. 5 mg 2:..hydroxypropyH3•cyc.lodei..1rin; 2,Q4 mg ethanoL Each dose may also
contain residual amounts of host cell proteins (:=:;0.15mcg} and/or host cell DNA (:s3 ng}.
The dosing regimen is a single doseofOS.niL
The manufacture ofthe authorized Janssen COVID--19 Vaccine is lU11ited tcrthoseJacili'ties
identified and agreed uponin Janssen's requesHor authorization.
TI1eJanssen.COVID-,19 Vaccine vial label and.carton labels are clearly markedfor "Emergency
Use Authorization.•? The Janssen COVID-19Vaccine is authorized to be distributed, stored,
further redistribute~ and ruiniinistered by emergency response stakeholders when packaged in
the authorized manufacturer packawng (Le~, viais and cartons), despite the f actthat the vial and
carton fabets maynotcontain infonnatl.6n that 6therwise W<mld be required ooder the. FD&C
Act.
The JanssenCOVI0:..19 Vaccine is auth6rized for emergency use with t:hefolloWfug pr6duct•
specific infonnation reqµired to ·be made ;i:vailable to vaccin;iti0!1 providers and recipients,
respectiyely(referredto as "anthorized labelint'):
•
FacfSheet for Healthcare :Providers Administering Vaccine (Vaccination Providers):
Emergency Use Authorization (EUA} ofthe Janssen COVID-19Vaccinefo Prevent
Cor<>rta-virus Disease 2019{CO:VID49)
•
Fact Sheet forRedpientsand ·Caregivers: Emergencyl.Jse Authorization (El.Ji\) of the
Jansr;enCOVII>~ 1.9 Vacci11e to PteyentCor.011avirus. Qisease 2019 (COVID~ 19)fo
!ndividiials lRYears ofAge and Older
fhaveconcluded. .pursuant to Section 564(d)(2}oftheAc¾ that itis reasonable to believe.that
the known and potential benefits ofthe Janssen·CQVIO:.. 19Vae<.;ine,when used to prevent
cOVI0-19 and ®ed in accordancewi(h this Soope ofAuthorizatibn.(Section ll), outweigh its
know11 an<.t potential r:isk11,
I have concluded, pili"suiilitto Section 564(d)(3) ofthe Act1 based on the fotality, of scientific
evidence available t◊ EDA, that iris reasMableto believe that the Janssen COVID-19 Vaccine
may be effecti-ve in preventing COVll)-19 when used in accordance with this Scope of
Authorization {Section.ll), pur:sul!Iltto Section564(c)(:2)(A) ofthe Act.
Having reviewed the scientific mfonnatioriavailabietoFD~ including the iriforinati6n
Sll~porting the con:clusioll$ described in section tabove,. I have concluded that the Janssen
COVID-19 VMdne (as. described in this Scope of Authorizatfon (Section Il)) meets the criteria set
forthjnSection 564(i::) of the Actcon.cerni!lg safety and potel)tial ef.fectivenes~,
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Theerriergen:c.y i.tse 6fthe Jan..~sen: covm~19 vac.dne under this EUA must Be. COI1Sisteri:tWilh; arid
may not excee.~ thetenns oftheAuthorization, including the. Scope ofAµthorization (SeetionJt)
and the Conditi'ons of Authorization (Section, Ill). Subjectto the terms ofthisEUA and undei:the
circumstancegsetforthinthe8ecretaryofHHS'sdet.mninafionundetSection?64(b)0XC)
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28623
:eage 5 -Janssen Biotech, fuc.
described above and the Secretary ?fHHS's corresponding declaration under Section564(b)(l),the
Janssen CO~l9 Vaccine is authorized to ~verttCOVID-19 in. individtlll.ls l RJeMi of age and
older Mdescribed.inthe\Soope ofAuthmization(Sectio11 Il)oodetthls EU.A, despite the fact thatit
<loes not meet~ re~uir~ents~sere<i_uiredt,yappli~le federal J11,w, ·
fit
Concllitons otAuthotizittion
PursuanHo Section 564 oftheA.¢4lam-establishirtgthe foll~conditfol:lS onthls authoriz:dfon:
Janssen Biotech;fuc. and Authorized Distttl:;utor(s)
A )llJlS.sen: ;t3iotech. htc. andmrth-Orized distni>titot(s}wHi e:t1sute th:aiihe l)Uthotizecf
JanssenCOVID,I9Vaooineis distribute~ as directed bythe tr:S.govemment,
·mcludingCOOand/or•otherdesignee,and·theauthorizedlabeling(i.e,,FactSheets)
will be made available to vaccinationproviders,recipients,and. caregivers consistent
withthetettns otthls 1ettet.
· ·
lt JajlSsen l'.3ioteclt; Iiic, and lillthorjzed dwtrjbutof(s)vtjlJ. ~ that apptQpl"iate sf()rage
and cold chainis maintaineduritil deliveredfo·emergencyresponse stakeholders'
receipt sites.
<t JanssenBiotech. fuc,will ensurethatthtitermsQfthis:Etl'Aare.made 1tvaill\lifoJollll
t7elev;uit sfl!keh~deri, (e,g,; emer:gencyre11P9nse stakeh()fd~, .initll()rjzed4istril>utm11,
·and.vaccinationproviders)involv.edindistributihgorreceiving.the·authorized
Janssen:COVID-19 Vaccine.. Janssen Biotech, me. wiHprovidet◊ allrelevant
SWkeho1ders.·a.c<>pyofthisJett:er•ofmrth-Orizationand.cOitiifiunicateany stibs«J,tient
amendinen~that might bem~eto thisJetter ofauthorizaiiq11 and ru; authorized
l~eling;
VerDate Sep<11>2014
17:29 May 26, 2021
JanssenBiotech,. fuc.maydevefop and disseminate instructional and educational
materials(e.g.• ·videor~gatding'\'iiCCine:hand1ing;•storage/cold-chammanagenietit;
preparntion. 4tsp◊Sal)thatare:¢®istent..with.the· aut1torized:emet&en1;1yuse ofthe
vaccine as ~scribed in th:e letter ofauthorization and authorized labeling,·without
FDA's review and~oncurrence. when necessary to meetpublic health needs during
an emergency, Arty instructional and educational materia1s1hat are inconsistentwith
the authmized lii.b<£lingare prohibited.
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n
28624
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
Page 6-Janssen Biotech, me.
E, Janssen Biotech, Inc. may request changes to this authorization, including to the
authorized Fact Sheets fortheJanssenCOVID-19 Vaccine.. Artyrequestforchanges
to this EOAmustbe submitted to.the :Office ofVaccines Research and Review
(OVRR)/Centerfor Biologics Eyaluation and R:esearch (CBER). $uch changes.
require appropriate authorization prior to implementation. 7
F.
Janssen Biotech, Inc. will report toVitccihe Adverse Event Reporting Systetti.
(VAERS):
• Serious adverse events (m:espective of attribution: to vaccmat100);
• Cases ofMuhisystem Inflammatory Syndrome in adults; and
• Qises ofCOVID-l~thattesultm hospitalization or death, that arereportedfo
Janssen Biote.:h, Inc.
·
'these reports sh<>uld be submjtted to VAERS. as soon as possible but no l;J;tedhan
15 calendar days from initialreceipt ofthe infonnation by Janssen Biotech, Inc.
me..must submit to Jnvestigational New Dmg application (W:0)
number 22657 periodic safety reports at. monthly intervals in.:accotdance with a due
date agreed upon with the
of Bipsiatistics and Epidemiology(OBE)/CBER,
beginning after the first full calendar month after authorization, Each periodic safety
report istequired 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 sUinitiafyand analysis of vaccihe adtni:rtistiation ~:rs, whetherotnot
.associated with an adverse event;. that were identified since the l$1: reporting
interval
• Newly identified safety cortcetns in the interval; arni
• Adions takert. sihce the 1$1: report because of adverse experiences (:(or. ex:.ample,
changes.made to Healthcare Providers Admir!istering Vaccine{Vaccination
ProvidersJFact Shee~ changes made to studies or studies initiated}
G, Janssen Biotech,
Office
It No changes Will be implemented to the description ofthe product; martufa.cttiring
process,facilities, ur equipment vvitbout notification to and concmreµce by the
Agency.
r. AILmantifacturing facilities willcompiy with Coociit Good Manufacturing l'ractire
requirements.
may authorized
T~ following types of {\:Visions
be
Without reisllrung. this 1ettet (1) ciianges to the aµtl).otized
lilbelihg; (2) non-substantive editorial corrections to this letter; ~3) new types of: authorized labelihg, including r1ew
foot shee~ (4) new carton/contairter labels; (5) expiration datihg exteri$iOilS; (6) changes.t0: manufacturing
proce;ses.. including te\;ts or other authorized components of inanufactiirihg; (7) new collliiti® of authorizatil>rito
requite data colle1;tion Ot study, All chimgesto the authorization reqtiireteview and concurrence :froniQVRR For
changes to ¢.e .authormition,
the!iUthorizeli labelirtg'. ofthe type listed in (3), (6), or(:7); review imd
coilGurrtlnce is also reqtiirl:d from the Pteparedhess.~d Response Team (PREP)/Qffice of t4e Cen~r Director
(OD)/CBER and the .Office ofC~RD1terterrorism and Emerging :rbteats/Office of the Chlt!fScientist.
7
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28625
Page 7 -Janssen Biotech, Inc.
J. JanssenBiotech, Inc. will submitto the EUAfile Certitfoates of Anal)'Sis (CoA)for
eachclrug product lot at least48 ~ours prior~vaccine distribmion. The CoAwill
include the establ:ishedspecmcatfom lindspecific resoltsfotellch qliality controltest
peifOrtlled ontltefinal drugprodi;tctiot.
K. JanssenBioteo~ Inc, :will submitfothe EUArtle quarterlymanufacturingreports that
include a: li$tingofalLDrug Substance and Drug Productlots produced a:fief:issuance
ofthisauthorization, This reportmustinclude lotnuml)er, manufacturing site, ~ <>f
manuf~c.~. a:n:d lotdispQSitfon._ including thoselots that were quarantined for
investiglliion or those lots thalwere rejected.. Infonnation on·the reasons for lot
quarantine or rejection must be included in the report.. The first report.is dueJune l,
2021.
Le Jimssen Biotech, Inc, and authorized distribut-0r(s)witlmaintl!inrecords re,gardmg
release ofJanssen.COVID-19Vaccinefordistribution.(i.e,, lot numbers, quantity~
releaSe date),
M.. Ja$se11Biotech. fuc, •. and$1horizeddi$fributor(!iJWillmlikeavailable'.t◊.FDA.upon
t"eqµest 1111yrecords tnaintainel.1 in connectiQn wil;h ~ E:trA,
N: Janssen Biotec~.Jric~ wiii coriduct~ost--authoriiationobservatlorial stu(iiestoevafoate
the llS!i-Orjation between Jmssen C0vt049 Vaccifie artd apre-specifiedJist of
adverseeventsQfs~ciafinterest,. alongVl'ithl,ieatfu; andh<)spitalizations,and•seyere·
CO~ 19, 1he studypopajati9ri shoulliincfode im:ijviduals adtlutris~ the
authorized.Janssen COVID-19 Vaccine under this EUAin the generalU.&
population(l&years of·ageMdolder\ populatioriS. of interest such.llS:•healthcare
workers, ptegna11twomeri, itmnorioc:otnpromised indiviliual!l, subpopulations with
specific comt>rl>iditi~, The studies.should b.e conducted inJarge sca;Ie database$ with
an active comparator lii11.sset1Biotech. In:¢. will pmyide protocols and status update
reportstothe.IND22657with.agreed~uponstudy·designsand.milestone.dates.
Einergency·ResP@se·Stakehbiders
O;
·Emergency.responsestakeholders wiU.identifyvacrjnation•.sitesfo.•receive authorized
JanssenCOVID-19Vaccine..and ensureits distribution and administration, consistent
With the terms ofthis lettet andCDC~C():\m)..19 Vaccination Program.
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P,. Em~c.yresponsestak~hofdetSwill.•erisure.thatvaccinationptQviderswithintheir
jurisdictions are aware of.this letter of.authorization, andthetennsherein.and any
subsequent amendments that might be madeto the letter ofauthorization, ihstrtict
th~ abl'lut:the means through which they ateto obtafuandadministerthe vaccine
under the EPA, andertiiurethatthe authl'lrized labeling[i.e,,]'actSheet tor Heruthcare
l'rovi~At.lm~g Vaajrte(;Vaccination Proyi~)arili fact S!teetfor
Recipients and Caregivers] is madeavailabletovaccination providers through
appropriatemew(e.g.,·e-mait,website).
28626
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
P~ 8 -•Janssen Biotech, Inc.
Qi Emergencyresponse stakeholders receiving authorizedJanssen COVID-19:Vaccine
will.erl$ut,rthat apptoprlatestorage and.coldchainis>mitintairted:
Vaccination: Providers
R. Vaccinationprovidenrwill.adtninis~the vaccine in accordance with the
authorization and will participate.an&complywiththe tenns and 1raifimgt¢qi:tlred by
tDC's:CQVID-19\faccirtationPingtatn:;
K Viu::cinatfunprovidenrwillprovidetheFactSheetforRecipierits and Caregivers to
eru:fr fudi:vidual teooi'vmg vl¢cinatiott
·
t. \fiu;qinatiQt1 providers ~$terirtgthe JamisetiOO\ttr).:12 Vaccin,e must~PQri:the
following information,associatedwiththe adininistration ofthe Janssen CQVII)~ f9:
·v,accine.ofwhichtheybecomeawareto VAERS inaccordance withthe Fact Sheet
for Healthcate ProvidersAdmiriister~ Vaccihe(Vacelllation Providera):
• Vaccine administration errors whether,or notassociated·wifh.an adverse event
• $erious !l4vers.e eyents: (irrespective ofaitribution to vaccihatron:)
• Cases.ofMult1system Inflafimiatofy Syndrotiie in adults
•· Cases of09V:ID- PHhat resultih.ltQspitalizatioµ 9r: death:
Complete iifid submit reports to VAERSonlirte at
https://vaers.'hhs,~oy/r~orteyent.htnit The\(AER$ t¢potfS shou1dihclu~ the
wotdi\ ••J@ssenCdViD~l9 Vaccine l?.UA:' ihthe description section 6f:theteport
Moreinfmm:atiohis avaitabte atvaers.hhs,gov ot~y callihgl•800..:&22~7967. To
the exteritfeasible, report to Janssen Biotech, Inc. by contacting 1..:800•565--4008
·~ bypro'vi(,ling.!lcopy9fthe VAERSfoOlltg Janss~n Biotech, Ihc,;fax: 2L5293'-~$$, or b:Y emaiL,,ffiJyaccin~A:e@its..jnj.com;
tt Vaccination providers will Ct>rtduct any roll<>wauprequestedbythe t)'.S,
g<>:vemment; foc1udfug <::DC, EDA. -0r otherdesignee; tegatdmg ad:verse events to
the extentf'easiol:e given the em:~ni:ly'cttcumstartces.
V; ·vaccination providers will monitorandcomplywithCDC and/or emergency
.response stakeholder vaccine managementreqwremefits (~:g,, requirements
concemit1g obtaitlmg.·tr11,Clcingt.~<l handlin~yaccine)~4with x:eqµifemew:~·
concetrting ~pQttin;g:of'vacciheadministtatlon: dlitato COO.:
W; Vacciriatiohproviderswiii ensure thatanyrecords associated Willi t1tis EDA ate
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maintained until.notified by FDA. Such records willbemadeavailableto CDC,
and.FDJ\;for inspection upon request,
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28627
Page 9 -Janssen Biotech, Inc,
ConditlonsR'elatedto:Printed Matt.er2Advertising, and Promotion
:X, ~1~9rlptive ~ d tllllfter; ad'v¢ish1& l!ll4 pr9motional:m$rial,,rela:tingto the
'.lJse ofthe. Janssen COVIJ),19 VaccineshalLbe consist.eritwiththe auihorizedlabeling; as .well.as.the tenns setforth in this EUA, and.meet the requirements-set
fu.rth in section '502(a)and(rt) ofthe FD&C Act and FDA inlplementingt!:lgufatforts.
Y: t'\l.f®Scripiivepririted matter; advertisih~ and promi>tioruiltn$rialrelaiing.fu the:
useoftheJanssenCOVID~l9Vaccinecleadyandconspicuouslyshallstahdhah
,., 'J'lili; prO<lucthas nlltbeet1 llPWQVed or !iCetlSetJ;by FDA, bufhas l>eet1,
auihorizedforemergency.us-e·by FDA, under an ·EUAto prevent Coronaviius
-~~~~~:
®¢111¢ionis tennhtated oraµthorizirtion revoke,d soo.ner.
IV;c
1'uratioitotA:uth.orization.
This EUA :wiffbe effe~ve until the declarationthat\cfrcumsta.m;es exist.justifyingthe
authorization ofthe emergencyuse.·ofdrugs and. biological products during the COVID'-il9
~=~:::;~:nated under Section ,64(h)(2) ~f'the Act or the ·suA ill reV◊ked untfut Section
RADM Denise M. Hinton
ChiefScientist
Food-.and Drug·,Attministtatiro.
Enclosures
[FR Doc. 2021–11234 Filed 5–26–21; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1136]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
SUMMARY:
VerDate Sep<11>2014
17:29 May 26, 2021
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Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
The announcement of the
guidances is published in the Federal
Register on May 27, 2021.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
PO 00000
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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.
E:\FR\FM\27MYN1.SGM
27MYN1
EN27MY21.018</GPH>
Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
]]>Agencies
[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28608-28627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0335]
Authorizations of Emergency Use of Certain Biological Products
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 two Emergency Use Authorizations (EUAs) (the
Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) for biological products for use during the COVID-19 pandemic. FDA
has issued one Authorization for biological products as requested by
Eli Lilly and Company and one Authorization for a biological product as
requested by Janssen Biotech, Inc. The Authorizations contain, among
other things, conditions on the emergency use of the authorized
products. The Authorizations follow 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 Authorizations, which include an explanation of the
reasons for issuance, are reprinted in this document.
DATES: The Authorization for Eli Lilly and Company is effective as of
February 9, 2021, and the Authorization for Janssen Biotech, Inc. is
effective as of February 27, 2021.
ADDRESSES: Submit written requests for single copies of the EUAs 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 Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
[[Page 28609]]
section for electronic access to the Authorizations.
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.
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, 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), 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 Authorizations
The Authorizations follow 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 Authorizations under
section 564(c) of the FD&C Act are met, FDA has issued two
authorizations for the emergency use of biological products during the
COVID-19 pandemic. On February 9, 2021, FDA issued an EUA to Eli Lilly
[[Page 28610]]
and Company for bamlanivimab and etesevimab, administered together,
subject to the terms of the Authorization. On February 27, 2021, FDA
issued an EUA to Janssen Biotech, Inc. for the Janssen COVID-19
Vaccine, subject to the terms of the Authorization. The initial
Authorizations, which are included below in their entirety after
section IV of this document (not including the authorized versions of
the fact sheets and other written materials), provide an explanation of
the reasons for issuance, as required by section 564(h)(1) of the FD&C
Act. Any subsequent reissuances of these Authorizations can be found on
FDA's web page: 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
Authorizations and are 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: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11234 Filed 5-26-21; 8:45 am]
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