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FDA-CBER-2021-5683-0951247
FDA-CBER-2021-5683-0951248
FDA-CBER-2021-5683-0951249
August 23, 2021
Pfizer Inc. Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426 Dear Ms. Harkins: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Fe deral Food, Drug, and Cosmetic
Act (the FD&C Act or the Act) , the Secretary of the Department of Health and Human Services
(HHS) determined that there is a public health emergency that h as a significant po tential to affect
national security or the health and security of United States c itizens living abroad, and that
involves the virus that causes Coronavirus Disease 2019 (COVID- 19).
1 On the basis of such
determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist
justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant t o Section 564 of the Act (21 U.S.C . 360bbb-3), subject to terms
of any authorization i ssued under that section.
2
On December 11, 2020, the Food and Drug Administration (FDA) is sued an Emergency Use
Authorization (EUA) for e mergency use of Pfizer- %LR17HFK &29,'ဩ 9DFFLQH IRU the
prevention of COVID-19 for indiv iduals 16 years of age and older pursuant to Section 564 of the
Act. FDA reissued the letter of authorization on: December 23, 2020,
3 February 25, 2021,4 May
1 U.S. Department of Health and Human Services, Determination of a Public Health Emergen cy and Declaration that
Circumstances Exist Justifying Authorizations Pursuant to Secti on 564(b) of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. § 360bbb- 3. February 4, 2020.
2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations
Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3 , 85 FR 18250
(April 1, 2020).
3 In the December 23, 2020 revision, FDA removed reference to th e number of doses per vial after dilution from the
letter of authorization, clari fied the instructions for vaccina tion providers reporting to VAERS, and made other
technical corrections. FDA also revised the Fact Sheet for Hea lthcare Providers Administering Vaccine
(Vaccination Providers) to clari fy the number of doses of vacci ne per vial after dilution and the instructions for
reporting to VAERS. In additi on, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination
Providers) and the Fact Sheet for Recipients and Caregivers were revised to include additional information on safety monitoring and to clarify information about the availability of other COVID-19 vaccines.
4 In the February 25, 2021 revision, FDA allowed flexibility on the date of submission of monthly periodic safety
reports and revised the require ments for report ing of vaccine a dministration errors by Pfizer Inc. The Fact Sheet for
Health Care Providers Administe ring Vaccine (Vaccination Provid ers) was revised to provide an update to the
storage and transportation temperature for frozen vials, direct the provider to the correct CDC website for
information on monitoring vaccine recipients for the occurrence of immediate adverse reactions, to include data
from a developmental toxicity s tudy, and add adverse reactions that have been identified during post authorization
use. The Fact Sheet for Recipient s and Caregivers was revised to add adverse reactions t hat have been identified
during post authorization use.
FDA-CBER-2021-5683-0951250
Page 2 – Pfizer Inc.
10, 2021,5 June 25, 2021,6 and August 12, 2021.7
On August 23, 2021, FDA approved the bi ologics license applicat ion (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in indivi duals 16 years of age and
older. On August 23, 2021, having concluded tha t revising this EUA is appropriate to protect the public
health or safety under section 564 (g)(2) of the Act, FDA is rei ssuing the August 12, 2021 letter
of authorization in its entirety w ith revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previous ly-authorized indication and
uses, and to authorize use of C OMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not incl uded in the approved BLA. In addition, the Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Provide rs) was revised to provide
updates on expiration dating of the a uthorized Pfizer-BioNTech COVID-19 Vaccine and to
update language regarding warnings and precautions related to m yocarditis and pericarditis. The
Fact Sheet for Recipients and Caregivers was updated as the Vac cine Information Fact Sheet for
Recipients and Caregivers, whic h comprises the Fact Sheet for the authorized Pfizer-BioNTech
COVID-19 Vaccine and informati on about the FDA-licensed vaccine, COMIRNATY (COVID-
19 Vaccine, mRNA). Pfizer-%LR17HFK&29,'ဩ 9DFFLQH contains a nucleoside-m odified messenger RNA
(modRNA) encoding the viral spike (S ) glycoprotein of SARS-CoV- 2 formulated in lipid
particles. COMIRNATY (COVID-19 V accine, mRNA) is the same form ulation as the Pfizer-
BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech
COVID-19 Vaccine to provide the COVID-19 vaccination series.
8
5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech V accine for the prevention of COVID-19 in
individuals 12 through 15 years of age, as well as for individu als 16 years of age and older. In addition, FDA
revised the Fact Sheet for Healt hcare Providers Administering V accine (Vaccination Prov iders) to include the
following Warning: “Syncope (fainting) may occur in association with administration of injectable vaccines, in
particular in adolescents. Pro cedures should be in place to av oid injury from fainting.” In addition, the Fact Sheet
for Recipients and Caregivers was revised to instruct vaccine r ecipients or their caregiver s to tell the vaccination
provider about fainting in association with a previous injectio n.
6 In the June 25, 2021 revision, FDA clarified terms and conditi ons that relate to export of Pfizer-BioNTech
&29,'ဩ 9DFFLQH IURP WKH8QLWHG6WDWHV In addition, the Fact Sheet for Healthcare Providers Administe ring
Vaccine (Vaccination Pr oviders) was revised to include a Warning about myocarditis and pericarditis following
administration of the Pfizer-Bio NTech COVID-19 Vaccine. The Fa ct Sheet for Recipients and Caregivers was
updated to include information about myocarditis and pericardit is following administration of the Pfizer-BioNTech
&29,'ဩ 9DFFLQH
7 In the August 12, 2021 revision, FDA authorized a third dose o f the Pfizer-BioNTech COVID-19 Vaccine
administered at least 28 days fo llowing the two dose regimen of this vaccine in individuals 12 years of age or older
who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with
conditions that are considered to have an equivalent level of i mmunocompromise.
8 The licensed vaccine has the sam e formulation as the EUA-autho rized vaccine and the products can be used
interchangeably to provide the v accination series without prese nting any safety or effectiveness concerns. The
products are legally distinct with certain differences that do not impact safety or effectiveness.
FDA-CBER-2021-5683-0951251
Page 3 – Pfizer Inc.
For the December 11, 2020 authoriz ation for individuals 16 years of age and older, FDA
reviewed safety and efficacy d ata from an ongoing phase 1/2/3 trial in approximately 44,000
participants randomized 1:1 to receive Pfizer-BioNTech &29,'ဩ 9 accine or saline control.
The trial has enrolled particip ants 12 years of age and older. FDA’s review at that time
considered the safety and effectiv eness data as they relate to the request for emergency use
authorization in individuals 16 years of age and older. FDA’s review of the available safety data
from 37,586 of the participants 16 y ears of age and older, who were followed for a median of
two months after receiving the s econd dose, did not identify sp ecific safety concerns that would
preclude issuance of an EUA. FDA’s analysis of the available e fficacy data from 36,523
participants 12 years of age and ol der without evidence of SARS -CoV-2 infection prior to 7 days
after dose 2 confirmed the vaccine was 95% effective (95% credible interval 90.3, 97.6) in preventing COVID-19 occurring at least 7 days after the second dose (with 8 COVID-19 cases in
the vaccine group compared to 162 COVID-19 cases in the placebo group). Based on these data,
and review of manufacturing inf ormation regarding product quali ty and consistency, FDA
concluded that it is reasonable to believe that Pfizer- %LR17HFK&29,'ဩ 9DFFLQH may be
effective. Additionally, FDA dete rmined it is reasonable to conclude, based on the totality of the
scientific evidence availabl e, that the known and potential ben efits of Pfizer-BioNTech
&29,'ဩ 9DFFLQH outweigh the known and potential r isks of the vaccine, for the prevention of
COVID-19 in individuals 16 years of age and older. Finally, on December 10, 2020, the
Vaccines and Related Biological Products Advisory Committee vot ed in agreement with this
conclusion. For the May 10, 2021 authorizati on for individuals 12 through 1 5 years of age, FDA reviewed
safety and effectiveness data f rom the above-referenced, ongoin g Phase 1/2/3 trial that has
enrolled approximately 4 6,000 participants, including 2,260 par ticipants 12 through 15 years of
age. Trial participants were ra ndomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or
saline control. FDA’s review of t he available s afety data from 2,260 participants 12 through 15
years of age, who were followed f or a median of 2 months after receiving the second dose, did
not identify specific safety c oncerns that would preclude issua nce of an EUA. FDA’s analysis of
SARS-CoV-2 50% neutralizing antib ody titers 1 month after the s econd dose of Pfizer-
BioNTech COVID-19 Vaccine in a s ubset of participants who had n o serological or virological
evidence of past SARS-CoV-2 infection confirm the geometric mea n antibody titer in
participants 12 through 15 years of age was non-inferior to the geometric mean antibody titer in
participants 16 through 25 years of age. FDA’s analysis of available descriptive efficacy data
from 1,983 participants 12 through 1 5 years of age without evid ence of SARS-CoV-2 infection
prior to 7 days after dose 2 confirm that the v
accine was 100% effective (95% confidence
interval 75.3, 100.0) in preventi ng COVID-19 occurring at least 7 days after the second dose
(with no COVID-19 cases in the vacc ine group compared to 16 COV ID-19 cases in the placebo
group). Based on these data, FDA co ncluded that it is reasonab le to believe that Pfizer-
%LR17HFK &29,'ဩ 9DFFLQHPD\EH HIIHFWLYHLQ LQGLYLGXDOV WK URXJK \HDUV RI DJH
Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific
evidence available, that the known and potential benefits of Pfizer-%LR17HFK &29,'ဩ
Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19
in individuals 12 thr ough 15 years of age.
FDA-CBER-2021-5683-0951252
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For the August 12, 2021 authorizatio n of a third dose of the Pf izer-BioNTech COVID-19
Vaccine in individuals 12 years of age or older who have underg one solid organ transplantation,
or individuals 12 years of age or older who are diagnosed with conditions that are considered to
have an equivalent level of imm unocompromise, FDA reviewed safe ty and effectiveness data
reported in two manuscripts on so lid organ transplant recipient s. The first study was a single
arm study conducted in 101 individu als who had undergone various solid organ transplant
procedures (heart, kidney, liver , lung, pancreas) a median of 9 7±8 months earlier. A third dose
of the Pfizer-BioNTech COVID- 19 Vaccine was administered to 99 of these individuals
approximately 2 months after they had received a second dose. Levels of total SARS-CoV-2
binding antibodies meeting the pre-specified criteria for succe ss occurred four weeks after the
third dose in 26/59 (44.0%) of those who were initially considered to be seronegative and
received a third dose of the Pfizer-BioNTech COVID-19 Vaccine; 67/99 (68%) of the entire
group receiving a third vaccination were subsequently considere d to have levels of antibodies
indicative of a significant r esponse. In those who received a third vaccine dose, the adverse
event profile was similar to that after the second dose and no grade 3 or grade 4 events were
reported. A supportive secondar y study describes a double-blin d, randomized-controlled study
conducted in 120 individuals who had undergone various solid organ transplant procedures
(heart, kidney, kidney-pancreas, liver, lung, pancreas) a median of 3.57 years earlier (range 1.99-
6.75 years). A third dose of a sim ilar mRNA vaccine (the Moderna COVID-19 vaccine) was
administered to 60 individuals approximately 2 months after they had received a second dose (i.e., doses at 0, 1 and 3 months); s aline placebo was given to 60 individuals or comparison. The
primary outcome was anti-RBD antibody at 4 months greater than 100 U/mL. This titer was
selected based on NHP challenge st udies as well as a large clin ical cohort study t o indicate this
antibody titer was protective. Sec ondary outcomes were based on a virus neutralization assay
and polyfunctional T cell respons es. Baseline ch aracteristics were comparable between the two
study arms as were pre-interven tion anti-RBD titer and neutrali zing antibodies. Levels of total
SARS-CoV-2 binding antibodies indicative of a significant respo nse occurred four weeks after
the third dose in 33/60 (55.0%) of the Moderna COVID-19 vaccina ted group and 10/57 (17.5%)
of the placebo individuals. In t he 60 individuals who received a third vaccine dose, the adverse
event profile was similar to t hat after the second dose and no grade 3 or grade 4 adverse events
were reported. Despite the mode rate enhancement in antibody tit ers, the totality of data (i.e.,
supportive paper by Hall et al. demonstrated efficacy of the pr oduct in the elderly and persons
with co-morbidities) supports t he conclusion that a third dose of the Pfizer-Moderna COVID-19
vaccine may be effective in this population, and that the known and potential benefits of a third dose of Pfizer-BioNTech COVID-1 9 Vaccine outweigh the known and potential risks of the
vaccine f
or immunocompromised ind ividuals at least 12 years of age who have received two
doses of the Pfizer-BioNTech COVID-19 Vaccine and who have undergone solid organ transplantation, or who are dia gnosed with conditi ons that are considered to have an equivalent
level of immunocompromise. Having concluded that the criteria for issuance of this authori zation under Section 564(c) of the
Act are met, I am authorizi ng the emergenc y use of Pfizer-%LR17HFK&29,'ဩ 9DFFLQH for the
prevention of COVID-19, as descri bed in the Scope of Authorization section of this letter
(Section II) and subject to the terms of this authorization. A dditionally, as specified in
subsection III.BB, I am authoriz ing use of COMIRNATY (COVID-19 Vaccine, mRNA) under
this EUA when used to provide a t wo-dose regimen for individuals aged 12 through 15 years, or
FDA-CBER-2021-5683-0951253
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to provide a third dose to individuals 12 years of age or older who have undergone solid organ
transplantation or who are diagnosed with conditions that are c onsidered to have an equivalent
level of immunocompromise.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer- %LR17HFK&29,'ဩ 9DFFLQH for the
prevention of COVID-19 when admin istered as described in the Sc ope of Authorization (Section
II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:
A. SARS-CoV-2 can cause a serious or life-threaten ing disease or condition, including
severe respiratory illness, to humans infected by this virus;
B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that Pfizer- %LR17HFK &29,'ဩ 9DFFLQH may be effective in preventing COVID-19,
and that, when used under the c onditions described in this auth orization, the known and
potential benefits of Pfizer- %LR17HFK&29,'ဩ 9DFFLQH when used to prevent
COVID-19 outweigh its known a nd potential risks; and
C. There is no adequate, approved, and available
9 alternative to the emergency use of
Pfizer-%LR17HFK&29,'ဩ 9DFFLQH to prevent COVID-19.10
II. Scope of Authorization
I have concluded, pursuant to Sec tion 564(d)(1) of the Act, tha t the scope of this authorization is
limited as follows:
x Pfizer Inc. will supply Pfizer-%LR17HFK&29,'ဩ 9DFFLQH either direc tly or through
authorized dis tributor(s),
11 to emergency response stakeholders12 as directed by the U.S.
9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years
of age and older, there is not sufficient approved vaccine avai lable for distribution to this population in its entirety at
the time of reissuance of this EU A. Additionally, there are no products that are approved to prevent COVID-19 in
individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised
population described in this EUA.
10 No other criteria of issuance have been prescribed by regulati on under Section 564(c)(4) of the Act.
11 “Authorized Distributor(s)” are identified by Pfizer Inc. or, if applicable, by a U.S. gov ernment entity, such as the
Centers for Disease Control and Prevention (CDC) and/or other d esignee, as an entity or entities allowed to
distribute authorized Pfizer-BioNTec K &29,'ဩ 9DFFLQH
12 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates
that have legal responsibility and authority for responding to an incident, based on political or geographical
boundary lines (e.g., city, coun ty, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public
health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some
cases (e.g., depending on a state or local jurisdiction’s COVID -19 vaccination response organization and plans),
there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination
providers” (e.g., if a local heal th department is administering COVID-19 vaccines; if a pharmacy is acting in an
FDA-CBER-2021-5683-0951254
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government, including the Centers for Disease Control and Preve ntion (CDC) and/or
other designee, for use consistent with the terms and condition s of this EUA;
x The Pfizer- %LR17HFK &29,'ဩ 9DFFLQH covered by this authorization will be
administered by vaccination providers13 and used only to prevent COVID-19 in
individuals ages 12 and older; and
x Pfizer-%LR17HFK&29,'ဩ 9DFFLQH may be administered by a vaccination provider
without an individual prescrip tion for each vaccine recipient.
This authorization also cove rs the use of the licensed COMIRNATY (COVID-19 Vaccine,
mRNA) product when used to provide a two-dose regimen for indiv iduals aged 12 through 15
years, or to provide a third dose to individuals 12 years of ag e or older who have undergone solid
organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Product Description The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride In jection, USP
prior to use to form the vaccine. The Pfizer-BioNTech COVID-19 Vaccine does not contain a
preservative. Each 0.3 mL dose of the Pfizer-Bi oNTech COVID-19 Vaccine contai ns 30 mcg of a nucleoside-
modified messenger RNA (modRNA) e ncoding the viral spike (S) gl ycoprotein of SARS-CoV-2.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients:
lipids (0.43 mg (4-hydro xybutyl)azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg
2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 m g 1,2-distearoyl-sn-glycero-3-
phosphocholine, and 0.2 mg choleste rol), 0.01 mg potassium chloride, 0.01 mg monobasic
potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate,
and 6 mg sucrose. The diluent (0.9 % Sodium Chloride Injection) contributes an additional 2.16
mg sodium chloride per dose.
official capacity under the autho rity of the stat e health depar tment to administer COVID-19 vaccines). In such
cases, it is expected that the co nditions of authorization that apply to emergency response stakeholders and
vaccination providers will all be met.
13 For purposes of this letter, “v accination provider” refers to the facility, organization, or healthcare provider
licensed or otherwise authorized by the emergency response stak eholder (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 administer or provi de vaccination services in accor dance with the applicable emergency response
stakeholder’s officia l COVID-19 vaccination and emergency respo nse plan(s) and who is enrolled in the CDC
COVID-19 Vaccination Program. If the vaccine is exported from t he United States, a “vac cination provider” is a
provider that is authorized to administer this vaccine in accor dance with the laws of the country in which it is
administered. For purp oses of this letter, “healthcare provider ” also refers to a person authorized by the U.S.
Department of Health and Human Services (e.g., under the PREP A ct Declaration for Medi cal Countermeasures
against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and
State-authorized pharmacy inte rns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth
Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration . 85 FR 79190 (December 9, 2020).
FDA-CBER-2021-5683-0951255
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The dosing regimen is two doses of 0.3 mL each, 3 weeks apart. A third dose may be
administered at least 28 days following the second dose of the two dose regimen of this vaccine
to individuals 12 years of age or older who have undergone solid organ transplantation, or
individuals 12 years of age or ol der who are diagnosed with con ditions that are considered to
have an equivalent level of immunocompromise.
The manufacture of th e authorized Pfizer- %LR17HFK &29,'ဩ 9DFFLQH is limited to those
facilities identified and agree d upon in Pfizer’s request for a uthorization.
The Pfizer-BioNTech COVID-19 Vacci ne vial label and carton labe ls are clearly marked for
“Emergency Use Authorization.” The Pfizer- %LR17HFK&29,'ဩ Vaccine is authorized to be
distributed, stored, further re distributed, and a dministered by emergency response stakeholders
when packaged in the authorized m anufacturer packaging (i.e., vials and cartons), despite the
fact that the vial a nd carton labels may not contain informatio n that otherwise would be required
under the FD&C Act. Pfizer-%LR17HFK&29,'ဩ 9DFFLQH is authorized for emergency use with the following
product-specific information re quired to be made available to v accination providers and
recipients, respectively (referre d to as “authorized labeling”) :
x Fact Sheet for Healthcare Provi ders Administering Vaccine (Vacc ination Providers):
Emergency Use Authorization (EUA) of Pfizer- %LR17HFK &29,'ဩ 9DFFLQH to Prevent
Coronavirus Disease 2019 (COVID-19)
x Vaccine Information Fact Sheet for Recipients and Caregivers Ab out COMIRNATY
(COVID-19 Vaccine, mRNA) and Pfize r-BioNTech COVID-19 Vaccine to Prevent
Coronavirus Disease (COVID-19).
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Pfizer- %LR17HFK&29,'ဩ 9DFFLQH , when used to prevent
COVID-19 and used in accordance w ith this Scope of Authorizatio n (Section II), outweigh its
known and potential risks. I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe tha t Pfizer-%LR17HFK&29,'ဩ
Vaccine may be effective in prev enting COVID-19 when used in ac cordance with this Scope of
Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.
Having reviewed the scientific information available to FDA, in cluding the information
supporting the conclusions described in Section I a bove, I have concluded that Pfizer-BioNTech
&29,'ဩ 9DFFLQH (as described in this Scope of Authorization (Section II)) mee ts the criteria set
forth in Section 564(c ) of the Act concerning safety and potent ial effectiveness.
The emergency use of Pfizer-%LR17HFK&29,'ဩ 9DFFLQH under this EUA must be consistent
with, and may not exceed, the term s of the Authorization, inclu ding the Scope of Authorization
(Section II) and the C onditions of Authoriz ation (Section III). Subject to the terms of this EUA and
FDA-CBER-2021-5683-0951256
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under the circumstances set forth in the Secret ary of HHS’s determination under Section
564(b)(1)(C) described above and t he Secretary of HHS’s corresp onding declaratio n under Section
564(b)(1), Pfizer- %LR17HFK&29,'ဩ 9DFFLQH is authorized to prevent COVID-19 in individuals
12 years of age and olde r as described in the Scope of Authorization (Section II) under this EUA,
despite the fact tha t it does not meet cert ain requirements otherwise required by applicable federal
law.
III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the follo wing conditions on this authorization:
Pfizer Inc. and Autho rized Distributor(s)
A. Pfizer Inc. and authorized distributor(s) will ensure that the authorized Pfizer-
%LR17HFK&29,'ဩ 9DFFLQH is distributed, as directed by the U.S. government,
including CDC and/or other desig nee, and the authorized labelin g (i.e., Fact Sheets)
will be made avai lable to vaccination providers, recipients, an d caregivers consistent
with the terms of this letter.
B. Pfizer Inc. and authorized distributor(s) will ensure that appr opriate storage and cold
chain is maintained un til delivered to emer gency response stakeholders’ receipt sites.
C. Pfizer Inc. will ensure that the terms of this EUA are made ava ilable to all relevant
stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Pfizer-
%LR17HFK&29,'ဩ 9DFFLQH . Pfizer Inc. will provide to all relevant stakeholders a
copy of this letter of authorization and c ommunicate any subsequent amendments that
might be made to this letter of authorization and its authorize d labeling.
D. Pfizer Inc. may develop and disseminate instructional and educa tional materi als (e.g.,
video regarding vaccine handling, storage/cold-chain management , preparation,
disposal) that are consistent wi th the authorized emergency use of the vaccine as
described in the let ter of authorization and autho rized labelin g, without FDA’s review
and concurrence, when necessar y to meet public he alth needs dur ing an emergency.
Any instructional and ed ucational materials that are inconsiste nt with the authorized
labeling are pr ohibited.
E. Pfizer Inc. may request changes to this authorization, includin g to the authorized Fact
Sheets for the vacci ne. Any request for changes to this EUA must be submitted to
Office of Vaccines Research and Review (OVRR) /Center for Biologics Evaluation
and Research (CBER). Such changes require appropriate authoriz ation prior to
implementation.
14
14 The following types of revisions may be authorized without rei ssuing this letter: (1) changes to the authorized
labeling; (2) non-substantive editorial corrections to this let ter; (3) new types of authorized labeling, including new
fact sheets; (4) new carton/container labels; (5) expiration da ting extensions; (6) changes to manufacturing
FDA-CBER-2021-5683-0951257
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F. Pfizer Inc. will repo rt to Vaccine Adverse Event Reporting Syst em (VAERS):
x Serious adverse events (irrespec tive of attribution to vaccinat ion);
x Cases of Multisystem Inflammatory Syndrome in children and adul ts; and
x Cases of COVID-19 that result in hospitalizati on or death, that are reported to
Pfizer Inc.
These reports should be submitte d to VAERS as soon as possible but no later than
15 calendar days fro m initial receipt of the information by Pfi zer Inc.
G. Pfizer Inc. must submi t to Investigational New Drug a pplication (IND) number
19736 periodic safety reports at monthly intervals in accordance with a due date
agreed upon with the O ffice of Biostatisti cs and Epidemiology ( OBE)/CBER
beginning after the fir st full calendar mont h after authorizati on. Each periodic safety
report is required to contain desc riptive informat ion which inc ludes:
x A narrative summary and analysi s of adverse even ts submitted du ring the
reporting interval, including interval a nd cumulative counts by age groups, special
populations (e.g., pregnant women) , and adverse ev ents of speci al interest;
x A narrative summary and analysis of vaccine administration erro rs, whether or
not associated with an adverse event, that were identified since the last reporting
interval;
x Newly identified sa fety concerns in the interval; and
x Actions taken since the last rep ort because of adverse experien ces (for example,
changes made to Healthcare Provi ders Administeri ng Vaccine (Vaccination
Providers) Fact Sheet, changes made to studies or studies initiated).
H. No changes will be implemented to the descripti on of the produc t, manufacturing
process, facilit ies, or equipment withou t notification to and
concurrence by FDA.
I. All manufacturi ng facilities will comply with Current Good Manu facturing Practice
requirements.
J. Pfizer Inc. will submit to the EUA file Certificates of Analysi s (CoA) for each drug
product lot at least 48 hours prior to va ccine distribution. The CoA will include the
established specific ations and specific results for each qualit y control test performed
on the final drug product lot.
K. Pfizer Inc. will submit to the EU A file quarterl y manufacturing reports, starting in
July 2021, that include a listi ng of all Drug Substance and Dru g Product lots
produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, a nd lot disposition, i ncluding those lots that
processes, including tests or other authorized components of ma nufacturing; (7) new conditions of authorization to
require data collection or study. For changes to the authoriza tion, including the authorized labeling, of the type
listed in (3), (6), or (7), revi ew and concurrence is required from the Preparedness and Response Team
(PREP)/Office of the Center Dir ector (OD)/CBER and the Office o f Counterterrorism and Emerging Threats
(OCET)/Office of the Ch ief Scientist (OCS).
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were quarantined for i nvestigation or those lots that were rejected. Information on the
reasons for lot quaran tine or rejection must be included in the report.
L. Pfizer Inc. and author ized distributor(s) will maintain records regarding release of
Pfizer-BioNTech &29,'ဩ 9DFFLQH for distributio n (i.e., lot num bers, quantity,
release date).
M. Pfizer Inc. and authoriz ed distributor(s) will make available t o FDA upon request any
records maintained in co nnection with this EUA.
N. Pfizer Inc. will conduct post-a uthorization obser vational studies to evaluate the
association between Pfizer-Bio NTech COVID-19 Vaccine and a pre- specified list of
adverse events of sp ecial interest, along with deaths and hospi talizations, and severe
COVID-19. The study population should include individuals admi nistered the
authorized Pfizer-BioNTech COVID- 19 Vaccine under this EUA in the general U.S.
population (12 years of age and ol der), populations of interest such as healthcare
workers, pregnant women, immunocompromised individuals, subpopu lations with
specific comorbidities . The studies should be conducted in large scale databases with
an active comparator. Pfizer Inc. will provide protocols and s tatus update reports to
the IND 19736 with agree d-upon study designs and milestone date s.
Emergency Response Stakeholders
O. Emergency response stakeholders will identify vaccination sites to receive authorized
Pfizer-%LR17HFK&29,'ဩ 9DFFLQH and ensure its distribu tion and administration,
consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.
P. Emergency response stakeholders will ensure that vaccination pr oviders within their
jurisdictions are aware of this letter of authorization, and the terms herein and any subsequent amendments that might be made to the letter of autho rization, instruct
them about the means through which they are to ob tain and admin ister the vaccine
under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare Providers Administering Vaccine (Vaccina tion Providers ) and Vac cine Information
Fact Sheet for Recipients and Car egivers] is made available to vaccination providers
through appropriate means ( e.g., e-mail, w ebsite).
Q. Emergency response s takeholders receiving authorized Pfizer- %LR17HFK&29,'ဩ
Vaccine will ensure that approp riate storage an d cold chain is maintained.
Vaccination Providers
R. Vaccination providers will admin ister the vaccin e in accordance with the
authorization and will participat e and comply wit h the terms an d training required by
CDC’s COVID-19 Vaccination Program.
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S. Vaccination providers will provide the Vacc ine Information Fact Sheet for Recipients
and Caregivers to each individual receiving vaccination and pro vide the necessary
information for recei ving their second dose and/or third dose.
T. Vaccination providers administering the vaccine must report the following
information associated with the administration of the vaccine o f which th ey become
aware to VAERS in accordance wit h the Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers):
x Vaccine administration errors w hether or not associated with an adverse event
x Serious adverse events (irrespec tive of attribution to vaccinat ion)
x Cases of Multisystem Inflammatory Syndrome in children and adul ts
x Cases of COVID-19 that result in hospitalizati on or death
Complete and submit reports to VAERS online at
https://vaers.hhs.gov/reportevent .html. The VAERS reports should include the
words “Pfizer-%LR17HFK&29,'ဩ 9DFFLQH EUA” in the description section of
the report. More information i s available at vaers.hhs.gov or by calling 1-800-822-
7967. To the extent feasible, re port to Pfizer Inc. by contact ing 1-800-438-1985 or
by providing a copy of the VAERS for m to Pfizer Inc.; Fax: 1-86 6-635-8337.
U. Vaccination providers will conduct any follow-up requested by t he U.S
government, including CDC, FDA, o r other designee, regarding ad verse events to
the extent feasible given th e emergency circumstances.
V. Vaccination providers will monito r and comply with CDC and/or e mergency
response stakeholder vaccine man agement requirements (e.g., req uirements
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 w ith this EUA are
maintained until notified by FDA. Such records will be made av ailable to CDC,
and FDA for inspection upon request.
Conditions Related to Printed Matter, Advertising, and Promotio n
X. All descriptive printed matter, advertising, and promotional ma terial, relating to the
use of the Pfizer- %LR17HFK&29,'ဩ 9DFFLQH shall be consistent with the
authorized labeling, as well as the 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 the
use of the Pfizer- %LR17HFK&29,'ဩ 9DFFLQH clearly and conspicu ously shall state
that:
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x This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Co ronavirus
Disease 2019 (COVID-19) for use in individua ls 12 years of age and older; and
x The emergency use of this product is only a uthorized for the du ration of the
declaration that circumstances exist justifying the authorizati on of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
Condition Related to Export
Z. If the Pfizer- %LR17HFK&29,'ဩ 9DFFLQH is exported from the United States,
conditions C, D, and O through Y do not apply, but export is permitted only if 1) the
regulatory autho rities of the c ountry in which the vaccine will be used are fully
informed that this vaccine is s ubject to an EUA and is not approved or licensed by
FDA and 2) the intended use of the vaccine will comply in all r espects with the laws
of the country in which the product will be used. The requirem ent in this letter that
the authorized labeling (i.e., Fac t Sheets) be made available to vaccination pr oviders,
recipients, and caregivers in c ondition A will not apply if the authorized labeling (i.e.,
Fact Sheets) are made available to the regulator y authorities o f the country in which
the vaccine will be used.
Conditions With Respect t o Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individ uals
16 years of age and older. There remains, however, a significa nt amount of Pfizer-
BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with
this emergency use authorization. This aut horization thus rema ins in place with
respect to that produc t for the previously -authorized indicatio n and uses (i.e., for use
to prevent COVID-19 in individuals 12 years of age and older wi th a two-dose
regimen, and to provide a thir d dose to individ uals 12 years of age or older who have
undergone solid organ tr ansplantation, or who are diagnosed wit h conditions that are
considered to have an equivale nt level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNAT Y (COVID-19
Vaccine, mRNA) product when used to provide a two-dose regimen for individuals
aged 12 through 15 years , or to provide a thi rd dose to individuals 12 years of age or
older who have undergo ne solid organ transp lantation or who are diagnosed with
conditions that are co nsidered to have an e quivalent level of immunocompromise.
Conditions A through W in this letter apply when COMIRNATY (COV ID-19
Vaccine, mRNA) is provided for t he uses described in this subse ction III.BB, except
that product manufactured and labeled in accordance with the ap proved BLA is
deemed to satisfy th e manufacturing, labeling, and distribution requirements of this
authorization.
IV. Duration of Authorization
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This EUA will be effective until the declaration that circumsta nces exist justifying the
authorization of the emergency use of drugs and biological prod ucts during the COVID-19
pandemic is terminate d under Section 564(b)(2) of the Act or th e EUA is revoked under Section
564(g) of the Act.
Sincerely,
____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration
Enclosures
Denise M.
Hinton -SDigitally signed by Denise M. Hinton -S Date: 2021.08.23 08:36:37 -04'00'
FDA-CBER-2021-5683-0951262