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FDA Letter
FDA Letter
Pfizer Inc.
Attention: Ms. Elisa Harkins
500 Arcola Road
Collegeville, PA 19426
This letter is in response to a request from Pfizer Inc. that the Food and Drug Administration
(FDA) issue an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech
COVID‑19 Vaccine for the prevention of Coronavirus Disease 2019 (COVID-19) for individuals
16 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 February 4, 2020, pursuant to Section 564(b)(1)(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 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 terms of
any authorization issued under that section. 2
Pfizer-BioNTech COVID‑19 Vaccine is for use for active immunization to prevent COVID-19
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16
years of age and older. The vaccine contains a nucleoside-modified messenger RNA (modRNA)
encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. It is an
investigational vaccine not licensed for any indication.
FDA reviewed safety and efficacy data from an ongoing phase 1/2/3 trial in approximately
44,000 participants randomized 1:1 to receive Pfizer-BioNTech COVID‑19 Vaccine or saline
control. The trial has enrolled participants 12 years of age and older. FDA’s review has
considered the safety and effectiveness 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
1
U.S. Department of Health and Human Services, Determination of a Public Health Emergency and 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. 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).
Page 2 – Pfizer Inc.
from 37,586 of the participants 16 years of age and older, who were followed for a median of
two months after receiving the second dose, did not identify specific safety concerns that would
preclude issuance of an EUA. FDA’s analysis of the available efficacy data from 36,523
participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days
after dose 2 confirm 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 information regarding product quality and consistency, it is
reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective. Additionally,
it is reasonable to conclude, based on the totality of the scientific evidence available, that the
known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the known and
potential risks 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 voted in agreement with this conclusion.
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 of Pfizer-BioNTech COVID‑19 Vaccine for the
prevention of COVID-19, as described in the Scope of Authorization section of this letter
(Section II) and subject to the terms of this authorization.
I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the
prevention of COVID-19 when administered as described in the Scope of Authorization (Section
II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited as follows:
3
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
Page 3 – Pfizer Inc.
Product Description
Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-
modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients:
lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg
4
“Authorized Distributor(s)” are identified by Pfizer Inc. or, if applicable, by a U.S. government entity, such as the
Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to
distribute authorized Pfizer-BioNTech COVID‑19 Vaccine.
5
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, county, 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 health department is administering COVID-19 vaccines; if a pharmacy is acting in an
official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases,
it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination
providers will all be met.
6
For purposes of this letter, “vaccination provider” refers to 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 administer or provide vaccination services in accordance with the applicable emergency response
stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC
COVID-19 Vaccination Program. For purposes 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 Act Declaration for Medical
Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy
technicians and State-authorized pharmacy interns 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).
Page 4 – Pfizer Inc.
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for
“Emergency Use Authorization.” The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be
distributed, stored, further redistributed, and administered by emergency response stakeholders
when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the
fact that the vial and carton labels may not contain information that otherwise would be required
under the FD&C Act.
Pfizer-BioNTech COVID‑19 Vaccine is authorized for emergency use with the following
product-specific information required to be made available to vaccination providers and
recipients, respectively (referred to as “authorized labeling”):
• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of
Pfizer-BioNTech COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)
in Individuals 16 Years of Age and Older
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-BioNTech COVID‑19 Vaccine, when used to prevent
COVID-19 and used in accordance with this Scope of Authorization (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 that Pfizer-BioNTech COVID‑19
Vaccine may be effective in preventing COVID-19 when used in accordance 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, including the information
supporting the conclusions described in Section I above, I have concluded that Pfizer-BioNTech
COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set
forth in Section 564(c) of the Act concerning safety and potential effectiveness.
Page 5 – Pfizer Inc.
The emergency use of Pfizer-BioNTech COVID‑19 Vaccine under this EUA must be consistent
with, and may not exceed, the terms of the Authorization, including the Scope of Authorization
(Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and
under the circumstances set forth in the Secretary of HHS's determination under Section
564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section
564(b)(1), Pfizer-BioNTech COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals
16 years of age and older 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.
Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization:
A. Pfizer Inc. and authorized distributor(s) will ensure that the authorized Pfizer-
BioNTech COVID‑19 Vaccine is distributed, as directed by the U.S. government,
including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets)
will be made available to vaccination providers, recipients, and caregivers consistent
with the terms of this letter.
B. Pfizer Inc. and authorized distributor(s) will ensure that appropriate storage and cold
chain is maintained until delivered to emergency response stakeholders’ receipt sites.
C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant
stakeholders (e.g., emergency response stakeholders, authorized distributors, and
vaccination providers) involved in distributing or receiving authorized Pfizer-
BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a
copy of this letter of authorization and communicate any subsequent amendments that
might be made to this letter of authorization and its authorized labeling.
D. Pfizer Inc. may develop and disseminate instructional and educational materials (e.g.,
video regarding vaccine handling, storage/cold-chain management, preparation,
disposal) that are consistent with the authorized emergency use of the vaccine as
described in the letter of authorization and authorized labeling, without FDA’s review
and concurrence, when necessary to meet public health needs during an emergency.
Any instructional and educational materials that are inconsistent with the authorized
labeling are prohibited.
E. Pfizer Inc. may request changes to this authorization, including to the authorized Fact
Sheets for Pfizer-BioNTech COVID‑19 Vaccine, that do not alter the analysis of
benefits and risks that underlies this authorization and FDA may determine that such
changes may be permitted without amendment of this EUA. That determination must
be made by joint decision of the Office of Vaccines Research and Review
(OVRR)/Center for Biologics Evaluation and Research (CBER), the Preparedness
and Response Team (PREP)/Office of the Center Director (OD)/CBER, and the
Page 6 – Pfizer Inc.
F. Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS):
• Vaccine administration errors whether or not associated with an adverse event;
• Serious adverse events (irrespective of attribution to vaccination);
• Cases of Multisystem Inflammatory Syndrome in children and adults; and
• Cases of COVID-19 that result in hospitalization or death, that are reported to
Pfizer Inc.
These reports should be submitted to VAERS as soon as possible but no later than
15 calendar days from initial receipt of the information by Pfizer Inc.
G. Pfizer Inc. must submit to Investigational New Drug application (IND) number 19736
periodic safety reports at monthly intervals, within 15 days after the last day of a month,
beginning after the first full calendar month after authorization. Each periodic safety
report is required to contain descriptive information 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.
• Newly identified safety concerns in the interval; and
• Actions taken since the last report because of adverse experiences (for example,
changes made to Healthcare Providers Administering Vaccine (Vaccination
Providers) Fact Sheet, changes made to studies or studies initiated).
I. All manufacturing facilities will comply with Current Good Manufacturing Practice
requirements.
J. Pfizer Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug
product lot at least 48 hours prior to vaccine distribution. The CoA will include the
established specifications and specific results for each quality control test performed
on the final drug product lot.
K. Pfizer Inc. will submit to the EUA file quarterly manufacturing reports that include a
listing of all Drug Substance and Drug Product lots produced after issuance of this
authorization. This report must include lot number, manufacturing site, date of
manufacture, and lot disposition, including those lots that were quarantined for
investigation or those lots that were rejected. Information on the reasons for lot
quarantine or rejection must be included in the report. The first report is due July
2021.
Page 7 – Pfizer Inc.
L. Pfizer Inc. and authorized distributor(s) will maintain records regarding release of
Pfizer-BioNTech COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity,
release date).
M. Pfizer Inc. and authorized distributor(s) will make available to FDA upon request any
records maintained in connection with this EUA.
P. Emergency response stakeholders will ensure that vaccination providers 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 authorization, instruct
them about the means through which they are to obtain and administer the vaccine
under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for
Recipients and Caregivers] is made available to vaccination providers through
appropriate means (e.g., e-mail, website).
Vaccination Providers
S. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to
each individual receiving vaccination and provide the necessary information for
receiving their second dose.
Page 8 – Pfizer Inc.
V. Vaccination providers will monitor and comply with CDC and/or emergency
response stakeholder vaccine management requirements (e.g., requirements
concerning obtaining, tracking, and handling vaccine) and with requirements
concerning reporting of vaccine administration data to CDC.
W. Vaccination providers will ensure that any records associated with this EUA are
maintained until notified by FDA. Such records will be made available to CDC,
and FDA for inspection upon request.
X. All descriptive printed matter, advertising, and promotional material, relating to the
use of the Pfizer-BioNTech COVID‑19 Vaccine 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-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state
that:
• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 16 years of age and older; and
Page 9 – Pfizer Inc.
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization 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.
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products during the COVID-19
pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section
564(g) of the Act.
Sincerely,
--/S/--
____________________________
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration
Enclosures
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved product,
Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent
COVID-19 in individuals 16 years of age and older.
See this Fact Sheet for instructions for preparation and administration. This Fact
Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.
For information on clinical trials that are testing the use of the Pfizer-BioNTech
COVID-19 Vaccine for active immunization against COVID-19, please see
www.clinicaltrials.gov.
DESCRIPTION OF COVID-19
Revised: 12/2020 1
DOSAGE AND ADMINISTRATION
During storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light.
Undiluted vials may be stored at room temperature for no more than 2 hours.
Revised: 12/2020 2
Vials After Dilution
• After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within
6 hours from the time of dilution.
• During storage, minimize exposure to room light, and avoid exposure to
direct sunlight and ultraviolet light.
• Any vaccine remaining in vials must be discarded after 6 hours.
• Do not refreeze.
Dose Preparation
Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a
frozen suspension that does not contain preservative and must be thawed
and diluted prior to administration.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room
temperature [up to 25ºC (77ºF)] (see Storage and Handling).
• Refer to thawing instructions in the panels below.
Dilution
Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not
provided) to form the Pfizer-BioNTech COVID-19 Vaccine. ONLY use 0.9% Sodium
Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine
and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride
Injection or any other diluent.
Revised: 12/2020 3
THAWING PRIOR TO DILUTION
• Thaw vial(s) of Pfizer-BioNTech
COVID-19 Vaccine before use either
by:
o Allowing vial(s) to thaw in the
refrigerator [2ºC to 8ºC (35ºF to
46ºF)]. A carton of vials may take up
to 3 hours to thaw, and thawed vials
can be stored in the refrigerator for
up to five days (120 hours).
o Allowing vial(s) to sit at room
temperature [up to 25ºC (77ºF)] for
30 minutes.
• Using either thawing method, vials
must reach room temperature before
dilution and must be diluted within 2
hours.
• Before dilution invert vaccine vial
gently 10 times.
• Do not shake.
• Inspect the liquid in the vial prior to
dilution. The liquid is a white to off-
white suspension and may contain
white to off-white opaque amorphous
particles.
• Do not use if liquid is discolored or if
other particles are observed.
DILUTION
Revised: 12/2020 4
• Equalize vial pressure before removing
the needle from the vial by withdrawing
1.8 mL air into the empty diluent
syringe.
Revised: 12/2020 5
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH
COVID-19 VACCINE
Administration
Visually inspect each dose in the dosing syringe prior to administration. The
vaccine will be an off-white suspension. During the visual inspection,
• verify the final dosing volume of 0.3 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.
Contraindications
Warnings
Revised: 12/2020 6
Adverse Reactions
For information on clinical trials that are testing the use of the Pfizer-BioNTech
COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.
Provide a vaccination card to the recipient or their caregiver with the date when the
recipient needs to return for the second dose of Pfizer-BioNTech COVID-19
Vaccine.
Revised: 12/2020 7
MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION
In order to mitigate the risks of using this unapproved product under EUA and to
optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following
items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for
active immunization to prevent COVID-19 under this EUA is limited to the following
(all requirements must be met):
Vaccination providers may report to VAERS other adverse events that are not
required to be reported using the contact information above.
To the extent feasible, report adverse events to Pfizer Inc. using the contact
information below or by providing a copy of the VAERS form to Pfizer Inc.
ADDITIONAL INFORMATION
For general questions, visit the website or call the telephone number provided
below.
www.cvdvaccine.com
1-877-829-2619
(1-877-VAX-CO19)
AVAILABLE ALTERNATIVES
The Secretary of Health and Human Services (HHS) has declared a public health
emergency that justifies the emergency use of drugs and biological products during
the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved
product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization against
COVID-19 in individuals 16 years of age and older.
FDA issued this EUA, based on Pfizer-BioNTech’s request and submitted data.
Revised: 12/2020 9
Although limited scientific information is available, based on the totality of the
scientific evidence available to date, it is reasonable to believe that the
Pfizer-BioNTech COVID-19 Vaccine may be effective for the prevention of
COVID-19 in individuals as specified in the Full EUA Prescribing Information.
This EUA for the Pfizer-BioNTech COVID-19 Vaccine will end when the Secretary
of HHS determines that the circumstances justifying the EUA no longer exist or
when there is a change in the approval status of the product such that an EUA is
no longer needed.
For additional information about Emergency Use Authorization visit FDA at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-
and-policy-framework/emergency-use-authorization.
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1450-1.0
Revised: 12/2020 10
FULL EMERGENCY USE
AUTHORIZATION (EUA) PRESCRIBING
INFORMATION
Revised: 12/2020 11
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
1 AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for
active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a frozen suspension that does
not contain preservative and must be thawed and diluted prior to administration.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC
(77ºF)] [see How Supplied/Storage and Handling (19)].
• Refer to thawing instructions in the panels below.
Dilution
• Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not provided) to form
the Pfizer-BioNTech COVID-19 Vaccine.
• ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the
vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or
any other diluent.
• Refer to dilution and dose preparation instructions in the panels below.
Revised: 12/2020 12
THAWING PRIOR TO DILUTION
• Thaw vial(s) of Pfizer-BioNTech COVID-19
Vaccine before use either by:
o Allowing vial(s) to thaw in the refrigerator [2ºC
to 8ºC (35ºF to 46ºF)]. A carton of vials may take
up to 3 hours to thaw, and thawed vials can be
stored in the refrigerator for up to five days
(120 hours).
o Allowing vial(s) to sit at room temperature [up to
25ºC (77ºF)] for 30 minutes.
• Using either thawing method, vials must reach room
temperature before dilution and must be diluted
within 2 hours.
DILUTION
Revised: 12/2020 13
• Equalize vial pressure before removing the needle
from the vial by withdrawing 1.8 mL air into the
empty diluent syringe.
Revised: 12/2020 14
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19
VACCINE
Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white
suspension. During the visual inspection,
• verify the final dosing volume of 0.3 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL
each) three weeks apart.
There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other
COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of
Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to
complete the vaccination series.
Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.
4 CONTRAINDICATIONS
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic
reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description
(13)].
Revised: 12/2020 15
5 WARNINGS AND PRECAUTIONS
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in
the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19
Vaccine.
The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System
(VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem
Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19
following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. To the extent feasible, provide a
copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR
REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details
on reporting to VAERS and Pfizer Inc.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site
(84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%),
fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and
lymphadenopathy (0.3%).
Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass
vaccination outside of clinical trials.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 16 years of age and older in
two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America.
Study BNT162-01 (Study 1) was a Phase 1/2, two-part, dose-escalation trial that enrolled 60 participants,
18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized,
saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy
(Phase 2/3) study that has enrolled approximately 44,000 participants, 12 years of age or older. Of these,
approximately 43,448 participants (21,720 Pfizer-BioNTech COVID-19 Vaccine; 21,728 placebo) in Phase 2/3
are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and
placebo groups, respectively).
Revised: 12/2020 16
At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and
18,785 placebo) participants 16 years of age or older have been followed for a median of 2 months after the
second dose of Pfizer-BioNTech COVID-19 Vaccine.
The safety evaluation in Study 2 is ongoing. The safety population includes participants enrolled by
October 9, 2020, and includes safety data accrued through November 14, 2020. Participants 18 years and older
in the reactogenicity subset are monitored for solicited local and systemic reactions and use of antipyretic
medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited
adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all
unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination].
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity
among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo.
Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo,
50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0%
were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.
Table 1 and Table 2 present the frequency and severity of solicited local and systemic reactions, respectively,
within 7 days following each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo in the subset of
participants 18 to 55 years of age included in the EUA safety population who were monitored for reactogenicity
with an electronic diary.
Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions,
respectively, within 7 days of each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo for participants
56 years of age and older.
Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to
36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for
participants in the Pfizer-BioNTech COVID-19 Vaccine group.
Table 1: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age ‡ –
Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
N =2291
a N a =2298 N =2098
a N a=2103
n (%)
b n (%)
b n (%)
b nb (%)
Rednessc
Any (>2 cm) 104 (4.5) 26 (1.1) 123 (5.9) 14 (0.7)
Mild 70 (3.1) 16 (0.7) 73 (3.5) 8 (0.4)
Moderate 28 (1.2) 6 (0.3) 40 (1.9) 6 (0.3)
Severe 6 (0.3) 4 (0.2) 10 (0.5) 0 (0.0)
Swellingc
Any (>2 cm) 132 (5.8) 11 (0.5) 132 (6.3) 5 (0.2)
Mild 88 (3.8) 3 (0.1) 80 (3.8) 3 (0.1)
Revised: 12/2020 17
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Moderate 39 (1.7) 5 (0.2) 45 (2.1) 2 (0.1)
Severe 5 (0.2) 3 (0.1) 7 (0.3) 0 (0.0)
Pain at the injection sited
Any 1904 (83.1) 322 (14.0) 1632 (77.8) 245 (11.7)
Mild 1170 (51.1) 308 (13.4) 1039 (49.5) 225 (10.7)
Moderate 710 (31.0) 12 (0.5) 568 (27.1) 20 (1.0)
Severe 24 (1.0) 2 (0.1) 25 (1.2) 0 (0.0)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
b. n = Number of participants with the specified reaction.
c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
‡ Eight participants were between 16 and 17 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age ‡ –
Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Fever
≥38.0℃ 85 (3.7) 20 (0.9) 331 (15.8) 10 (0.5)
≥38.0℃ to 38.4℃ 64 (2.8) 10 (0.4) 194 (9.2) 5 (0.2)
>38.4℃ to 38.9℃ 15 (0.7) 5 (0.2) 110 (5.2) 3 (0.1)
>38.9℃ to 40.0℃ 6 (0.3) 3 (0.1) 26 (1.2) 2 (0.1)
>40.0℃ 0 (0.0) 2 (0.1) 1 (0.0) 0 (0.0)
Fatigue c
Revised: 12/2020 18
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Vomitingd
Any 28 (1.2) 28 (1.2) 40 (1.9) 25 (1.2)
Mild 24 (1.0) 22 (1.0) 28 (1.3) 16 (0.8)
Moderate 4 (0.2) 5 (0.2) 8 (0.4) 9 (0.4)
Severe 0 (0.0) 1 (0.0) 4 (0.2) 0 (0.0)
Diarrheae
Any 255 (11.1) 270 (11.7) 219 (10.4) 177 (8.4)
Mild 206 (9.0) 217 (9.4) 179 (8.5) 144 (6.8)
Moderate 46 (2.0) 52 (2.3) 36 (1.7) 32 (1.5)
Severe 3 (0.1) 1 (0.0) 4 (0.2) 1 (0.0)
New or worsened
muscle painc
Any 487 (21.3) 249 (10.8) 783 (37.3) 173 (8.2)
Mild 256 (11.2) 175 (7.6) 326 (15.5) 111 (5.3)
Moderate 218 (9.5) 72 (3.1) 410 (19.5) 59 (2.8)
Severe 13 (0.6) 2 (0.1) 47 (2.2) 3 (0.1)
New or worsened
joint painc
Any 251 (11.0) 138 (6.0) 459 (21.9) 109 (5.2)
Mild 147 (6.4) 95 (4.1) 205 (9.8) 54 (2.6)
Moderate 99 (4.3) 43 (1.9) 234 (11.2) 51 (2.4)
Severe 5 (0.2) 0 (0.0) 20 (1.0) 4 (0.2)
Use of antipyretic or
pain medicationf 638 (27.8) 332 (14.4) 945 (45.0) 266 (12.6)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after
each dose.
a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
b. n = Number of participants with the specified reaction.
c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
f. Severity was not collected for use of antipyretic or pain medication.
‡ Eight participants were between 16 and 17 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Revised: 12/2020 19
Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1802 Na=1792 Na=1660 Na=1646
nb (%) nb (%) nb (%) nb (%)
Redness c
Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech
Pfizer-BioNTech COVID-19
COVID-19 Vaccine Placebo Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1802 Na=1792 Na=1660 Na=1646
nb (%) nb (%) nb (%) nb (%)
Fever
≥38.0℃ 26 (1.4) 7 (0.4) 181 (10.9) 4 (0.2)
≥38.0℃ to 38.4℃ 23 (1.3) 2 (0.1) 131 (7.9) 2 (0.1)
>38.4℃ to 38.9℃ 1 (0.1) 3 (0.2) 45 (2.7) 1 (0.1)
>38.9℃ to 40.0℃ 1 (0.1) 2 (0.1) 5 (0.3) 1 (0.1)
>40.0℃ 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
Fatigue c
Revised: 12/2020 21
Unsolicited Adverse Events
In Study 2, among participants 16 to 55 years of age who had received at least 1 dose of vaccine or placebo
(Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1
through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19
Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, in participants 56 years of age and
older (Pfizer-BioNTech COVID-19 Vaccine = 7960, placebo = 7934), serious adverse events were reported by
0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at
least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses, 91.6% of study
participants had at least 30 days of follow-up after Dose 2. Appendicitis was reported as a serious adverse event
for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo
participants. Currently available information is insufficient to determine a causal relationship with the vaccine.
There were no other notable patterns or numerical imbalances between treatment groups for specific categories
of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest
a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.
Overall in Study 2 in which 10,841 participants 16 to 55 years of age received Pfizer-BioNTech COVID-19
Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to
30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received
Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who
received at least 1 dose. Overall in a similar analysis in which 7960 participants 56 years of age and older
received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in
23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the
placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had
at least 30 days of follow-up after Dose 2. The higher frequency of reported unsolicited non-serious adverse
events among Pfizer BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily
attributed to local and systemic adverse events reported during the first 7 days following vaccination that are
consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in
Tables 3 and 4. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with
notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is
plausibly related to vaccination. Throughout the safety follow-up period to date, Bell’s palsy (facial paralysis)
was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis
was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of
Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a
causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between
treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-
inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19
Vaccine.
The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for
MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine
Adverse Event Reporting System (VAERS):
Revised: 12/2020 22
• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events* (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults
• Cases of COVID-19 that result in hospitalization or death
The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a
VAERS form to FDA using one of the following methods:
• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If
you need additional help submitting a report you may call the VAERS toll-free information line at
1-800-822-7967 or send an email to [email protected].
IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please
complete the entire form with detailed information. It is important that the information reported to FDA
be as detailed and complete as possible. Information to include:
• Patient demographics (e.g., patient name, date of birth)
• Pertinent medical history
• Pertinent details regarding admission and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19
Vaccine
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the time of the
VAERS report. Subsequent reporting of follow-up information should be completed if additional
details become available.
The following steps are highlighted to provide the necessary information for safety tracking:
1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines
administered on the same day; and in Box 22, provide information on any other vaccines received within
one month prior.
2. In Box 18, description of the event:
a. Write “Pfizer-BioNTech COVID-19 Vaccine EUA” as the first line.
b. Provide a detailed report of vaccine administration error and/or adverse event. It is important to
provide detailed information regarding the patient and adverse event/medication error for
ongoing safety evaluation of this unapproved vaccine. Please see information to include listed
above.
Revised: 12/2020 23
3. Contact information:
a. In Box 13, provide the name and contact information of the prescribing healthcare provider or
institutional designee who is responsible for the report.
b. In Box 14, provide the name and contact information of the best doctor/healthcare professional
to contact about the adverse event.
c. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare
provider’s office address).
Vaccination providers may report to VAERS other adverse events that are not required to be reported using the
contact information above.
To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a
copy of the VAERS form to Pfizer Inc.
10 DRUG INTERACTIONS
There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with
other vaccines.
11.1 Pregnancy
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the
estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to
4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to
pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
11.2 Lactation
Risk Summary
Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on
milk production/excretion.
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 16 and 17 years of age is
based on extrapolation of safety and effectiveness from adults 18 years of age and older. Emergency Use
Authorization of Pfizer BioNTech COVID-19 Vaccine does not include use in individuals younger than
16 years of age.
Revised: 12/2020 24
11.4 Geriatric Use
Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their
data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical
Trial Results and Supporting Data for EUA (18.1)]. Of the total number of Pfizer-BioNTech COVID-19
Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860)
were 75 years of age and older.
13 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 Injection, USP prior to use to form the vaccine.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger
RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg
(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-
N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol),
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, USP)
contributes an additional 2.16 mg sodium chloride per dose.
The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with
natural rubber latex.
14 CLINICAL PHARMACOLOGY
The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable
delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an
immune response to the S antigen, which protects against COVID-19.
In the Phase 2/3 portion approximately 44,000 participants 12 years of age and older were randomized equally
and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine or placebo separated by 21 days. Participants are
planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.
Revised: 12/2020 25
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age
and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did
not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Table 5 presents
the specific demographic characteristics in the studied population.
Revised: 12/2020 26
Efficacy Against COVID-19
The population in the primary efficacy analysis included all participants 12 years of age and older who had been
enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020.
Participants 18 to 55 years of age and 56 years of age and older began enrollment from July 27,2020, 16 to
17 years of age began enrollment from September 16, 2020 and 12 to 15 years of age began enrollment from
October 15, 2020.
Table 6: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age
Subgroup – Participants Without Evidence of Infection and Participants With or Without
Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior
SARS-CoV-2 infection*
Pfizer-BioNTech Placebo
COVID-19 Vaccine
Na=18,198 Na=18,325
Cases Cases
n1 b n1 b Vaccine Efficacy %
Subgroup Surveillance Time (n2 ) Surveillance Time c (n2 d)
c d (95% CI)
All subjects e 8 162 95.0 (90.3, 97.6)f
2.214 (17,411) 2.222 (17,511)
16 to 64 years 7 143 95.1 (89.6, 98.1)g
1.706 (13,549) 1.710 (13,618)
65 years and older 1 19 94.7 (66.7, 99.9)g
0.508 (3848) 0.511 (3880)
First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior
SARS-CoV-2 infection
Pfizer-BioNTech Placebo
COVID-19 Vaccine
Na=19,965 Na=20,172
Cases Cases
n1 b n1 b Vaccine Efficacy %
Subgroup Surveillance Time (n2 ) Surveillance Time c (n2 d)
c d (95% CI)
All subjects e 9 169 94.6 (89.9, 97.3)f
2.332 (18,559) 2.345 (18,708)
16 to 64 years 8 150 94.6 (89.1, 97.7)g
1.802 (14,501) 1.814 (14,627)
65 years and older 1 19 94.7 (66.8, 99.9)g
0.530 (4044) 0.532 (4067)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled
visit prior to 7 days after Dose 2 were included in the analysis.
a. N = number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the
endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Revised: 12/2020 27
d. n2 = Number of participants at risk for the endpoint.
e. No confirmed cases were identified in participants 12 to 15 years of age.
f. Credible interval for VE was calculated using a beta-binomial model with a beta (0.700102, 1) prior for θ=r(1-VE)/(1+r(1-VE)),
where r is the ratio of surveillance time in the active vaccine group over that in the placebo group.
g. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance
time.
Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied
in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials
(NDC 59267-1000-2).
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice.
Once received, remove the vial cartons immediately from the thermal container and store in an ultra-low
temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). Vials must be kept frozen between -80ºC
to -60ºC (-112ºF to -76ºF) and protected from light, in the original cartons, until ready to use.
If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech
COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the
container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions
regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature
range of -90ºC to -60ºC (-130ºF to -76ºF). Storage within this temperature range is not considered an excursion
from the recommended storage condition.
Undiluted vials may be stored at room temperature for no more than 2 hours.
Revised: 12/2020 28
Vials After Dilution
After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Any vaccine remaining in vials must be discarded after 6 hours. Do not refreeze.
Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.
The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization
Information System (IIS) or other designated system. Advise recipient or caregiver that more information about
IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.
21 CONTACT INFORMATION
For general questions, visit the website or call the telephone number provided below.
1-877-829-2619
(1-877-VAX-CO19)
This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing
Information, please see www.cvdvaccine.com.
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1457-1.0
Revised: 12/2020 29
FACT SHEET FOR RECIPIENTS AND CAREGIVERS
You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus
Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains
information to help you understand the risks and benefits of the Pfizer-BioNTech
COVID-19 Vaccine, which you may receive because there is currently a pandemic of
COVID-19.
The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to
prevent COVID-19.
Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine.
Talk to the vaccination provider if you have questions. It is your choice to receive the
Pfizer-BioNTech COVID-19 Vaccine.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.
WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of
coronavirus has not been seen before. You can get COVID-19 through contact with
another person who has the virus. It is predominantly a respiratory illness that can
affect other organs. People with COVID-19 have had a wide range of symptoms
reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to
14 days after exposure to the virus. Symptoms may include: fever or chills; cough;
shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
For more information on EUA, see the “What is an Emergency Use Authorization
(EUA)?” section at the end of this Fact Sheet.
If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive
a second dose of this same vaccine 3 weeks later to complete the vaccination series.
There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a
severe allergic reaction. A severe allergic reaction would usually occur within a few
minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine.
Signs of a severe allergic reaction can include:
• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness
These may not be all the possible side effects of the Pfizer-BioNTech COVID-19
Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19
Vaccine is still being studied in clinical trials.
Call the vaccination provider or your healthcare provider if you have any side effects
that bother you or do not go away.
In addition, you can report side effects to Pfizer Inc. at the contact information provided
below.
To access the most recent Fact Sheets, please scan the QR code provided below.
The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as
an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are
met, which includes that there are no adequate, approved, available alternatives. In
addition, the FDA decision is based on the totality of scientific evidence available
showing that the product may be effective to prevent COVID-19 during the COVID-19
5 Revised: December 2020
pandemic and that the known and potential benefits of the product outweigh the known
and potential risks of the product. All of these criteria must be met to allow for the
product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the
COVID-19 EUA declaration justifying emergency use of these products, unless
terminated or revoked (after which the products may no longer be used).
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1451-0.7