FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF
THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
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 12 years of age and older.
SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must
report all vaccine administration errors, all serious adverse events, cases ofMultisystem Inflammatory Syndrome (MIS) in adults and children, and cases of
COVID-19 that result in hospitalization or death following administration of
Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FORPFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER
EMERGENCY USE AUTHORIZATION” for reporting requirements.
The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection
administered as a series of two doses (0.3 mL each) 3 weeks apart.
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
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by thenovel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a
respiratory illness that can affect other organs. People with COVID-19 havereported a wide range of symptoms, 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.

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DOSAGE AND ADMINISTRATION
Storage and Handling
During storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light.
Do not refreeze thawed vials.
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive inthermal containers with dry ice. Once received, remove the vial cartons
immediately from the thermal container and preferably store in an ultra-low
temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF) until the expiry dateprinted on the label. Alternatively, vials may be stored at -25°C to -15°C (-13°F to5°F) for up to 2 weeks. Vials must be kept frozen and protected from light until
ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may
be returned one time to the recommended storage condition of -80ºC to -60ºC(-112ºF to -76ºF). Total cumulative time the vials are stored at -25°C to -15°C(-13°F to 5°F) should be tracked and should not exceed 2 weeks.
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 there-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 of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an
excursion from the recommended storage condition.
Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot betransported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C
to -15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F).
Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one timeto the recommended storage condition of -80ºC to -60ºC (-112ºF to -76ºF).
Thawed Vials Before Dilution
Thawed Under Refrigeration
Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]
for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours,
respectively, to thaw in the refrigerator, whereas a fewer number of vials will thawin less time.
Revised: 19 May 20212

Thawed at Room Temperature
For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for
30 minutes. Thawed vials can be handled in room light conditions. Vials must reachroom temperature before dilution.
Undiluted vials may be stored at room temperature for no more than 2 hours.
Transportation of Thawed Vials
Available data support transportation of one or more thawed vials at 2°C to 8°C(35°F to 46°F) for up to 12 hours.
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 todirect sunlight and ultraviolet light.
Any vaccine remaining in vials must be discarded after 6 hours.
Do not refreeze.

Dosing and Schedule
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as aseries of two doses (0.3 mL each) 3 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 tocomplete the vaccination series.
Dose Preparation
Prior to Dilution• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a
volume of 0.45 mL, supplied as a frozen suspension that does not containpreservative. Each vial 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 (notprovided) 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
Revised: 19 May 2021

3

and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride
Injection or any other diluent. Do not add more than 1.8 mL of diluent.
After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may
state that after dilution, a vial contains 5 doses of 0.3 mL. The information in thisFact Sheet regarding the number of doses per vial after dilution supersedes thenumber of doses stated on vial labels and cartons.
•

Refer to dilution and dose preparation instructions in the panels below.

THAWING PRIOR TO DILUTION
Thaw vial(s) of Pfizer-BioNTech
COVID-19 Vaccine before use eitherby:o Allowing vial(s) to thaw in the
refrigerator [2ºC to 8ºC (35ºF to46ºF)]. A carton of vials may take up
to 3 hours to thaw, and thawed vials
can be stored in the refrigerator for
up to 1 month.
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.
•

•
•
•

•

Revised: 19 May 2021

Before dilution invert vaccine vial
gently 10 times.
Do not shake.
Inspect the liquid in the vial prior todilution. The liquid is a white to offwhite suspension and may containwhite to off-white opaque amorphous
particles.
Do not use if liquid is discolored or if
other particles are observed.

4

DILUTION
•
•
•
•

•

Equalize vial pressure before removing
the needle from the vial by withdrawing
1.8 mL air into the empty diluent
syringe.

•

Gently invert the vial containing thePfizer-BioNTech COVID-19 Vaccine
10 times to mix.
Do not shake.
Inspect the vaccine in the vial.
The vaccine will be an off-whitesuspension. Do not use if vaccine is
discolored or contains particulatematter.

•••Revised: 19 May 2021

Obtain sterile 0.9% Sodium Chloride
Injection, USP. Use only this as thediluent.
Using aseptic technique, withdraw
1.8 mL of diluent into a transfer syringe(21-gauge or narrower needle).
Cleanse the vaccine vial stopper with asingle-use antiseptic swab.
Add 1.8 mL of 0.9% Sodium Chloride
Injection, USP into the vaccine vial.

5

•
•
•

Record the date and time of dilution on
the Pfizer-BioNTech COVID-19
Vaccine vial label.
Store between 2°C to 25°C (35°F to77°F).
Discard any unused vaccine 6 hours
after dilution.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH
COVID-19 VACCINE
•

•
•

•

Using aseptic technique, cleanse thevial stopper with a single-use antiseptic
swab, and withdraw 0.3 mL of the
Pfizer-BioNTech COVID-19 Vaccine
preferentially using a low dead-volume
syringe and/or needle.
Each dose must contain 0.3 mL ofvaccine.
If the amount of vaccine remaining in
the vial cannot provide a full dose of
0.3 mL, discard the vial and any
excess volume.
Administer immediately.

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.
Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.
After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of
0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to
extract six doses from a single vial. If standard syringes and needles are used,
there may not be sufficient volume to extract a sixth dose from a single vial.
Irrespective of the type of syringe and needle:

Revised: 19 May 2021

6

•
•
•

Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of
0.3 mL, discard the vial and content.
Do not pool excess vaccine from multiple vials.

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 Full EUA Prescribing Information).
Warnings
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.
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence ofimmediate adverse reactions according to the Centers for Disease Control andPrevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/managing-anaphylaxis.html).
Syncope (fainting) may occur in association with administration of injectablevaccines, in particular in adolescents. Procedures should be in place to avoid injury
from fainting.
Immunocompromised persons, including individuals receiving immunosuppressanttherapy, may have a diminished immune response to the Pfizer-BioNTech
COVID-19 Vaccine.
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Adverse Reactions
Adverse Reactions in Clinical Trials
Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that havebeen reported in clinical trials include injection site pain, fatigue, headache, muscle
pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea,
malaise, and lymphadenopathy (see Full EUA Prescribing Information).
Adverse Reactions in Post Authorization Experience
Severe allergic reactions, including anaphylaxis, and other hypersensitivity
reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, and pain in
extremity (arm) have been reported following administration of the Pfizer-BioNTech
COVID-19 Vaccine outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become
apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
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7

Use with Other Vaccines
There is no information on the co-administration of the Pfizer-BioNTech COVID-19
Vaccine with other vaccines.
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or theircaregiver, information consistent with the “Fact Sheet for Recipients andCaregivers” (and provide a copy or direct the individual to the website
www.cvdvaccine.com to obtain the Fact Sheet) prior to the individual receiving
each dose of Pfizer-BioNTech COVID-19 Vaccine, including:• FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19
Vaccine, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse
Pfizer-BioNTech COVID-19 Vaccine.
• The significant known and potential risks and benefits of Pfizer-BioNTech
COVID-19 Vaccine, and the extent to which such risks and benefits are
unknown.
• Information about available alternative vaccines and the risks and benefits of
those alternatives.
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 therecipient needs to return for the second dose of Pfizer-BioNTech COVID-19
Vaccine.
Provide the v-safe information sheet to vaccine recipients/caregivers andencourage vaccine recipients to participate in v-safe. V-safe is a new voluntarysmartphone-based tool that uses text messaging and web surveys to check in withpeople who have been vaccinated to identify potential side effects after COVID-19
vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19
vaccines. V-safe also provides second-dose reminders if needed and live
telephone follow-up by CDC if participants report a significant health impact
following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.
MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINEADMINISTRATION 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 foractive immunization to prevent COVID-19 under this EUA is limited to the following(all requirements must be met):
Revised: 19 May 2021

8

1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals
12 years of age and older.
2. The vaccination provider must communicate to the individual receiving thePfizer-BioNTech COVID-19 Vaccine or their caregiver, informationconsistent with the “Fact Sheet for Recipients and Caregivers” prior to theindividual receiving Pfizer-BioNTech COVID-19 Vaccine.
3. The vaccination provider must include vaccination information in thestate/local jurisdiction’s Immunization Information System (IIS) or otherdesignated system.
4. The vaccination provider is responsible for mandatory reporting of thefollowing to the Vaccine Adverse Event Reporting System (VAERS):• vaccine administration errors whether or not associated with anadverse event,• serious adverse events* (irrespective of attribution to vaccination),• cases of Multisystem Inflammatory Syndrome (MIS) in adults andchildren, and• cases of COVID-19 that result in hospitalization or death.
Complete and submit reports to VAERS online athttps://vaers.hhs.gov/reportevent.html. For further assistance with reporting
to VAERS call 1-800-822-7967. The reports should include the words“Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of thereport.
5. The vaccination provider is responsible for responding to FDA requests for
information about vaccine administration errors, adverse events, cases of
MIS in adults and children, and cases of COVID-19 that result in
hospitalization or death following administration of Pfizer-BioNTech
COVID-19 Vaccine to recipients.
* Serious adverse events are defined as:• Death;• A life-threatening adverse event;• Inpatient hospitalization or prolongation of existing hospitalization;• A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;• A congenital anomaly/birth defect;• An important medical event that based on appropriate medical judgement
may jeopardize the individual and may require medical or surgicalintervention to prevent one of the outcomes listed above.

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9

OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC.
Vaccination providers may report to VAERS other adverse events that are notrequired 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.
WebsiteFax number

Telephone number

www.pfizersafetyreporting.com

1-866-635-8337

1-800-438-1985

ADDITIONAL INFORMATION
For general questions, visit the website or call the telephone number provided
below.
To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets,
please scan the QR code provided below.
Global website

Telephone number

www.cvdvaccine.com
1-877-829-2619(1-877-VAX-CO19)

AVAILABLE ALTERNATIVES
There is no approved alternative vaccine to prevent COVID-19. There may beclinical trials or availability under EUA of other COVID-19 vaccines.
FEDERAL COVID-19 VACCINATION PROGRAM
This vaccine is being made available for emergency use exclusively through the
CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare
providers must enroll as providers in the Vaccination Program and comply with theprovider requirements. Vaccination providers may not charge any fee for thevaccine and may not charge the vaccine recipient any out-of-pocket charge foradministration. However, vaccination providers may seek appropriate
reimbursement from a program or plan that covers COVID-19 vaccine
administration fees for the vaccine recipient (private insurance, Medicare,
Medicaid, Health Resources & Services Administration [HRSA] COVID-19
Uninsured Program for non-insured recipients). For information regarding provider
requirements and enrollment in the CDC COVID-19 Vaccination Program, see
https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.
Revised: 19 May 2021

10

Individuals becoming aware of any potential violations of the CDC COVID-19
Vaccination Program requirements are encouraged to report them to the Office of
the Inspector General, U.S. Department of Health and Human Services, at
1-800-HHS-TIPS or https://TIPS.HHS.GOV.
AUTHORITY FOR ISSUANCE OF THE EUAThe Secretary of Health and Human Services (HHS) has declared a public healthemergency 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 12 years of age and older.
FDA issued this EUA, based on Pfizer-BioNTech’s request and submitted data.
Although limited scientific information is available, based on the totality of thescientific 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 Secretaryof 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-regulatoryand-policy-framework/emergency-use-authorization.
The Countermeasures Injury Compensation Program
The Countermeasures Injury Compensation Program (CICP) is a federal programthat has been created to help pay for related costs of medical care and otherspecific expenses to compensate people injured after use of certain medical
countermeasures. Medical countermeasures are specific vaccines, medications,devices, or other items used to prevent, diagnose, or treat the public during a publichealth emergency or a security threat. For more information about CICP regarding
the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit
www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.

Manufactured by
Pfizer Inc., New York, NY 10017
Revised: 19 May 2021

11

Manufactured for
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany
LAB-1450-8.2b
Revised: 19 May 2021
END SHORT VERSION FACT SHEETLong Version (Full EUA Prescribing Information) Begins On Next Page

Revised: 19 May 2021

12

FULL EMERGENCY USEAUTHORIZATION (EUA) PRESCRIBING
INFORMATIONPFIZER-BIONTECH COVID-19 VACCINE
8FULL EMERGENCY USE AUTHORIZATIONPRESCRIBING INFORMATION: CONTENTS*
1
2

3
4
5

6

AUTHORIZED USE
DOSAGE AND ADMINISTRATION
2.1
Preparation for Administration
2.2
Administration Information
2.3
Vaccination Schedule for Individuals 12 Years of Age and Older
DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSWARNINGS AND PRECAUTIONS
5.1
Management of Acute Allergic Reactions
5.2
Syncope
5.3
Altered Immunocompetence
5.4
Limitation of Effectiveness
OVERALL SAFETY SUMMARY
6.1
Clinical Trials Experience
6.2
Post Authorization Experience

REQUIREMENTS AND INSTRUCTIONS FOR REPORTING
ADVERSE EVENTS AND VACCINE ADMINISTRATIONERRORS
10 DRUG INTERACTIONS
11 USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
11.2 Lactation
11.3 Pediatric Use
11.4 Geriatric Use
13 DESCRIPTION
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR
EUA
18.1 Efficacy in Participants 16 Years of Age and Older
18.2 Efficacy in Adolescents 12 Through 15 Years of Age
18.3 Immunogenicity in Adolescents 12 Through 15 Years of Age
19 HOW SUPPLIED/STORAGE AND HANDLING
20 PATIENT COUNSELING INFORMATION
21 CONTACT INFORMATION* Sections or subsections omitted from the full emergency use authorizationprescribing information are not listed.

Revised: 19 May 2021

13

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION1AUTHORIZED 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 12 years of age and older.
2

DOSAGE AND ADMINISTRATION

For intramuscular injection only.
2.1

Preparation for Administration

Prior to Dilution•••

The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a volume of 0.45 mL, supplied
as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior toadministration.
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. Do not add more than 1.8 mL of diluent.
ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with thevaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or
any other diluent.
After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution,a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information regarding
the number of doses per vial after dilution supersedes the number of doses stated on vial labels andcartons.
Refer to dilution and dose preparation instructions in the panels below.

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14

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 takeup to 3 hours to thaw, and thawed vials can be
stored in the refrigerator for up to 1 month.
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: 19 May 2021

Obtain sterile 0.9% Sodium Chloride Injection,
USP. Use only this as the diluent.
Using aseptic technique, withdraw 1.8 mL of diluent
into a transfer syringe (21-gauge or narrower
needle).
Cleanse the vaccine vial stopper with a single-use
antiseptic swab.
Add 1.8 mL of 0.9% Sodium Chloride Injection,
USP into the vaccine vial.

15•

Equalize vial pressure before removing the needle
from the vial by withdrawing 1.8 mL air into theempty diluent syringe.

•

Gently invert the vial containing thePfizer-BioNTech COVID-19 Vaccine 10 times tomix.
Do not shake.
Inspect the vaccine in the vial.
The vaccine will be an off-white suspension. Do notuse if vaccine is discolored or contains particulatematter.

•
•

•

•
•
•

Revised: 19 May 2021

Record the date and time of dilution on the
Pfizer-BioNTech COVID-19 Vaccine vial label.
Store between 2°C to 25°C (35°F to 77°F).
Discard any unused vaccine 6 hours after dilution.

16

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19
VACCINE
•

•
•
•
2.2

Using aseptic technique, cleanse the vial stopperwith a single-use antiseptic swab, and withdraw
0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine
preferentially using low dead-volume syringes
and/or needles.
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vialcannot provide a full dose of 0.3 mL, discard thevial and any excess volume.
Administer immediately.

Administration Information

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-whitesuspension. 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.
Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.
After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low
dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes
and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespectiveof the type of syringe and needle:• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial andany excess volume.
• Do not pool excess vaccine from multiple vials.
2.3

Vaccination Schedule for Individuals 12 Years of Age and Older

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mLeach) 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 tocomplete the vaccination series.
3

DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.

Revised: 19 May 2021

17

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)].
5

WARNINGS AND PRECAUTIONS

5.1

Management of Acute Allergic Reactions

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.
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions
according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid19/clinical-considerations/managing-anaphylaxis.html).
5.2

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, in particular inadolescents. Procedures should be in place to avoid injury from fainting.
5.3

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have adiminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
5.4

Limitation of Effectiveness

The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
6

OVERALL SAFETY SUMMARY

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 FORREPORTING 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%), andlymphadenopathy (0.3%).
In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site
(90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain
(20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea(0.4%).
Revised: 19 May 2021

18

Severe allergic reactions, including anaphylaxis, have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
6.1

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.
The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 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 46,000 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 andplacebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in thevaccine and placebo groups, respectively).
In Study 2, all participants 12 to <16 years of age, and participants 16 years of age and older in thereactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic
medication after each vaccination in an electronic diary. Participants are being monitored for unsolicitedadverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (allunsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Tables 1 through 6
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.
Participants 16 Years of Age and Older
At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and18,785 placebo) participants 16 years of age or older had been followed for a median of 2 months after thesecond dose of Pfizer-BioNTech COVID-19 Vaccine.
The safety evaluation in Study 2 is ongoing. The safety population includes participants 16 years and older
enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020.
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.
Solicited Local and Systemic Adverse Reactions
Across both age groups, 18 through 55 years of age and 56 years and older, 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 forswelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group.
Solicited reactogenicity data in 16 and 17 year-old participants are limited.
Revised: 19 May 2021

19

Table 1: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 18 Through 55 Years ofAge‡ – 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 2aaaN =2291
N =2098
N =2298
Na=2103
b
b
b
n (%)
n (%)
n (%)
nb (%)c
RednessAny (>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)Severe6 (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)Moderate
39 (1.7)
5 (0.2)45 (2.1)
2 (0.1)
Severe5 (0.2)3 (0.1)7 (0.3)0 (0.0)Pain at the injection sitedAny
1904 (83.1)
322 (14.0)
1632 (77.8)
245 (11.7)
Mild1170 (51.1)
308 (13.4)
1039 (49.5)
225 (10.7)
Moderate
710 (31.0)
12 (0.5)568 (27.1)
20 (1.0)
Severe24 (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 Through 55 Years ofAge‡ – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech
Pfizer-BioNTech
COVID-19 Vaccine
Placebo
COVID-19 Vaccine
Placebo
Dose 1
Dose 2
Dose 1
Dose 2aaaN =2291
N =2298
N =2098
Na=2103
b
b
b
n (%)
n (%)
n (%)
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)FatiguecAny1085 (47.4)
767 (33.4)
1247 (59.4)
479 (22.8)
Mild
597 (26.1)
467 (20.3)
442 (21.1)
248 (11.8)
Moderate
455 (19.9)
289 (12.6)
708 (33.7)
217 (10.3)
Severe33 (1.4)
11 (0.5)
97 (4.6)
14 (0.7)
Revised: 19 May 2021

20

Headachec
Any
Mild
Moderate
Severec
ChillsAny
Mild
Moderate
SevereVomitingd
Any
Mild
Moderate
SevereDiarrheae
Any
Mild
Moderate
SevereNew or worsened
muscle painc
Any
Mild
Moderate
SevereNew or worsened
joint painc
Any
Mild
Moderate
SevereUse of antipyretic or
pain medicationf

Pfizer-BioNTech
COVID-19 Vaccine
Dose 1
Na=2291nb (%)

Placebo
Dose 1
Na=2298
nb (%)

Pfizer-BioNTech
COVID-19 Vaccine
Dose 2
Na=2098
nb (%)

Placebo
Dose 2
Na=2103nb (%)

959 (41.9)
628 (27.4)
308 (13.4)
23 (1.0)775 (33.7)
505 (22.0)
251 (10.9)
19 (0.8)1085 (51.7)
538 (25.6)
480 (22.9)
67 (3.2)

506 (24.1)
321 (15.3)
170 (8.1)
15 (0.7)

321 (14.0)
230 (10.0)
82 (3.6)
9 (0.4)146 (6.4)
111 (4.8)
33 (1.4)
2 (0.1)737 (35.1)
359 (17.1)
333 (15.9)
45 (2.1)

79 (3.8)
65 (3.1)
14 (0.7)
0 (0.0)28 (1.2)
24 (1.0)
4 (0.2)0 (0.0)28 (1.2)
22 (1.0)5 (0.2)1 (0.0)40 (1.9)28 (1.3)
8 (0.4)4 (0.2)25 (1.2)
16 (0.8)
9 (0.4)0 (0.0)255 (11.1)
206 (9.0)
46 (2.0)
3 (0.1)270 (11.7)
217 (9.4)
52 (2.3)
1 (0.0)219 (10.4)
179 (8.5)
36 (1.7)
4 (0.2)177 (8.4)
144 (6.8)
32 (1.5)
1 (0.0)487 (21.3)
256 (11.2)
218 (9.5)
13 (0.6)

249 (10.8)
175 (7.6)
72 (3.1)
2 (0.1)783 (37.3)
326 (15.5)
410 (19.5)
47 (2.2)

173 (8.2)
111 (5.3)
59 (2.8)
3 (0.1)251 (11.0)
147 (6.4)
99 (4.3)
5 (0.2)138 (6.0)
95 (4.1)
43 (1.9)
0 (0.0)459 (21.9)
205 (9.8)
234 (11.2)
20 (1.0)109 (5.2)
54 (2.6)
51 (2.4)
4 (0.2)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: 19 May 2021

21

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 andOlder – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech
Pfizer-BioNTech
COVID-19 Vaccine
Placebo
COVID-19 Vaccine
Placebo
Dose 1
Dose 2
Dose 1
Dose 2
Na=1802
Na=1792
Na=1660
Na=1646nb (%)
nb (%)
nb (%)
nb (%)c
RednessAny (>2 cm)
85 (4.7)
19 (1.1)
120 (7.2)
12 (0.7)
Mild
55 (3.1)
12 (0.7)
59 (3.6)
8 (0.5)Moderate
27 (1.5)5 (0.3)53 (3.2)
3 (0.2)
Severe3 (0.2)2 (0.1)8 (0.5)1 (0.1)c
Swelling
Any (>2 cm)
118 (6.5)
21 (1.2)
124 (7.5)
11 (0.7)
Mild
71 (3.9)
10 (0.6)
68 (4.1)
5 (0.3)Moderate
45 (2.5)
11 (0.6)
53 (3.2)
5 (0.3)Severe2 (0.1)0 (0.0)3 (0.2)1 (0.1)Pain at the injectionsitedAny (>2 cm)
1282 (71.1)
166 (9.3)
1098 (66.1)
127 (7.7)
Mild1008 (55.9)
160 (8.9)792 (47.7)
125 (7.6)
Moderate
270 (15.0)
6 (0.3)298 (18.0)
2 (0.1)
Severe4 (0.2)0 (0.0)8 (0.5)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.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

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 andOlder – 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 2aaa
N =1792
Na=1646
N =1802
N =1660
b
b
b
n (%)
n (%)
n (%)
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)FatiguecAny
615 (34.1)
405 (22.6)
839 (50.5)
277 (16.8)
Mild
373 (20.7)
252 (14.1)
351 (21.1)
161 (9.8)
Moderate
240 (13.3)
150 (8.4)
442 (26.6)
114 (6.9)
Severe2 (0.1)3 (0.2)46 (2.8)
2 (0.1)
Revised: 19 May 2021

22

Headachec
Any
Mild
Moderate
Severec
ChillsAny
Mild
Moderate
SevereVomitingd
Any
Mild
Moderate
SevereDiarrheae
Any
Mild
Moderate
SevereNew or worsened
muscle painc
Any
Mild
Moderate
SevereNew or worsened joint
painc
Any
Mild
Moderate
SevereUse of antipyretic or
pain medication

Pfizer-BioNTech
COVID-19 Vaccine
Dose 1
Na=1802nb (%)

Placebo
Dose 1
Na=1792nb (%)

Pfizer-BioNTech
COVID-19 Vaccine
Dose 2
Na=1660
nb (%)

Placebo
Dose 2
Na=1646nb (%)

454 (25.2)
348 (19.3)
104 (5.8)
2 (0.1)325 (18.1)
242 (13.5)
80 (4.5)
3 (0.2)647 (39.0)
422 (25.4)
216 (13.0)
9 (0.5)229 (13.9)
165 (10.0)
60 (3.6)
4 (0.2)113 (6.3)
87 (4.8)
26 (1.4)
0 (0.0)57 (3.2)
40 (2.2)
16 (0.9)
1 (0.1)377 (22.7)
199 (12.0)
161 (9.7)
17 (1.0)46 (2.8)35 (2.1)
11 (0.7)
0 (0.0)9 (0.5)8 (0.4)1 (0.1)0 (0.0)9 (0.5)9 (0.5)0 (0.0)0 (0.0)11 (0.7)
9 (0.5)1 (0.1)1 (0.1)5 (0.3)5 (0.3)0 (0.0)0 (0.0)147 (8.2)
118 (6.5)
26 (1.4)
3 (0.2)118 (6.6)
100 (5.6)
17 (0.9)
1 (0.1)137 (8.3)
114 (6.9)
21 (1.3)
2 (0.1)99 (6.0)73 (4.4)
22 (1.3)
4 (0.2)251 (13.9)
168 (9.3)
82 (4.6)
1 (0.1)149 (8.3)
100 (5.6)
46 (2.6)
3 (0.2)477 (28.7)
202 (12.2)
259 (15.6)
16 (1.0)87 (5.3)
57 (3.5)
29 (1.8)
1 (0.1)155 (8.6)
101 (5.6)
52 (2.9)
2 (0.1)109 (6.1)
68 (3.8)40 (2.2)
1 (0.1)313 (18.9)
161 (9.7)
145 (8.7)
7 (0.4)61 (3.7)
35 (2.1)
25 (1.5)
1 (0.1)358 (19.9)

213 (11.9)

625 (37.7)

161 (9.8)

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.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Revised: 19 May 2021

23

Unsolicited Adverse Events
Serious Adverse Events
In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine orplacebo (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 yearsof age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events werereported 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 todetermine 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.
Non-Serious Adverse Events
In Study 2 in which 10,841 participants 16 through 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 theplacebo 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 placebogroup. 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) thatwould suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.
Adolescents 12 Through 15 Years of Age
In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents(1,131 Pfizer-BioNTech COVID-19 Vaccine; 1,129 placebo) were 12 through 15 years of age. Of these,
1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least
Revised: 19 May 2021

24

2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine. The safety evaluation in Study 2 isongoing.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity
among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo.
Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino,
6.4% were Asian, and 0.4% were American Indian/Alaska Native.
Solicited Local and Systemic Adverse Reactions
The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness
2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the
Pfizer-BioNTech COVID-19 Vaccine group.
Table 5: Study 2 – Frequency and Percentages of Adolescents With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age– Safety Population*
Pfizer-BioNTech
Pfizer-BioNTech
COVID-19 Vaccine
Placebo
COVID-19 Vaccine
Placebo
Dose 1
Dose 1
Dose 2
Dose 2aaa
N =1127
N =1127
N =1097
Na=1078
b
b
b
n (%)
n (%)
n (%)
nb (%)
Rednessc
Any (>2 cm)
65 (5.8)
12 (1.1)
55 (5.0)
10 (0.9)
Mild
44 (3.9)
11 (1.0)29 (2.6)
8 (0.7)
Moderate
20 (1.8)
1 (0.1)26 (2.4)
2 (0.2)
Severe1 (0.1)0 (0.0)0 (0.0)0 (0.0)c
Swelling
Any (>2 cm)
78 (6.9)
11 (1.0)
54 (4.9)
6 (0.6)
Mild
55 (4.9)9 (0.8)36 (3.3)
4 (0.4)Moderate
23 (2.0)
2 (0.2)18 (1.6)
2 (0.2)
Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)Pain at the injection
sited
Any
971 (86.2)
263 (23.3)
866 (78.9)
193 (17.9)
Mild
467 (41.4)
227 (20.1)
466 (42.5)
164 (15.2)
Moderate
493 (43.7)
36 (3.2)
393 (35.8)
29 (2.7)
Severe11 (1.0)0 (0.0)7 (0.6)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.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Revised: 19 May 2021

25

Table 6: Study 2 – Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age– Safety Population*
Pfizer-BioNTech
Pfizer-BioNTech
COVID-19 Vaccine
Placebo
COVID-19 Vaccine
Placebo
Dose 1
Dose 2
Dose 1
Dose 2
Na=1127
Na=1127
Na=1097
Na=1078nb (%)
nb (%)
nb (%)
nb (%)
Fever≥38.0℃
114 (10.1)
12 (1.1)
215 (19.6)
7 (0.6)≥38.0℃ to 38.4℃
74 (6.6)
8 (0.7)107 (9.8)
5 (0.5)>38.4℃ to 38.9℃
29 (2.6)
2 (0.2)83 (7.6)
1 (0.1)>38.9℃ to 40.0℃
10 (0.9)
2 (0.2)25 (2.3)
1 (0.1)>40.0℃
1 (0.1)0 (0.0)0 (0.0)0 (0.0)c
FatigueAny677 (60.1)
457 (40.6)
726 (66.2)
264 (24.5)
Mild
278 (24.7)
250 (22.2)
232 (21.1)
133 (12.3)
Moderate
384 (34.1)
199 (17.7)
468 (42.7)
127 (11.8)
Severe15 (1.3)
8 (0.7)26 (2.4)
4 (0.4)
HeadachecAny
623 (55.3)
396 (35.1)
708 (64.5)
263 (24.4)
Mild
361 (32.0)
256 (22.7)
302 (27.5)
169 (15.7)
Moderate
251 (22.3)
131 (11.6)
384 (35.0)
93 (8.6)
Severe11 (1.0)9 (0.8)22 (2.0)
1 (0.1)ChillscAny
311 (27.6)
109 (9.7)455 (41.5)
73 (6.8)
Mild
195 (17.3)
82 (7.3)
221 (20.1)
52 (4.8)
Moderate
111 (9.8)
25 (2.2)
214 (19.5)
21 (1.9)
Severe5 (0.4)2 (0.2)20 (1.8)
0 (0.0)Vomitingd
Any
31 (2.8)
10 (0.9)29 (2.6)
12 (1.1)
Mild
30 (2.7)
8 (0.7)25 (2.3)
11 (1.0)
Moderate
0 (0.0)2 (0.2)4 (0.4)1 (0.1)
Severe1 (0.1)0 (0.0)0 (0.0)0 (0.0)
DiarrheaeAny
90 (8.0)82 (7.3)
65 (5.9)43 (4.0)
Mild
77 (6.8)
72 (6.4)
59 (5.4)
38 (3.5)
Moderate
13 (1.2)
10 (0.9)
6 (0.5)5 (0.5)
Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)New or worsened
muscle painc
Any
272 (24.1)
148 (13.1)
355 (32.4)
90 (8.3)
Mild
125 (11.1)
88 (7.8)152 (13.9)
51 (4.7)
Moderate
145 (12.9)
60 (5.3)
197 (18.0)
37 (3.4)
Severe2 (0.2)0 (0.0)6 (0.5)2 (0.2)

Revised: 19 May 2021

26

New or worsened joint
painc
Any
Mild
Moderate
SevereUse of antipyretic or
pain medicationf

Pfizer-BioNTech
COVID-19 Vaccine
Dose 1
Na=1127nb (%)

Placebo
Dose 1
Na=1127nb (%)

Pfizer-BioNTech
COVID-19 Vaccine
Dose 2
Na=1097
nb (%)

Placebo
Dose 2
Na=1078nb (%)109 (9.7)
66 (5.9)42 (3.7)
1 (0.1)77 (6.8)
50 (4.4)
27 (2.4)
0 (0.0)173 (15.8)
91 (8.3)
78 (7.1)
4 (0.4)51 (4.7)
30 (2.8)
21 (1.9)
0 (0.0)413 (36.6)

111 (9.8)557 (50.8)

95 (8.8)

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.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Unsolicited Adverse Events
In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received
Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had atleast 30 days of follow-up after Dose 2.
Serious Adverse Events
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 0.1% of placebo recipients. There were no
notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse
events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.
Non-Serious Adverse Events
Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported
by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. From Dose 1
through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were
imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebogroup (1). There were no other notable patterns or numerical imbalances between treatment groups for specificcategories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech
COVID-19 Vaccine.
6.2

Post Authorization Experience

The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech
COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably
estimate their frequency or establish a causal relationship to vaccine exposure.
Revised: 19 May 2021

27

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions(e.g., rash, pruritus, urticaria, angioedema)
Gastrointestinal Disorders: diarrhea, vomiting
Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)8

REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND
VACCINE ADMINISTRATION ERRORS

See Overall Safety Summary (Section 6) for additional information.
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):• 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*

Serious adverse events are defined as:• Death• A life-threatening adverse event• Inpatient hospitalization or prolongation of existing hospitalization• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life
functions• A congenital anomaly/birth defect• An important medical event that based on appropriate medical judgement may jeopardize the individualand may require medical or surgical intervention to prevent one of the outcomes listed above

Instructions for Reporting to VAERS
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 info@vaers.org.
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.

Revised: 19 May 2021

28

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 toprovide 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.
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).
Other Reporting Instructions
Vaccination providers may report to VAERS other adverse events that are not required to be reported using thecontact 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.
WebsiteFax number

Telephone number

www.pfizersafetyreporting.com

1-866-635-8337

1-800-438-1985

10

DRUG INTERACTIONSThere are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine withother vaccines.
11

USE IN SPECIFIC POPULATIONS

11.1

Pregnancy

Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, theestimated 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 topregnant women are insufficient to inform vaccine-associated risks in pregnancy.
In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same
quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included
in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the
Revised: 19 May 2021

29

intramuscular route on four occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No
vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in
the study.
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.
11.3

Pediatric Use

Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 through 18 years ofage is based on safety and effectiveness data in this age group and in adults.
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals
younger than 12 years of age.
11.4

Geriatric Use

Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and theirdata 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 vialmust 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 withnatural rubber latex.
14

CLINICAL PHARMACOLOGY

14.1

Mechanism of Action

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.
Revised: 19 May 2021

30

18

CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1

Efficacy in Participants 16 Years of Age and Older

Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind,
dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older.
Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age
and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who
were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19.
Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants
with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B
virus (HBV).
In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, 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.
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 7 presents
the specific demographic characteristics in the studied population.
Table 7: Demographics (population for the primary efficacy endpoint)a
Pfizer-BioNTech
COVID-19 Vaccine(N=18,242)
n (%)
Sex
Male
9318 (51.1)
Female8924 (48.9)
Age (years)
Mean (SD)50.6 (15.70)
Median52.0
Min, max(12, 89)
Age group≥12 through 15 yearsb
46 (0.3)≥16 through 17 years
66 (0.4)≥16 through 64 years
14,216 (77.9)≥65 through 74 years
3176 (17.4)≥75 years
804 (4.4)
Race
White
15,110 (82.8)
Black or African American
1617 (8.9)
American Indian or Alaska Native
118 (0.6)
Asian
815 (4.5)
Native Hawaiian or other Pacific Islander
48 (0.3)cOther
534 (2.9)
Revised: 19 May 2021

Placebo(N=18,379)
n (%)
9225 (50.2)
9154 (49.8)
50.4 (15.81)
52.0(12, 91)42 (0.2)
68 (0.4)
14,299 (77.8)
3226 (17.6)
812 (4.4)
15,301 (83.3)
1617 (8.8)
106 (0.6)810 (4.4)
29 (0.2)
516 (2.8)31Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Not reported
Comorbiditiesd
Yes
No

Pfizer-BioNTech
COVID-19 Vaccine(N=18,242)n (%)

Placebo(N=18,379)
n (%)

4886 (26.8)
13,253 (72.7)
103 (0.6)4857 (26.4)
13,412 (73.0)
110 (0.6)8432 (46.2)
9810 (53.8)

8450 (46.0)
9929 (54.0)a.

All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no otherimportant protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days
after Dose 2.
b. 100 participants 12 through 15 years of age with limited follow-up in the randomized population received at least one dose (49in the vaccine group and 51 in the placebo group). Some of these participants were included in the efficacy evaluation
depending on the population analyzed. They contributed to exposure information but with no confirmed COVID-19 cases, anddid not affect efficacy conclusions.
c. Includes multiracial and not reported.
d. Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease• Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) ormoderate to severe asthma• Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, andpulmonary hypertension)• Obesity (body mass index ≥30 kg/m2)• Diabetes (Type 1, Type 2 or gestational)• Liver disease• Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation)

The population in the primary efficacy analysis included all participants 12 years of age and older who had beenenrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020.
Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020,
16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began
enrollment from October 15, 2020.
The vaccine efficacy information is presented in Table 8.

Revised: 19 May 2021

32

Table 8: 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
COVID-19 Vaccine
Placeboa
N =18,198
Na=18,325
Cases
Cases
b
n1
n1b
Vaccine Efficacy %cdSubgroup
Surveillance Time (n2 ) Surveillance Timec (n2d)(95% CI)
8
162
All subjectse
2.214 (17,411)
2.222 (17,511)
95.0 (90.3, 97.6)f
7
143
16 through 64 years
1.706 (13,549)
1.710 (13,618)
95.1 (89.6, 98.1)g1
19
65 years and older
0.508 (3848)
0.511 (3880)
94.7 (66.7, 99.9)gFirst COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior
SARS-CoV-2 infection
Pfizer-BioNTech
COVID-19 Vaccine
Placeboa
N =19,965
Na=20,172
Cases
Cases
b
n1
n1b
Vaccine Efficacy %cdSubgroup
Surveillance Time (n2 ) Surveillance Timec (n2d)(95% CI)
9169
All subjectse
2.332 (18,559)
2.345 (18,708)
94.6 (89.9, 97.3)f
8150
16 through 64 years
1.802 (14,501)
1.814 (14,627)
94.6 (89.1, 97.7)g1
19
65 years and older
0.530 (4044)
0.532 (4067)
94.7 (66.8, 99.9)gNote: 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 orincreased 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 unscheduledvisit 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 theendpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. No confirmed cases were identified in adolescents 12 through 15 years of age.
f. Credible interval for vaccine efficacy (VE) was calculated using a beta-binomial model with a beta (0.700102, 1) prior for θ=r(1VE)/(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.

18.2

Efficacy in Adolescents 12 Through 15 Years of Age

A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.
Revised: 19 May 2021

33

The efficacy information in adolescents 12 through 15 years of age is presented in Table 9.
Table 9: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidenceof Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded
Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable
Efficacy (7 Days) Population
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without
evidence of prior SARS-CoV-2 infection*
Pfizer-BioNTech
COVID-19 Vaccine
Placebo
Na=1005
Na=978
Cases
Cases
n1b
n1b
Vaccine Efficacy %cdcdSurveillance Time (n2 ) Surveillance Time (n2 )(95% CIe)
Adolescents016
12 through 15 years of age
0.154 (1001)
0.147 (972)100.0 (75.3, 100.0)
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with orwithout evidence of prior SARS-CoV-2 infection
Pfizer-BioNTech
Placebo
COVID-19 Vaccine
Na=1119
Na=1110
Cases
Cases
n1b
n1b
Vaccine Efficacy %cdcdSurveillance Time (n2 ) Surveillance Time (n2 )(95% CIe)
Adolescents
018
12 through 15 years of age
0.170 (1109)
0.163 (1094)
100.0 (78.1, 100.0)
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 orincreased 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 unscheduledvisit 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 theendpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for surveillance time.

18.3

Immunogenicity in Adolescents 12 Through 15 Years of Age

In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers 1 month after Dose 2 in a randomly selected
subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents
12 through 15 years of age to participants 16 through 25 years of age who had no serological or virologicalevidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10).

Revised: 19 May 2021

34

Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer – Comparison of Adolescents
12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity
Subset) –Participants Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2
Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19 Vaccine
12 Through 15 Years 16 Through 25 Years
12 Through 15 Years/
na=190na=17016 Through 25 Years
Met
Noninferiority
Time
GMTc
GMTc
GMRd
Objectivee
b
c
c
d
Assay
Point
(95% CI )(95% CI )(95% CI )(Y/N)
SARS-CoV-2
neutralization
1 monthassay - NT50
after
1239.5705.1
1.76(titer)f
Dose 2(1095.5, 1402.5)(621.4, 800.2)(1.47, 2.10)
Y
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit ofquantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory
syndrome coronavirus 2.
Note: Participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) 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 and2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis.
a. n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time
point.
b. Protocol-specified timing for blood sample collection.
c. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs(based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
d. GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1 [12through 15 years of age] – Group 2 [16 through 25 years of age]) and the corresponding CI (based on the Student t
distribution).
e. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
f. SARS-CoV-2 50% neutralization titers (NT50) were determined using the SARS-CoV-2 mNeonGreen Virus
Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus
neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of
the virus is neutralized.

19

HOW SUPPLIED/STORAGE AND HANDLING

Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are suppliedin a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials(NDC 59267-1000-2). After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state thatafter dilution, a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information
regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels andcartons.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Frozen Vials Prior to Use
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 preferably store in an
ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF) until the expiry date printed on thelabel. Alternatively, vials may be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials must be kept
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35

frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to -15°C (-13°F
to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -80ºC to -60ºC(-112ºF to -76ºF). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked
and should not exceed 2 weeks.
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 thecontainer 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 of the vials between -96°C to -60°C (-141°F to -76°F) is notconsidered an excursion from the recommended storage condition.
Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot be transported at -90°C to -60°C(-130°F to -76°F), vials may be transported at -25°C to -15°C (-13°F to 5°F). Any hours used for transport
at -25°C to -15°C (-13°F to 5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F).
Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time to the recommended storage
condition of -80ºC to -60ºC (-112ºF to -76ºF).
Thawed Vials Before Dilution
Thawed Under Refrigeration
Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 1 month. A carton of
25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer
number of vials will thaw in less time.
Thawed at Room Temperature
For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials
can be handled in room light conditions.
Vials must reach room temperature before dilution.
Undiluted vials may be stored at room temperature for no more than 2 hours.
Transportation of Thawed Vials
Available data support transportation of one or more thawed vials at 2°C to 8°C (35°F to 46°F) for up to
12 hours.
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.
20

PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.
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36

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.
Websitewww.cvdvaccine.com

Telephone number
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 GmbHAn der Goldgrube 1255131 Mainz, Germany
LAB-1457-8.2b
Revised: 19 May 2021

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