Burk Declaration
- Date
- 2021-12-17
Summary
Document 40-5 in Case 2:21-cv-00702-CLM in the U.S. District Court, N.D. of Alabama, filed December 17, 2021 and labeled Burk Declaration Exhibit 5. The exhibit is the FDA Emergency Use Authorization fact sheet for healthcare providers administering the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age, revised 29 October 2021. It covers storage, dilution and administration of the orange-cap vial as a 2-dose primary series of 0.2 mL doses given 3 weeks apart. The fact sheet also sets out contraindications, warnings including myocarditis and pericarditis, adverse reactions and mandatory reporting requirements for vaccination providers. The 44-page exhibit ends with Full EUA Prescribing Information on storage and patient counseling.
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Case 2:21-cv-00702-CLM Document 40-5 Filed 12/17/21 Page 1 of 44 FILED
2021 Dec-17 PM 01:27
U.S. DISTRICT COURT
N.D. OF ALABAMA
Burk Declaration
Exhibit 5
Case 2:21-cv-00702-CLM Document 40-5 Filed 12/17/21 Page 2 of 44
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)
FOR 5 THROUGH 11 YEARS OF AGE
DILUTE BEFORE USE
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 5 years of age and older.
This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied
in a multiple dose vial with an orange cap and a label with an orange border
and which is authorized for use to provide a 2-dose primary series to
individuals 5 through 11 years of age. The vial labels state: Age 5y to <12y.
The carton labels state: For age 5 years to <12 years.
Pfizer-BioNTech COVID-19 Vaccine which is supplied in a multiple dose vial
with an orange cap and a label with an orange border, should not be used in
individuals 12 years of age and older. 1
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 of
Multisystem 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 FOR
PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER
EMERGENCY USE AUTHORIZATION” for reporting requirements.
The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular
injection.
The Pfizer-BioNTech COVID-19 Vaccine, which is supplied in a multiple dose vial
with an orange cap and a label with an orange border, is administered, after
1 Notwithstanding the age limitations for use of the different formulations and presentations
described above, individuals who will turn from 11 years to 12 years of age between their first and
second dose in the primary regimen may receive, for either dose, either: (1) the Pfizer-BioNTech
COVID-19 Vaccine formulation authorized for use in individuals 5 through 11 years of age (each 0.2
mL dose containing 10 mcg modRNA) (orange cap); or (2) COMIRNATY or one of the Pfizer-
BioNTech COVID-19 Vaccine formulations authorized for use in individuals 12 years of age and
older (each 0.3 mL dose containing 30 mcg modRNA) (gray and purple cap).
Revised: 29 October 2021
Case 2:21-cv-00702-CLM Document 40-5 Filed 12/17/21 Page 3 of 44
dilution, as a primary series of 2 doses (0.2 mL each) 3 weeks apart in individuals
5 through 11 years of age.
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 the
novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a
respiratory illness that can affect other organs. People with COVID-19 have
reported 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.
DOSAGE AND ADMINISTRATION
The storage, preparation, and administration information in this Fact Sheet apply to
the Pfizer-BioNTech COVID-19 Vaccine which is supplied in a multiple dose vial
with an orange cap and a label with an orange border and MUST BE DILUTED
before use.
Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Orange Cap and
Label with Orange Border
Doses Per
Vial After
Age Range Dilution Information Dilution Dose Volume
Dilute with 1.3 mL
5 through 11 years
sterile 0.9% Sodium
(Vial labels state: 10 0.2 mL
Chloride Injection,
Age 5y to <12y)
USP prior to use
Storage and Handling
During storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light.
Do not refreeze thawed vials.
Revised: 29 October 2021 2
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Vial Storage Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange
caps and labels with orange borders may arrive frozen at ultra-cold conditions in
thermal containers with dry ice or at -25°C to -15°C (-13°F to 5°F).
Once received, frozen vials may be immediately transferred to the refrigerator [2ºC
to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week
refrigerated expiry date should be recorded on the carton at the time of transfer. A
carton of 10 vials may take up to 4 hours to thaw at this temperature.
Alternatively, frozen vials may be stored in an ultra-low temperature freezer
at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to
5°F). Once vials are thawed they should not be refrozen.
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange
caps and labels with orange borders may also arrive at 2°C to 8°C. If received at
2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been
updated to reflect the 10-week refrigerated expiry date.
Regardless of storage condition, vaccines should not be used after 6 months from
the date of manufacture printed on the vial and cartons.
Vial Storage During Use
If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room
temperature [up to 25ºC (77ºF)] for 30 minutes.
Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and
labels with orange borders may be stored at 8°C to 25°C (46°F to 77°F) for a total
of 12 hours prior to dilution.
After dilution, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials
should be discarded 12 hours after dilution.
Vial labels and cartons may state that a vial should be discarded 6 hours after the
first puncture. The information in this Fact Sheet supersedes the number of hours
printed on vial labels and cartons.
Transportation of Vials
If local redistribution is needed, undiluted vials may be transported at -90°C
to -60°C (-130°F to -76°F) or at 2°C to 8°C (35°F to 46°F).
Dosing and Schedule
The Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with
orange caps and labels with orange borders is administered intramuscularly as a
Revised: 29 October 2021 3
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primary series of 2 doses (0.2 mL each) 3 weeks apart to individuals 5 through
11 years of age.
Pfizer-BioNTech COVID-19 Vaccine that is supplied in vials with purple or gray
caps should not be used for individuals 5 through 11 years of age because of the
potential for vaccine administration errors, including dosing errors.
Dose Preparation
Each vial MUST BE DILUTED before administering the vaccine.
Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial with an orange
cap and a label with an orange border contains a volume of 1.3 mL and is
supplied as a frozen suspension that does not contain preservative.
• Each vial must be thawed before dilution.
o Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at
room temperature [up to 25ºC (77ºF)].
o Refer to thawing instructions in the panels below.
Dilution
Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection,
USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine.
ONLY use sterile 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. Do not add
more than 1.3 mL of diluent.
After dilution, 1 vial contains 10 doses of 0.2 mL.
Revised: 29 October 2021 4
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Dilution and Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and a Label with
Orange Border – VIAL VERIFICATION
• Verify that the vial of
Pfizer-BioNTech COVID-19
Vaccine has an orange
plastic cap and a label with
an orange border and states
“Age 5y to < 12y.”
Orange plastic cap and label with
orange border.
Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with
Orange Border – 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 10 vials may
take up to 4 hours to
Store in the
thaw, and thawed vials
refrigerator for
can be stored in the
up to 10 weeks
refrigerator for up to
prior to use.
10 weeks.
o Allowing vial(s) to sit at
room temperature [up to
25ºC (77ºF)] for
30 minutes.
o Vials may be stored at
room temperature [up to
25ºC (77ºF)] for up to
12 hours prior to use.
Revised: 29 October 2021 5
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Dilution and Preparation Instructions
• Before dilution, mix by
inverting 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 opaque amorphous
particles.
• Do not use if liquid is
discolored or if other
particles are observed.
Gently × 10
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Dilution and Preparation Instructions
• Gently invert the vial
containing the Pfizer-
BioNTech COVID-19
Vaccine 10 times to mix.
• Do not shake.
• Inspect the vaccine in the
vial.
• The vaccine will be a white
to off-white suspension. Do
not use if vaccine is
discolored or contains
particulate matter.
Gently × 10
• Record the date and time of
first vial puncture on the vial
label.
• Store between 2°C to 25°C
(35°F to 77°F).
• Discard any unused vaccine
12 hours after dilution.
Use within 12 hours after dilution.
Revised: 29 October 2021 8
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Dilution and Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with
Orange Border - WITHRAWAL OF INDIVIDUAL 0.2 mL DOSES
• Using aseptic technique,
cleanse the vial stopper
with a single-use antiseptic
swab, and withdraw 0.2 mL
of the Pfizer-BioNTech
COVID-19 Vaccine
preferentially using a low
dead-volume syringe and/or
needle.
• Each dose must contain
0.2 mL of vaccine.
• If the amount of vaccine
remaining in the vial cannot
provide a full dose of
0.2 mL, discard the vial and
any excess volume.
Withdraw 0.2 mL dose of vaccine.
• Administer immediately.
Administration
Visually inspect each dose in the dosing syringe prior to administration. The
vaccine will be a white to off-white suspension. During the visual inspection,
• verify the final dosing volume of 0.2 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 with orange caps and
labels with orange borders contain 10 doses of 0.2 mL of vaccine. Low
dead-volume syringes and/or needles can be used to extract 10 doses from a
single vial. If standard syringes and needles are used, there may not be sufficient
volume to extract 10 doses from a single vial. Irrespective of the type of syringe
and needle:
• Each dose must contain 0.2 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of
0.2 mL, discard the vial and content.
• Do not pool excess vaccine from multiple vials.
Revised: 29 October 2021 9
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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
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 (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-
considerations/managing-anaphylaxis.html).
Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis,
particularly within 7 days following the second dose. The observed risk is higher
among males under 40 years of age than among females and older males. The
observed risk is highest in males 12 through 17 years of age. Although some
cases required intensive care support, available data from short-term follow-up
suggest that most individuals have had resolution of symptoms with conservative
management. Information is not yet available about potential long-term sequelae.
The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of
myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-
considerations/myocarditis.html).
Syncope
Syncope (fainting) may occur in association with administration of injectable
vaccines, in particular in adolescents. Procedures should be in place to avoid injury
from fainting.
Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant
therapy, may have a diminished immune response to the Pfizer-BioNTech
COVID-19 Vaccine.
Limitation of Effectiveness
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Revised: 29 October 2021 10
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Adverse Reactions
Adverse Reactions in Clinical Trials
Adverse reactions in children 5 through 11 years following administration of the
primary series included pain at the injection site, fatigue, headache, injection site
redness, injection site swelling, muscle pain, chills, fever, joint pain,
lymphadenopathy, nausea, malaise, decreased appetite, and rash (see Full EUA
Prescribing Information).
Adverse Reactions in Individuals 12 years of Age and Older in Post Authorization
Experience
Severe allergic reactions, including anaphylaxis, and other hypersensitivity
reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in
extremity (arm), and syncope have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
Myocarditis and pericarditis 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.
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 their
caregiver, information consistent with the “Vaccine Information Fact Sheet for
Recipients and Caregivers” (and provide a copy or direct the individual to the
website www.cvdvaccine.com to obtain the Vaccine Information 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.
Revised: 29 October 2021 11
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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.
Provide the v-safe information sheet to vaccine recipients/caregivers and
encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary
smartphone-based tool that uses text messaging and web surveys to check in with
people 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 VACCINE
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION 2
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):
1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals
5 years of age and older.
2. The vaccination provider must communicate to the individual receiving the
Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information
consistent with the “Vaccine Information Fact Sheet for Recipients and
Caregivers” prior to the individual receiving Pfizer-BioNTech COVID-19
Vaccine.
3. The vaccination provider must include vaccination information in the
state/local jurisdiction’s Immunization Information System (IIS) or other
designated system.
4. The vaccination provider is responsible for mandatory reporting of the
following 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 adults and
children, and
• cases of COVID-19 that result in hospitalization or death.
2 Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the
same reporting requirements.
Revised: 29 October 2021 12
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Complete and submit reports to VAERS online at
https://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 the
report.
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 surgical
intervention to prevent one of the outcomes listed above.
OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC.
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.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985
Revised: 29 October 2021 13
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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 may be clinical 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 the
provider requirements. Vaccination providers may not charge any fee for the
vaccine and may not charge the vaccine recipient any out-of-pocket charge for
administration. 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.
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 EUA
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. Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial
Revised: 29 October 2021 14
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with an orange cap and a label with an orange border is authorized for use to
provide a 2-dose primary series in individuals 5 through 11 years of age.
FDA issued this EUA, based on Pfizer-BioNTech’s request and submitted data.
For the authorized uses, 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.
The Countermeasures Injury Compensation Program
The Countermeasures Injury Compensation Program (CICP) is a federal program
that has been created to help pay for related costs of medical care and other
specific 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 public
health 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
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1502-0.4
Revised: 29 October 2021
END SHORT VERSION FACT SHEET
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Long Version (Full EUA Prescribing Information) Begins On Next Page
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FULL EMERGENCY USE
AUTHORIZATION (EUA) PRESCRIBING
INFORMATION
PFIZER-BIONTECH COVID-19 VACCINE
10 DRUG INTERACTIONS
11 USE IN SPECIFIC POPULATIONS
FULL EMERGENCY USE AUTHORIZATION
11.1 Pregnancy
PRESCRIBING INFORMATION: CONTENTS* 11.2 Lactation
11.3 Pediatric Use
1 AUTHORIZED USE 13 DESCRIPTION
2 DOSAGE AND ADMINISTRATION 14 CLINICAL PHARMACOLOGY
2.1 Preparation for Administration 14.1 Mechanism of Action
2.2 Administration Information 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR
2.3 Vaccination Schedule EUA
3 DOSAGE FORMS AND STRENGTHS 18.1 Efficacy of Primary Series in Participants 16 Years of Age and
4 CONTRAINDICATIONS Older
5 WARNINGS AND PRECAUTIONS 18.2 Efficacy of Primary Series in Children 5 Through 11 Years of Age
5.1 Management of Acute Allergic Reactions 18.3 Immunogenicity of Primary Series in Children 5 Through 11 Years
5.2 Myocarditis and Pericarditis of Age
5.3 Syncope 19 HOW SUPPLIED/STORAGE AND HANDLING
5.4 Altered Immunocompetence 20 PATIENT COUNSELING INFORMATION
5.5 Limitation of Effectiveness 21 CONTACT INFORMATION
6 OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience * Sections or subsections omitted from the full emergency use authorization
6.2 Post Authorization Experience prescribing information are not listed.
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING
ADVERSE EVENTS AND VACCINE ADMINISTRATION
ERRORS
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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 5 years of age and older.
This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with an
orange cap and a label with an orange border and which is authorized for use in individuals 5 through 11 years
of age. The vial labels state: Age 5y to <12y. The carton labels state: For age 5 years to <12 years.
2 DOSAGE AND ADMINISTRATION
For intramuscular injection only.
The storage, preparation, and administration information in this Fact Sheet apply to the Pfizer-BioNTech
COVID-19 Vaccine, which is supplied in a multiple dose vial with an orange cap and a label with an orange
border.
Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Orange Cap and Label with Orange
Border
Doses Per Vial
Age Range Dilution Information After Dilution Dose Volume
5 through 11 years Dilute with 1.3 mL sterile 0.9%
(Vial labels state: Age 5y Sodium Chloride Injection, USP 10 0.2 mL
to <12y) prior to use
2.1 Preparation for Administration
Each vial MUST BE DILUTED before administering the vaccine.
Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with an orange cap and a label with an
orange border contains a volume of 1.3 mL and is supplied as a frozen suspension that does not contain
preservative.
• Each vial must be thawed before dilution.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to
25ºC (77ºF)].
• Refer to thawing instructions in the panels below.
Dilution
• Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided)
to form the Pfizer-BioNTech COVID-19 Vaccine.
• ONLY use sterile 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
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Injection or any other diluent. Do not add more than 1.3 mL of diluent.
• After dilution, 1 vial contains 10 doses of 0.2 mL.
Dilution and Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and a Label with Orange Border – VIAL
VERIFICATION
• Verify that the vial of Pfizer-BioNTech
COVID-19 Vaccine has an orange
plastic cap and a label with an orange
border and states “Age 5y to < 12y.”.
Orange plastic cap and label with orange border.
Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border –
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
Store in the 46ºF)]. A carton of 10 vials may
refrigerator for take up to 4 hours to thaw, and
up to 10 weeks thawed vials can be stored in the
prior to use. refrigerator for up to 10 weeks.
o Allowing vial(s) to sit at room
temperature [up to 25ºC (77ºF)] for
30 minutes.
o Vials may be stored at room
temperature [up to 25ºC (77ºF)] for
12 hours prior to use.
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Dilution and Preparation Instructions
• Before dilution, mix by inverting
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
opaque amorphous particles.
• Do not use if liquid is discolored or if
other particles are observed.
Gently × 10
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Dilution and Preparation Instructions
• Gently invert the vial containing the
Pfizer-BioNTech COVID-19 Vaccine
10 times to mix.
• Do not shake.
• Inspect the vaccine in the vial.
• The vaccine will be a white to
off-white suspension. Do not use if
vaccine is discolored or contains
particulate matter.
Gently × 10
• Record the date and time of first vial
puncture on the vial label.
• Store between 2°C to 25°C (35°F to
77°F).
• Discard any unused vaccine 12 hours
after dilution.
Use within 12 hours after dilution.
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Dilution and Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Orange Cap and Label with Orange Border -
WITHRAWAL OF INDIVIDUAL 0.2 mL DOSES
• Using aseptic technique, cleanse the
vial stopper with a single-use antiseptic
swab, and withdraw 0.2 mL of the
Pfizer-BioNTech COVID-19 Vaccine
preferentially using a low dead-volume
syringe and/or needle.
• Each dose must contain 0.2 mL of
vaccine.
• If the amount of vaccine remaining in
the vial cannot provide a full dose of
0.2 mL, discard the vial and any excess
volume.
• Administer immediately.
Withdraw 0.2 mL dose of vaccine
2.2 Administration Information
Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be a white to
off-white suspension. During the visual inspection,
• verify the final dosing volume of 0.2 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 with orange caps and labels with orange borders
contain 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract
10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to
extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
• Each dose must contain 0.2 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and
content.
• Do not pool excess vaccine from multiple vials.
2.3 Vaccination Schedule
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses
(0.2 mL each) 3 weeks apart in individuals 5 through 11 years of age.
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3 DOSAGE FORMS AND STRENGTHS
Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection.
After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with
orange caps and labels with orange borders is 0.2 mL for individuals 5 through 11 years of age [see Dosage and
Administration (2.1)].
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 (CDC) guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
5.2 Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days
following the second dose. The observed risk is higher among males under 40 years of age than among
females and older males. The observed risk is highest in males 12 through 17 years of age. Although some
cases required intensive care support, available data from short-term follow-up suggest that most individuals
have had resolution of symptoms with conservative management. Information is not yet available about
potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
5.3 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in
adolescents. Procedures should be in place to avoid injury from fainting.
5.4 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a
diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
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5.5 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. 3 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 a clinical study in children 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine
containing 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of
SARS-CoV-2 (10 mcg modRNA), adverse reactions following administration of any primary series dose
included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%),
injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%),
lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).
Post Authorization Experience in Individuals 12 Years of Age and Older
Severe allergic reactions, including anaphylaxis, have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
Myocarditis and pericarditis 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 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 the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 5 years of
age and older in 3 clinical studies conducted in the United States, Europe, Turkey, South Africa, and South
America.
Study BNT162-01 (Study 1) was a Phase 1/2, 2-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 (30 mcg modRNA);
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) and 2,260 adolescents are 12 through 15 years of age
(1,131 and 1,129 in the vaccine and placebo groups, respectively). Study C4591007 (Study 3) is a Phase 1/2/3
multicenter, randomized, dose-finding, open-label (Phase 1) and multinational, saline placebo-controlled,
3
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
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observer-blind, immunogenicity and efficacy (Phase 2/3) study that has enrolled 4,695 participants 5 through
11 years of age, of whom 3109 participants received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA)
and 1538 participants received placebo in Phase 2/3.
In Study 2 and Study 3, all participants 5 through 11 years of age, 12 through 15 years of age, and 16 years of
age and older in the reactogenicity 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
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].
Tables 1 and 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 (10 mcg modRNA) and placebo in children
5 through 11 years of age.
Children 5 Through 11 Years of Age
In an analysis of Study 3 Phase 2/3, based on data up to the cutoff date of September 06, 2021,
2,268 participants [1,518 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA); 750 placebo] were
5 through 11 years of age. Of these, 2,158 (95.1%) [1,444 Pfizer-BioNTech COVID-19 Vaccine (10 mcg
modRNA) and 714 placebo] participants have been followed for at least 2 months after the second dose. An
analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants [1,591 Pfizer
BioNTech COVID-19 Vaccine (10 mcg modRNA) and 788 placebo], of whom 71.2% had a follow-up period
for at least 2 weeks after Dose 2 up to the cutoff date of October 8, 2021. The safety evaluation in Study 3 is
ongoing.
Demographic characteristics in Study 3 were generally similar with regard to age, gender, race, and ethnicity
among participants 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine (10 mcg
modRNA) and those who received placebo. Among the 4,647 participants 5 through 11 years of age who
received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA), 51.8% were male and
48.2% were female, 77.3% were White, 5.8% were Black or African American, 16.9% were Hispanic/Latino,
8.3% 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 2 was 2.3 days (range 1 to 11 days), for redness
2.2 days (range 1 to 10 days), and for swelling 2.2 days (range 1 to 10 days) for children in the Pfizer-BioNTech
COVID-19 Vaccine (10 mcg modRNA) group up to the cutoff date of September 06, 2021.
Table 1: Study 3 – Frequency and Percentages of Participants With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Children 5 Through 11 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=1511 Na,b=748 Na=1501 Na,b=740
nc (%) nc (%) nc (%) nc (%)
d
Redness
Any (≥0.5 cm) 222 (14.7) 43 (5.7) 278 (18.5) 40 (5.4)
Mild 143 (9.5) 37 (4.9) 143 (9.5) 31 (4.2)
Moderate 79 (5.2) 6 (0.8) 132 (8.8) 9 (1.2)
Severe 0 0 3 (0.2) 0
Swellingd
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Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1511 Na,b=748 Na=1501 Na,b=740
nc (%) nc (%) nc (%) nc (%)
Any (≥0.5 cm) 158 (10.5) 20 (2.7) 229 (15.3) 20 (2.7)
Mild 85 (5.6) 13 (1.7) 117 (7.8) 15 (2.0)
Moderate 72 (4.8) 7 (0.9) 112 (7.5) 5 (0.7)
Severe 1 (0.1) 0 0 0
Pain at the injection sitee
Any 1119 (74.1) 234 (31.3) 1065 (71.0) 218 (29.5)
Mild 890 (58.9) 204 (27.3) 793 (52.8) 192 (25.9)
Moderate 225 (14.9) 30 (4.0) 267 (17.8) 26 (3.5)
Severe 4 (0.3) 0 5 (0.3) 0
Note: Reactions were collected in an 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. The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2
in the placebo group, due to an e-diary error.
c. n = Number of participants with the specified reaction.
d. Mild: ≥0.5 to ≤2.0 cm; Moderate: >2.0 to ≤7.0 cm; Severe: >7.0 cm.
e. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
* Randomized participants who received at least 1 dose of the study intervention.
± Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
Table 2: Study 3 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Children 5 Through 11 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=1511 Na,b=748 Na=1501 Na,b=740
nc (%) nc (%) nc (%) nc (%)
Fever
≥38.0℃ 38 (2.5) 10 (1.3) 98 (6.5) 9 (1.2)
≥38.0℃ to 38.4℃ 23 (1.5) 4 (0.5) 51 (3.4) 5 (0.7)
>38.4℃ to 38.9℃ 12 (0.8) 5 (0.7) 38 (2.5) 3 (0.4)
>38.9℃ to 40.0℃ 3 (0.2) 1 (0.1) 8 (0.5) 1 (0.1)
>40.0℃ 0 0 1 (0.1) 0
d
Fatigue
Any 508 (33.6) 234 (31.3) 592 (39.4) 180 (24.3)
Mild 333 (22.0) 150 (20.1) 321 (21.4) 96 (13.0)
Moderate 171 (11.3) 83 (11.1) 260 (17.3) 83 (11.2)
Severe 4 (0.3) 1 (0.1) 11 (0.7) 1 (0.1)
Headached
Any 339 (22.4) 180 (24.1) 420 (28.0) 138 (18.6)
Mild 249 (16.5) 131 (17.5) 281 (18.7) 93 (12.6)
Moderate 88 (5.8) 45 (6.0) 136 (9.1) 45 (6.1)
Severe 2 (0.1) 4 (0.5) 3 (0.2) 0
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Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1511 Na,b=748 Na=1501 Na,b=740
nc (%) nc (%) nc (%) nc (%)
Chillsd
Any 70 (4.6) 35 (4.7) 147 (9.8) 32 (4.3)
Mild 54 (3.6) 30 (4.0) 105 (7.0) 24 (3.2)
Moderate 16 (1.1) 5 (0.7) 40 (2.7) 7 (0.9)
Severe 0 0 2 (0.1) 1 (0.1)
e
Vomiting
Any 33 (2.2) 11 (1.5) 28 (1.9) 6 (0.8)
Mild 26 (1.7) 11 (1.5) 27 (1.8) 6 (0.8)
Moderate 7 (0.5) 0 1 (0.1) 0
Severe 0 0 0 0
f
Diarrhea
Any 89 (5.9) 31 (4.1) 79 (5.3) 35 (4.7)
Mild 79 (5.2) 31 (4.1) 72 (4.8) 32 (4.3)
Moderate 10 (0.7) 0 7 (0.5) 3 (0.4)
Severe 0 0 0 0
New or worsened muscle paind
Any 137 (9.1) 51 (6.8) 175 (11.7) 55 (7.4)
Mild 96 (6.4) 35 (4.7) 116 (7.7) 38 (5.1)
Moderate 40 (2.6) 16 (2.1) 58 (3.9) 17 (2.3)
Severe 1 (0.1) 0 1 (0.1) 0
New or worsened joint paind
Any 50 (3.3) 41 (5.5) 78 (5.2) 27 (3.6)
Mild 34 (2.3) 31 (4.1) 57 (3.8) 20 (2.7)
Moderate 16 (1.1) 10 (1.3) 21 (1.4) 7 (0.9)
Severe 0 0 0 0
Use of antipyretic or
pain medicationg 217 (14.4) 62 (8.3) 296 (19.7) 60 (8.1)
Note: Events and use of antipyretic or pain medication were collected in an 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. The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after
Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error.
c. n = Number of participants with the specified reaction.
d. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
e. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
f. 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.
g. Severity was not collected for use of antipyretic or pain medication.
* Randomized participants who received at least 1 dose of the study intervention.
± Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
Unsolicited Adverse Events
In the following analyses of Study 3 in children 5 through 11 years of age (1,518 of whom received
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 750 of whom received placebo), 99.5% of
participants had at least 30 days of follow-up after Dose 2.
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Serious Adverse Events
In 1 group of participants (initial enrollment cohort) with a median of 2.3 months follow-up post Dose 2, no
serious adverse events were reported that were considered related to vaccination. In a second group of
participants (expansion cohort) with a median of 2.4 weeks follow-up post Dose 2, no serious adverse events
were reported that were considered related to vaccination.
Non-Serious Adverse Events
In 1 group of participants (initial enrollment cohort), non-serious adverse events from Dose 1 through up to
30 days after Dose 2 up to the cutoff date of September 06, 2021, in ongoing follow-up were reported by
10.9% of Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) recipients and by 9.1% of placebo
recipients. In this group of participants, >99% had follow-up 30 days post Dose 2. In a second group of
participants (expansion cohort) for which the median follow-up was 2.4 weeks (range 0 – 3.7 weeks), non-
serious adverse events from Dose 1 through the cutoff date of October 8, 2021, were reported by 7.1% of
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) recipients and by 6.3% of placebo recipients.
In the initial enrollment cohort, from Dose 1 through 30 days after Dose 2, lymphadenopathy was reported in 13
(0.9%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 1 (0.1%) in the
placebo group. In the expansion cohort from Dose 1 through the cut-off date, lymphadenopathy was reported in
6 (0.4%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 3 (0.4%) in the
placebo group. There were no other notable patterns between treatment groups for specific categories of non-
serious adverse events that would 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 (30 mcg modRNA); 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 2 months after the second dose. The safety evaluation in Study 2 is ongoing.
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 and
49.9% 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.
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 at
least 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.
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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 placebo
group (1). There were no other notable patterns or numerical imbalances between treatment groups for specific
categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech
COVID-19 Vaccine.
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
(30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of
2 months after the second dose.
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.
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 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 = 7,960, placebo = 7,934), 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.
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 7,960 participants 56 years of age and older
received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in
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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. 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 4 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.
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.
Cardiac Disorders: myocarditis, pericarditis
Gastrointestinal Disorders: diarrhea, vomiting
Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions
(e.g., rash, pruritus, urticaria, angioedema)
Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)
Nervous System Disorders: syncope
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND
VACCINE ADMINISTRATION ERRORS 4
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
4
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
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*
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 surgical intervention to prevent 1 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 1 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.
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
1 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.
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.
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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 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.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985
10 DRUG INTERACTIONS
There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with
other 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, 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.
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
intramuscular route on 4 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.
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11.3 Pediatric Use
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with
orange caps and labels with orange borders for use in individuals 5 through 11 years of age is based on safety
and effectiveness data in this age group and in adolescents and adults.
For adolescents 12 through 17 years of age, a different formulation and a different presentation of this
formulation of the Pfizer-BioNTech COVID-19 Vaccine are authorized.
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals
younger than 5 years of age.
13 DESCRIPTION
The Pfizer-BioNTech COVID-19 Vaccine in multiple dose vials with orange caps and labels with orange
borders is supplied as a frozen suspension; each vial must be diluted with 1.3 mL of sterile 0.9% Sodium
Chloride Injection, USP prior to use to form the vaccine. Each 0.2 mL dose of the Pfizer-BioNTech COVID-19
Vaccine supplied in multiple dose vials with orange caps and labels with orange borders contains 10 mcg of
modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps
and labels with orange borders also includes the following ingredients: lipids (0.14 mg (4-
hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]-
N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol),
10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (sterile 0.9%
Sodium Chloride Injection, USP) contributes 0.9 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
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.
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy of Primary Series 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
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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 (30 mcg modRNA) 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 3 presents
the specific demographic characteristics in the studied population.
Table 3: Demographics (population for the primary efficacy endpoint)a
Pfizer-BioNTech
COVID-19 Vaccine* Placebo
(N=18,242) (N=18,379)
n (%) n (%)
Sex
Male 9318 (51.1) 9225 (50.2)
Female 8924 (48.9) 9154 (49.8)
Age (years)
Mean (SD) 50.6 (15.70) 50.4 (15.81)
Median 52.0 52.0
Min, max (12, 89) (12, 91)
Age group
≥12 through 15 yearsb 46 (0.3) 42 (0.2)
≥16 through 17 years 66 (0.4) 68 (0.4)
≥16 through 64 years 14,216 (77.9) 14,299 (77.8)
≥65 through 74 years 3176 (17.4) 3226 (17.6)
≥75 years 804 (4.4) 812 (4.4)
Race
White 15,110 (82.8) 15,301 (83.3)
Black or African American 1617 (8.9) 1617 (8.8)
American Indian or Alaska Native 118 (0.6) 106 (0.6)
Asian 815 (4.5) 810 (4.4)
Native Hawaiian or other Pacific Islander 48 (0.3) 29 (0.2)
c
Other 534 (2.9) 516 (2.8)
Ethnicity
Hispanic or Latino 4886 (26.8) 4857 (26.4)
Not Hispanic or Latino 13,253 (72.7) 13,412 (73.0)
Not reported 103 (0.6) 110 (0.6)
Comorbiditiesd
Yes 8432 (46.2) 8450 (46.0)
No 9810 (53.8) 9929 (54.0)
* Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
a. All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no other
important protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days
after Dose 2.
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Pfizer-BioNTech
COVID-19 Vaccine* Placebo
(N=18,242) (N=18,379)
n (%) n (%)
b. 100 participants 12 through 15 years of age with limited follow-up in the randomized population received at least 1 dose (49 in
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, and did 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) or
moderate to severe asthma
• Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and
pulmonary 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 been
enrolled 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 4.
Table 4: 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± Placebo
Na=18,198 Na=18,325
Cases Cases
n1 b n1b Vaccine Efficacy %
Subgroup Surveillance Time (n2 ) Surveillance Timec (n2d)
c d (95% CI)
8 162 95.0
All subjectse 2.214 (17,411) 2.222 (17,511) (90.3, 97.6)f
7 143 95.1
16 through 64 years 1.706 (13,549) 1.710 (13,618) (89.6, 98.1)g
1 19 94.7
65 years and older 0.508 (3848) 0.511 (3880) (66.7, 99.9)g
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First 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± Placebo
Na=19,965 Na=20,172
Cases Cases
n1b n1b Vaccine Efficacy %
Subgroup Surveillance Time (n2 ) Surveillance Time (n2 )
c d c d (95% CI)
9 169 94.6
e
All subjects 2.332 (18,559) 2.345 (18,708) (89.9, 97.3)f
8 150 94.6
16 through 64 years 1.802 (14,501) 1.814 (14,627) (89.1, 97.7)g
1 19 94.7
65 years and older 0.530 (4044) 0.532 (4067) (66.8, 99.9)g
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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
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.
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(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.
18.2 Efficacy of Primary Series in Children 5 Through 11 Years of Age
A descriptive efficacy analysis of Study 3 has been performed in 1,968 children 5 through 11 years of age
without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic
COVID-19 cases accrued up to a data cutoff date of October 8, 2021.
Table 5 presents the specific demographic characteristics in participants who did not have evidence of prior
infection with SARS-CoV-2 through 7 days after the second dose.
Table 5: Demographics Characteristics – Participants Without Evidence of Infection Prior to 7 Days
After Dose 2 – Phase 2/3 – 5 Through 11 Years of Age – Evaluable Efficacy Population
Pfizer-BioNTech
COVID-19 Vaccine*
10 mcg/Dose Placebo
(Na=1305) (Na=663)
nb (%) nb (%)
Sex
Male 679 (52.0) 343 (51.7)
Female 626 (48.0) 320 (48.3)
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Pfizer-BioNTech
COVID-19 Vaccine*
10 mcg/Dose Placebo
(Na=1305) (Na=663)
nb (%) nb (%)
Age at Vaccination
Mean (SD) 8.2 (1.93) 8.1 (1.98)
Median 8.0 8.0
Min, max (5, 11) (5, 11)
Race
White 1018 (78.0) 514 (77.5)
Black or African American 76 (5.8) 48 (7.2)
American Indian or Alaska Native <1.0% <1.0%
Asian 86 (6.6) 46 (6.9)
Native Hawaiian or other Pacific Islander <1.0% <1.0%
Otherc 110 (8.4) 52 (7.8)
Ethnicity
Hispanic or Latino 243 (18.6) 130 (19.6)
Not Hispanic or Latino 1059 (81.1) 533 (80.4)
Not reported <1.0% <1.0%
Comorbiditiesd
Yes 262 (20.1) 133 (20.1)
No 1043 (79.9) 530 (79.9)
* Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
a. N = number of participants in the specified group from the evaluable efficacy population with no evidence of SARS CoV-2
infection prior to 7 days after Dose 2. This value is the denominator for the percentage calculations. Evaluable efficacy
population included all eligible randomized participants who received all vaccination(s) as randomized within the predefined
window, had no other important protocol deviations as determined by the clinician.
b. n = Number of participants with the specified characteristic.
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: defined as
participants who had at least 1 of the prespecified comorbidities based on MMWR 69(32);1081-1088 and/or obesity
(BMI ≥ 95th percentile).
The descriptive vaccine efficacy results in children 5 through 11 years of age without evidence of prior
SARS-CoV-2 infection are presented in Table 6. None of the cases accrued met criteria for severe COVID-19
or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either
the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.
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Table 6: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence
of Infection Prior to 7 Days After Dose 2 – Phase 2/3 –Children 5 Through 11 Years of Age
Evaluable Efficacy Population
First COVID-19 occurrence from 7 days after Dose 2 in children 5 through 11 years of age without
evidence of prior SARS-CoV-2 infection*
Pfizer-BioNTech
COVID-19 Vaccine±
10 mcg/dose Placebo
Na=1305 Na=663
Cases Cases
n1b n1b Vaccine Efficacy %
Surveillance Time (n2 ) Surveillance Timec (n2d)
c d (95% CI)
Children 5 through 3 16 90.7
11 years of age 0.322 (1273) 0.159 (637) (67.7, 98.3)
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.
± Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
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.
d. n2 = Number of participants at risk for the endpoint.
18.3 Immunogenicity of Primary Series in Children 5 Through 11 Years of Age
SARS-CoV-2 50% neutralizing antibody titers (NT50) 1 month after the primary series were compared between
randomly selected subsets of Phase 2/3 participants 5 through 11 years of age from study C4591007 and the
efficacy study C4591001 Phase 2/3 participants 16 through 25 years of age, using a microneutralization assay
against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric
mean titers (using a geometric mean ratio [GMR]) and the seroresponse (defined as achieving at least 4-fold rise
in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants
without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 in each group. The prespecified
immunobridging criteria were met for both the GMR and the seroresponse difference (Table 7 and Table 8).
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Table 7: SARS-CoV-2 GMTs (NT50) at 1 Month After Primary Series – Immunobridging Subset -
Participants 5 Through 11 Years of Age (Study 3) and Participants 16 Through 25 Years of
Age (Study 2) – Without Evidence of SARS-CoV-2 Infection up to 1 Month After Dose 2 –
Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19 Vaccine GMT Ratio
10 mcg/Dose* 30 mcg/Dose ±
(95%CI)
5 Through 11 Years of Age 16 Through 25 Years of Age (5 Through 11
na=264 na=253 Years of Age/
Time GMT c GMTc 16 Through 25
Assay Pointb (95% CIc) (95% CIc) Years of Age)d,e
SARS-CoV-2
neutralization 1 month
assay - NT50 after 1197.6 1146.5 1.04
f
(titer) Dose 2 (1106.1, 1296.6) (1045.5, 1257.2) (0.93, 1.18)
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of
quantitation; 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 post-Dose 2 blood sample collection) of past
SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at pre-Dose 1 and 1 month after Dose 2, SARS-CoV-2 not
detected by NAAT [nasal swab] at pre-Dose 1 and pre-Dose 2, and negative NAAT (nasal swab) at any unscheduled visit up to 1
month after Dose 2 blood collection) and had no medical history of COVID-19 were included in the analysis.
* Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
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. GMT ratio and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1
[5 through 11 years of age] - Group 2 [16 through 25 years of age]) and the corresponding CI (based on the Student t
distribution).
e. Immunobridging is declared if the lower bound of the 2-sided 95% CI for the GMT ratio is greater than 0.67 and the point
estimate of the GMR is ≥0.8.
f. SARS-CoV-2 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.
Table 8: Percentages of Participants with Seroresponse at 1 Month After Primary Series –
Immunobridging Subset –Participants 5 Through 11 Years of Age (Study 3) and Participants
16 Through 25 Years of Age (Study 2) Without Evidence of Infection up to 1 Month After Dose
2 – Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19 Vaccine Difference in
10 mcg/Dose* 30 mcg/Dose± Seroresponse
5 Through 11 Years of Age 16 Through 25 Years of Age Rates %e (95%
Na=264 Na=253 CIf)
(5 Through 11
Years of Age
Time n (%)
c n (%)
c minus 16 Through
Assay Pointb (95% CId) (95% CId) 25 Years of Age)g
SARS-CoV-2
neutralization 1 month
assay - NT50 after 262 (99.2) 251 (99.2) 0.0
h
(titer) Dose 2 (97.3, 99.9) (97.2, 99.9) (-2.0, 2.2)
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Abbreviations: LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2
nucleoprotein–binding; NT50 = 50% neutralizing titer 50; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Note: Seroresponse is defined as achieving a ≥4-fold rise from baseline (before Dose 1). If the baseline measurement is below the
LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponse
Note: Participants who had no serological or virological evidence (up to 1 month post-Dose 2 blood sample collection) of past SARS-
CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and 1 month after Dose 2, SARS-CoV-2 not detected by NAAT
[nasal swab] at Visits 1 and 2, and negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 blood collection)
and had no medical history of COVID-19 were included in the analysis.
* Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
a. N = number of participants with valid and determinate assay results both before vaccination and at 1 month after Dose 2. These
values are the denominators for the percentage calculations.
b. Protocol-specified timing for blood sample collection.
c. n = Number of participants with seroresponse for the given assay at the given dose/sampling time point.
d. Exact 2-sided CI based on the Clopper and Pearson method.
e. Difference in proportions, expressed as a percentage (Group 1 [5 through 11 years of age] – Group 2 [16 through 25 years of
age]).
f. 2-Sided CI, based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
g. Immunobridging is declared if the lower bound of the 2-sided 95% CI for the difference in proportions is greater than -10.0%.
h. SARS-CoV-2 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
The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple
dose vials with orange caps and labels with orange borders. These multiple dose vials are supplied in a carton
containing 10 multiple dose vials (NDC 59267-1055-4). After dilution, 1 vial contains 10 doses of 0.2 mL.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Vial Storage Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange
borders may arrive frozen at ultra-cold conditions in thermal containers with dry ice or at -25°C to -15°C (-13°F
to 5°F).
Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)],
thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at
the time of transfer. A carton of 10 vials may take up to 4 hours to thaw at this temperature.
Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF).
Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen.
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange
borders may also arrive at 2°C to 8°C. If received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that
the carton has been updated to reflect the 10-week refrigerated expiry date.
Regardless of storage condition, vaccines should not be used after 6 months from the date of manufacture
printed on the vial and cartons.
Revised: 29 October 2021 41
Case 2:21-cv-00702-CLM Document 40-5 Filed 12/17/21 Page 43 of 44
Vial Storage During Use
If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC
(77ºF)] for 30 minutes.
Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may
be stored at 8°C to 25°C (46°F to 77°F) for a total of 12 hours prior to dilution. After dilution, the vial should be
held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution.
Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information
in this Full EUA Prescribing Information supersedes the number of hours printed on vial labels and cartons.
Transportation of Vials
If local redistribution is needed, undiluted vials may be transported at -90°C to -60°C (-130°F to -76°F) or at
2°C to 8°C (35°F to 46°F).
20 PATIENT COUNSELING INFORMATION
Advise the recipient or caregiver to read the Vaccine Information 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.
Website Telephone number
www.cvdvaccine.com
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
Revised: 29 October 2021 42
Case 2:21-cv-00702-CLM Document 40-5 Filed 12/17/21 Page 44 of 44
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1503-0.4
Revised: 29 October 2021
Revised: 29 October 2021 43
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