Burk Declaration
- Date
- 2021-12-17
Summary
Document 40-4, filed December 17, 2021 in Case 2:21-cv-00702-CLM in the U.S. District Court, N.D. of Alabama, is Burk Declaration Exhibit 4: the FDA Fact Sheet for Healthcare Providers Administering Vaccine for the Pfizer-BioNTech COVID-19 Vaccine for 12 years of age and older, revised 29 October 2021. The fact sheet covers the formulation in a multiple dose vial with a gray cap that must not be diluted. It describes authorized uses including a 2-dose primary series, a third primary series dose for certain immunocompromised individuals and a single booster dose, and states that COMIRNATY is FDA-approved for individuals 16 years of age and older. It sets out storage, thawing, preparation and administration instructions, with each vial containing 6 doses of 0.3 mL. The 52-page exhibit closes with patient counseling and contact information.
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Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 1 of 52 FILED
2021 Dec-17 PM 01:27
U.S. DISTRICT COURT
N.D. OF ALABAMA
Burk Declaration
Exhibit 4
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 2 of 52
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 12 YEARS OF AGE AND OLDER
DO NOT DILUTE
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.
There are 2 formulations of Pfizer-BioNTech COVID-19 Vaccine authorized for
use in individuals 12 years of age and older:
The formulation supplied in a multiple dose vial with a gray cap and
label with a gray border IS NOT DILUTED PRIOR TO USE.
The formulation supplied in a multiple dose vial with a purple cap
MUST BE DILUTED PRIOR TO USE.
This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied
in a multiple dose vial with a gray cap and a label with a gray border which is
authorized for use in individuals 12 years of age and older and MUST NOT BE
DILUTED PRIOR TO USE.
Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a
gray cap and a label with a gray border is authorized for use to provide:
• a 2-dose primary series to individuals 12 years of age and older;
• a third primary series dose to individuals 12 years of age and older
who have been determined to have certain kinds of
immunocompromise; and
• a single booster dose to the following individuals who have completed
a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY:
o 65 years of age and older
o 18 through 64 years of age at high risk of severe COVID-19
o 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
• a single booster dose to eligible individuals who have completed
primary vaccination with a different authorized COVID-19 vaccine. The
eligible population(s) and dosing interval for the heterologous booster
Revised: 29 October 2021 1
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dose are the same as those authorized for a booster dose of the
vaccine used for primary vaccination.
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19
vaccine made by Pfizer for BioNTech that is indicated for active immunization
to prevent COVID-19 in individuals 16 years of age and older. It is approved
for use as a 2-dose primary series for the prevention of COVID-19 in
individuals 16 years of age and older. It is also authorized for emergency use
to provide:
• a 2-dose primary series to individuals 12 through 15 years;
• a third primary series dose to individuals 12 years of age and older
who have been determined to have certain kinds of
immunocompromise; and
• a single booster dose to the following individuals who have completed
a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY:
o 65 years of age and older
o 18 through 64 years of age at high risk of severe COVID-19
o 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
• a single booster dose to eligible individuals who have completed
primary vaccination with a different authorized COVID-19 vaccine. The
eligible population(s) and dosing interval for the heterologous booster
dose are the same as those authorized for a booster dose of the
vaccine used for primary vaccination.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the two
EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages
12 years and older when prepared according to their respective instructions
for use can be used interchangeably. 1
COMIRNATY (COVID-19 Vaccine, mRNA) and the two EUA-authorized
formulations of Pfizer-BioNTech COVID-19 Vaccine intended for individuals
ages 12 years and older should not be used for individuals 5 through
11 years of age because of the potential for vaccine administration errors,
including dosing errors. 2
1
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY
(COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19
Vaccine for ages 12 years of age and older can be used interchangeably without presenting any safety or
effectiveness concerns.
2
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 2
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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.
Primary Series:
The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of
2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older.
A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at
least 28 days following the second dose is authorized for administration to
individuals at least 12 years of age who have undergone solid organ
transplantation, or who are diagnosed with conditions that are considered to have
an equivalent level of immunocompromise.
Booster Dose:
A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be
administered intramuscularly at least 6 months after completing the primary series
to individuals:
• 65 years of age and older
• 18 through 64 years of age at high risk of severe COVID-19
• 18 through 64 years of age with frequent institutional or occupational
exposure to SARS-CoV-2
A single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be
administered as a heterologous booster dose following completion of primary
vaccination with another authorized COVID-19 vaccine. The eligible population(s)
and dosing interval for the heterologous booster dose are the same as those
authorized for a booster dose of the vaccine used for primary vaccination.
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.
Revised: 29 October 2021 3
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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 for 12 years of age and older, which is
supplied in a multiple dose vial with a gray cap and a label with a gray border and
MUST NOT be diluted prior to use.
Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Gray Cap and a
Label with a Gray Border
Dilution
Age Range Information Doses Per Vial Dose Volume
12 years and Do not dilute prior to
6 0.3 mL
older 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.
Vial Storage Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps
and labels with gray 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 6 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.
Revised: 29 October 2021 4
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Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps
and labels with gray 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 gray caps and labels
with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)]
for a total of 12 hours prior to the first puncture. After first puncture, the vial should
be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours
after first puncture.
DO NOT DILUTE PRIOR TO USE.
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, vials may be transported at -90°C to -60°C (-130°F
to -76°F) or 2°C to 8°C (35°F to 46°F).
Dosing and Schedule
Primary Series
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a
primary series of 2 doses (0.3 mL each) 3 weeks apart to individuals 12 years of
age and older.
A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at
least 28 days following the second dose is authorized for administration to
individuals at least 12 years of age who have undergone solid organ
transplantation, or who are diagnosed with conditions that are considered to have
an equivalent level of immunocompromise.
Revised: 29 October 2021 5
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Booster Dose:
A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be
administered intramuscularly at least 6 months after completing the primary series
to individuals:
• 65 years of age and older
• 18 through 64 years of age at high risk of severe COVID-19
• 18 through 64 years of age with frequent institutional or occupational
exposure to SARS-CoV-2
A single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be
administered as a heterologous booster dose following completion of primary
vaccination with another authorized COVID-19 vaccine. The eligible population(s)
and dosing interval for the heterologous booster dose are the same as those
authorized for a booster dose of the vaccine used for primary vaccination.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the two
EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12
years and older when prepared according to their respective instructions for use,
can be used interchangeably.
COMIRNATY (COVID-19 Vaccine, mRNA) and the two EUA-authorized
formulations of Pfizer-BioNTech COVID-19 Vaccine intended for individuals ages
12 years and older 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
DO NOT DILUTE
• The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a gray cap
and a label with a gray border contains a volume of 2.25 mL, and is supplied
as a frozen suspension that does not contain preservative. Each vial must
be thawed prior to administration. DO NOT DILUTE prior to use.
• 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.
• One vial contains 6 doses of 0.3 mL.
Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray
Border –
Vial Verification
Verify that the vial of
Pfizer-BioNTech COVID-19 Vaccine
has a gray plastic cap and a label
with gray border.
Revised: 29 October 2021 6
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Preparation Instructions
Gray plastic cap and label with
gray border.
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray
Border –
Thawing Prior to Use
• 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
Store in the may take up to 6 hours to
refrigerator for thaw, and thawed vials can be
up to 10 weeks stored in the refrigerator for up
prior to use. to 10 weeks.
o Allowing vial(s) to sit at room
temperature [up to 25ºC
(77ºF)] for 30 minutes.
• Vials may be stored at room
temperature [up to 25ºC (77ºF)]
for up to 12 hours prior to use.
Revised: 29 October 2021 7
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Preparation Instructions
• Before use, mix by inverting
vaccine vial gently 10 times.
• Do not shake.
• Prior to mixing, the thawed
vaccine may contain white to
off-white opaque amorphous
particles.
• After mixing, the vaccine should
appear as a white to off-white
suspension with no visible
particles.
• Do not use if liquid is discolored
or if particles are observed after
mixing.
Gently × 10
Revised: 29 October 2021 8
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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 0.3 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.
Vials of Pfizer-BioNTech COVID-19 Vaccine with gray caps and labels with gray
borders contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or
needles can be used to extract 6 doses from a single vial. If standard syringes and
needles are used, there may not be sufficient volume to extract 6 doses from a
single vial. Irrespective of 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 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
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
Revised: 29 October 2021 10
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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.
Adverse Reactions
Adverse Reactions in Clinical Trials
Adverse reactions following administration of the Pfizer-BioNTech COVID-19
Vaccine that have been reported in clinical trials include injection site pain, fatigue,
headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site
redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in
extremity (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, 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.
Revised: 29 October 2021 11
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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 the 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 the
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 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.
Revised: 29 October 2021 12
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MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION 3
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.
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.
3 Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the
same reporting requirements.
Revised: 29 October 2021 13
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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.
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
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
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved vaccine to prevent
COVID-19 caused by SARS-CoV-2. There may be clinical trials or availability under
EUA of other COVID-19 vaccines.
Revised: 29 October 2021 14
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COMIRNATY (COVID-19 Vaccine, mRNA) and the two EUA-authorized
formulations of Pfizer-BioNTech COVID-19 Vaccine intended for individuals ages
12 years and older should not be used for individuals 5 through 11 years of age
because of the potential for administration errors, including dosing errors.
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, and for certain uses of
FDA-approved COMIRNATY for active immunization against COVID-19.
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 and COMIRNATY (COVID-19
Vaccine, mRNA) 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 and COMIRNATY
(COVID-19 Vaccine, mRNA) 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.
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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-1484-0.3
Revised: 29 October 2021
END SHORT VERSION FACT SHEET
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
11.2 Lactation
11.3 Pediatric Use
FULL EMERGENCY USE AUTHORIZATION
11.4 Geriatric Use
PRESCRIBING INFORMATION: CONTENTS* 11.5 Use in Immunocompromised
13 DESCRIPTION
1 AUTHORIZED USE 14 CLINICAL PHARMACOLOGY
2 DOSAGE AND ADMINISTRATION 14.1 Mechanism of Action
2.1 Preparation for Administration 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR
2.2 Administration Information EUA
2.3 Vaccination Schedule 18.1 Efficacy of Primary Series in Participants 16 Years of Age and
3 DOSAGE FORMS AND STRENGTHS Older
4 CONTRAINDICATIONS 18.2 Efficacy of Primary Series in Adolescents 12 Through 15 Years of
5 WARNINGS AND PRECAUTIONS Age
5.1 Management of Acute Allergic Reactions 18.3 Immunogenicity of Primary Series in Adolescents 12 Through
5.2 Myocarditis and Pericarditis 15 Years of Age
5.3 Syncope 18.4 Immunogenicity of a Booster Dose Following a Pfizer-BioNTech
5.4 Altered Immunocompetence COVID-19 Vaccine Primary Series in Participants 18 Through
5.5 Limitation of Effectiveness 55 Years of Age
6 OVERALL SAFETY SUMMARY 18.5 Immunogenicity in Solid Organ Transplant Recipients
6.1 Clinical Trials Experience 18.6 Immunogenicity of a Booster Dose Following Primary Vaccination
6.2 Post Authorization Experience with Another Authorized COVID-19 Vaccine
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING 19 HOW SUPPLIED/STORAGE AND HANDLING
ADVERSE EVENTS AND VACCINE ADMINISTRATION 20 PATIENT COUNSELING INFORMATION
ERRORS 21 CONTACT INFORMATION
10 DRUG INTERACTIONS
11 USE IN SPECIFIC POPULATIONS * Sections or subsections omitted from the full emergency use authorization
11.1 Pregnancy prescribing information are not listed.
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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 Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose
vial with a gray cap and label with a gray border, which is authorized for use in individuals 12 years of age and
older.
2 DOSAGE AND ADMINISTRATION
For intramuscular injection only.
The storage, preparation, and administration information in this Prescribing Information apply to the
Pfizer-BioNTech COVID-19 Vaccine for 12 years of age and older, which is supplied in a multiple dose vial
with a gray cap and label with a gray border and MUST NOT be diluted prior to use.
Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Gray Cap and a Label with a Gray Border
Age Range Dilution Information Doses Per Vial Dose Volume
12 years and older Do not dilute prior to use 6 0.3 mL
2.1 Preparation for Administration
DO NOT DILUTE
• The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a gray cap and a label with a gray
border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain
preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
• 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.
• One vial contains 6 doses of 0.3 mL.
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Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border –
Vial Verification
• Verify that the vial of Pfizer-BioNTech
COVID-19 Vaccine has a gray plastic cap
and a label with a gray border.
Gray plastic cap and label with gray border.
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border –
Thawing Prior to Use
• Thaw vial(s) of Pfizer-BioNTech COVID-19
Vaccine (Do Not Dilute, for 12 years of age
and older) before use either by:
o Allowing vial(s) to thaw in the refrigerator
Store in the [2ºC to 8ºC (35ºF to 46ºF)]. A carton of
refrigerator for 10 vials may take up to 6 hours to thaw,
up to 10 weeks and 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.
• Vials may be stored at room temperature [up
to 25ºC (77ºF)] for up to 12 hours prior to
use.
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Preparation Instructions
• Before use, mix by inverting vaccine vial
gently 10 times.
• Do not shake.
• Prior to mixing, the thawed vaccine may
contain white to off-white opaque amorphous
particles.
• After mixing, the vaccine should appear as a
white to off-white suspension with no visible
particles.
• Do not use if liquid is discolored or if
particles are observed after mixing.
Gently × 10
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border –
Preparation of Individual 0.3 mL Doses
• Using aseptic technique, cleanse the vial
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 of vaccine.
• 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.
Withdraw 0.3 mL dose of vaccine.
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2.3 Vaccination Schedule
Primary Series
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses
(0.3 mL each) 3 weeks apart in individuals 12 years of age and older.
A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the
second dose is authorized for administration to individuals at least 12 years of age who have undergone solid
organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of
immunocompromise.
Booster Dose
A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered intramuscularly at
least 6 months after completing the primary series to individuals:
• 65 years of age and older
• 18 through 64 years of age at high risk of severe COVID-19
• 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
A single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered as a heterologous
booster dose following completion of primary vaccination with another authorized COVID-19 vaccine. The
eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for
a booster dose of the vaccine used for primary vaccination.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of
Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older when prepared according to their respective
instructions for use, can be used interchangeably.
COMIRNATY (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech
COVID-19 Vaccine intended for individuals ages 12 years and older should not be used for individuals
5 through 11 years of age because of the potential for vaccine administration errors, including dosing errors.
3 DOSAGE FORMS AND STRENGTHS
Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with gray caps and labels with gray
borders is 0.3 mL for individuals 12 years of age and older [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)].
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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.
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. 5 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.
5
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
Revised: 29 October 2021 23
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Primary Series
In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine
containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of
SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included
pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint
pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%),
malaise (0.5%), and lymphadenopathy (0.3%).
In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine
(30 mcg modRNA), adverse reactions following administration of the primary series 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%).
Booster Dose
In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a
booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%),
chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash
(0.3%), and pain in extremity (0.3%).
Post Authorization Experience
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.
Primary Series
The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of
age and older in 2 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) encoding
the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older
Revised: 29 October 2021 24
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(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).
In Study 2, all participants 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 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 (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.
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 for
swelling 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.
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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 of
Age‡ – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
N =2291
a N =2298
a N =2098
a Na=2103
n (%)
b n (%)
b n (%)
b nb (%)
Rednessc
Any (>2 cm) 104 (4.5) 26 (1.1) 123 (5.9) 14 (0.7)
Mild 70 (3.1) 16 (0.7) 73 (3.5) 8 (0.4)
Moderate 28 (1.2) 6 (0.3) 40 (1.9) 6 (0.3)
Severe 6 (0.3) 4 (0.2) 10 (0.5) 0 (0.0)
c
Swelling
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)
Severe 5 (0.2) 3 (0.1) 7 (0.3) 0 (0.0)
d
Pain at the injection site
Any 1904 (83.1) 322 (14.0) 1632 (77.8) 245 (11.7)
Mild 1170 (51.1) 308 (13.4) 1039 (49.5) 225 (10.7)
Moderate 710 (31.0) 12 (0.5) 568 (27.1) 20 (1.0)
Severe 24 (1.0) 2 (0.1) 25 (1.2) 0 (0.0)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
b. n = Number of participants with the specified reaction.
c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
‡ Eight participants were between 16 and 17 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
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 of
Age‡ – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
N =2291
a N =2298
a N =2098
a Na=2103
n (%)
b n (%)
b n (%)
b 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)
Fatiguec
Any 1085 (47.4) 767 (33.4) 1247 (59.4) 479 (22.8)
Mild 597 (26.1) 467 (20.3) 442 (21.1) 248 (11.8)
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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=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Moderate 455 (19.9) 289 (12.6) 708 (33.7) 217 (10.3)
Severe 33 (1.4) 11 (0.5) 97 (4.6) 14 (0.7)
Headachec
Any 959 (41.9) 775 (33.7) 1085 (51.7) 506 (24.1)
Mild 628 (27.4) 505 (22.0) 538 (25.6) 321 (15.3)
Moderate 308 (13.4) 251 (10.9) 480 (22.9) 170 (8.1)
Severe 23 (1.0) 19 (0.8) 67 (3.2) 15 (0.7)
c
Chills
Any 321 (14.0) 146 (6.4) 737 (35.1) 79 (3.8)
Mild 230 (10.0) 111 (4.8) 359 (17.1) 65 (3.1)
Moderate 82 (3.6) 33 (1.4) 333 (15.9) 14 (0.7)
Severe 9 (0.4) 2 (0.1) 45 (2.1) 0 (0.0)
Vomitingd
Any 28 (1.2) 28 (1.2) 40 (1.9) 25 (1.2)
Mild 24 (1.0) 22 (1.0) 28 (1.3) 16 (0.8)
Moderate 4 (0.2) 5 (0.2) 8 (0.4) 9 (0.4)
Severe 0 (0.0) 1 (0.0) 4 (0.2) 0 (0.0)
Diarrheae
Any 255 (11.1) 270 (11.7) 219 (10.4) 177 (8.4)
Mild 206 (9.0) 217 (9.4) 179 (8.5) 144 (6.8)
Moderate 46 (2.0) 52 (2.3) 36 (1.7) 32 (1.5)
Severe 3 (0.1) 1 (0.0) 4 (0.2) 1 (0.0)
New or worsened
muscle painc
Any 487 (21.3) 249 (10.8) 783 (37.3) 173 (8.2)
Mild 256 (11.2) 175 (7.6) 326 (15.5) 111 (5.3)
Moderate 218 (9.5) 72 (3.1) 410 (19.5) 59 (2.8)
Severe 13 (0.6) 2 (0.1) 47 (2.2) 3 (0.1)
New or worsened
joint painc
Any 251 (11.0) 138 (6.0) 459 (21.9) 109 (5.2)
Mild 147 (6.4) 95 (4.1) 205 (9.8) 54 (2.6)
Moderate 99 (4.3) 43 (1.9) 234 (11.2) 51 (2.4)
Severe 5 (0.2) 0 (0.0) 20 (1.0) 4 (0.2)
Use of antipyretic or
pain medicationf 638 (27.8) 332 (14.4) 945 (45.0) 266 (12.6)
Revised: 29 October 2021 27
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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=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1802 Na=1792 Na=1660 Na=1646
nb (%) nb (%) nb (%) nb (%)
c
Redness
Any (>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)
Severe 3 (0.2) 2 (0.1) 8 (0.5) 1 (0.1)
Swellingc
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)
Severe 2 (0.1) 0 (0.0) 3 (0.2) 1 (0.1)
Pain at the injection
sited
Any (>2 cm) 1282 (71.1) 166 (9.3) 1098 (66.1) 127 (7.7)
Mild 1008 (55.9) 160 (8.9) 792 (47.7) 125 (7.6)
Moderate 270 (15.0) 6 (0.3) 298 (18.0) 2 (0.1)
Severe 4 (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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
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Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
N =1802
a N =1792
a N =1660
a Na=1646
n (%)
b n (%)
b n (%)
b 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)
Fatiguec
Any 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)
Severe 2 (0.1) 3 (0.2) 46 (2.8) 2 (0.1)
Headachec
Any 454 (25.2) 325 (18.1) 647 (39.0) 229 (13.9)
Mild 348 (19.3) 242 (13.5) 422 (25.4) 165 (10.0)
Moderate 104 (5.8) 80 (4.5) 216 (13.0) 60 (3.6)
Severe 2 (0.1) 3 (0.2) 9 (0.5) 4 (0.2)
Chillsc
Any 113 (6.3) 57 (3.2) 377 (22.7) 46 (2.8)
Mild 87 (4.8) 40 (2.2) 199 (12.0) 35 (2.1)
Moderate 26 (1.4) 16 (0.9) 161 (9.7) 11 (0.7)
Severe 0 (0.0) 1 (0.1) 17 (1.0) 0 (0.0)
d
Vomiting
Any 9 (0.5) 9 (0.5) 11 (0.7) 5 (0.3)
Mild 8 (0.4) 9 (0.5) 9 (0.5) 5 (0.3)
Moderate 1 (0.1) 0 (0.0) 1 (0.1) 0 (0.0)
Severe 0 (0.0) 0 (0.0) 1 (0.1) 0 (0.0)
e
Diarrhea
Any 147 (8.2) 118 (6.6) 137 (8.3) 99 (6.0)
Mild 118 (6.5) 100 (5.6) 114 (6.9) 73 (4.4)
Moderate 26 (1.4) 17 (0.9) 21 (1.3) 22 (1.3)
Severe 3 (0.2) 1 (0.1) 2 (0.1) 4 (0.2)
New or worsened
muscle painc
Any 251 (13.9) 149 (8.3) 477 (28.7) 87 (5.3)
Mild 168 (9.3) 100 (5.6) 202 (12.2) 57 (3.5)
Moderate 82 (4.6) 46 (2.6) 259 (15.6) 29 (1.8)
Severe 1 (0.1) 3 (0.2) 16 (1.0) 1 (0.1)
New or worsened joint
painc
Revised: 29 October 2021 29
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 31 of 52
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1802 Na=1792 Na=1660 Na=1646
nb (%) nb (%) nb (%) nb (%)
Any 155 (8.6) 109 (6.1) 313 (18.9) 61 (3.7)
Mild 101 (5.6) 68 (3.8) 161 (9.7) 35 (2.1)
Moderate 52 (2.9) 40 (2.2) 145 (8.7) 25 (1.5)
Severe 2 (0.1) 1 (0.1) 7 (0.4) 1 (0.1)
Use of antipyretic or
pain medication 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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19
vaccine in solid-organ transplant recipients. N Engl J Med), in 99 individuals who had undergone various solid
organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third
vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4
events were reported in recipients who were followed for 1 month following post Dose 3.
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
Revised: 29 October 2021 30
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 32 of 52
Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who
received at least 1 dose. Overall in a similar analysis in which 7960 participants 56 years of age and older
received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in
23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the
placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had
at least 30 days of follow-up after Dose 2.
The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19
Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events
reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among
participants in the reactogenicity subset and presented in Tables 3 and 4. From Dose 1 through 30 days after
Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech
COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Throughout
the safety follow-up period to date, Bell’s palsy (facial paralysis) was reported by 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.
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.
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.
Revised: 29 October 2021 31
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 33 of 52
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 2
N =1127
a N =1127
a N =1097
a Na=1078
n (%)
b n (%)
b n (%)
b 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)
Severe 1 (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)
Severe 0 (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)
Severe 11 (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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
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 1 Dose 2 Dose 2
Na=1127 Na=1127 Na=1097 Na=1078
nb (%) 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
Fatigue
Any 677 (60.1) 457 (40.6) 726 (66.2) 264 (24.5)
Revised: 29 October 2021 32
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 34 of 52
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1127 Na=1127 Na=1097 Na=1078
nb (%) nb (%) nb (%) nb (%)
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)
Severe 15 (1.3) 8 (0.7) 26 (2.4) 4 (0.4)
Headachec
Any 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)
Severe 11 (1.0) 9 (0.8) 22 (2.0) 1 (0.1)
Chillsc
Any 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)
Severe 5 (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)
Severe 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
Diarrheae
Any 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)
Severe 0 (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)
Severe 2 (0.2) 0 (0.0) 6 (0.5) 2 (0.2)
New or worsened joint
painc
Any 109 (9.7) 77 (6.8) 173 (15.8) 51 (4.7)
Mild 66 (5.9) 50 (4.4) 91 (8.3) 30 (2.8)
Moderate 42 (3.7) 27 (2.4) 78 (7.1) 21 (1.9)
Severe 1 (0.1) 0 (0.0) 4 (0.4) 0 (0.0)
Revised: 29 October 2021 33
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 35 of 52
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine± Placebo COVID-19 Vaccine± Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=1127 Na=1127 Na=1097 Na=1078
nb (%) nb (%) nb (%) nb (%)
Use of antipyretic or
pain medicationf 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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
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.
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.
Booster Dose Following a Primary Series of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY
A subset of Study 2 Phase 2/3 participants of 306 adults 18 through 55 years of age received a booster dose of
Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) approximately 6 months (range of 4.8 to 8.0 months)
after completing the primary series. Additionally, a total of 23 Study 2 Phase 1 participants (11 participants 18
through 55 years of age and 12 participants 65 through 85 years of age) received a booster dose of
Pfizer-BioNTech COVID-19 Vaccine approximately 8 months (range 7.9 to 8.8 months) after completing the
primary series. Safety monitoring after the booster dose was the same as that in the reactogenicity subset who
received the primary series.
Among the 306 Phase 2/3 participants, the median age was 42 years (range 19 through 55 years of age), 45.8%
were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or
Revised: 29 October 2021 34
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 36 of 52
African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native. Among the 12 Phase 1
participants 65 through 85 years of age, the median age was 69 years (range 65 through 75 years of age), 6 were
male and all were White and Not Hispanic/Latino. Following the booster dose, the median follow-up time was
2.6 months (range 2.1 to 2.9 months) for Phase 1 participants and 2.6 months (range 1.1 to 2.8 months) for
Phase 2/3 participants.
Solicited Local and Systemic Adverse Reactions
Table 7 and Table 8 present the frequency and severity of reported solicited local and systemic reactions,
respectively, within 7 days of a booster dose of Pfizer-BioNTech COVID-19 Vaccine for Phase 2/3 participants
18 through 55 years of age.
In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose
was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to
8 days).
Table 7: Study 2 – Frequency and Percentages of Participants With Solicited Local Reactions, By
Maximum Severity, Within 7 Days After the Booster Dose of Pfizer-BioNTech COVID-19
Vaccine – Participants 18 through 55 Years of Age*
Pfizer-BioNTech COVID-19 Vaccine±
Booster Dose
Na = 289
Solicited Local Reaction nb (%)
Rednessc
Any (>2 cm) 17 (5.9)
Mild 10 (3.5)
Moderate 7 (2.4)
Severe 0
c
Swelling
Any (>2 cm) 23 (8.0)
Mild 13 (4.5)
Moderate 9 (3.1)
Severe 1 (0.3)
Pain at the injection sited
Any 240 (83.0)
Mild 174 (60.2)
Moderate 65 (22.5)
Severe 1 (0.3)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after the booster dose.
Note: No Grade 4 solicited local reactions were reported.
* A subset of Phase 2/3 participants 18 through 55 years of age who received a booster dose of COMIRNATY (COVID-19
Vaccine, mRNA) approximately 6 months after completing the primary series.
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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
Revised: 29 October 2021 35
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 37 of 52
Table 8: Study 2 – Frequency and Percentages of Participants With Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After the Booster Dose of Pfizer-BioNTech COVID-19
Vaccine – Participants 18 through 55 Years of Age*
Pfizer-BioNTech COVID-19 Vaccine±
Booster Dose
Na = 289
Solicited Systemic Reaction nb (%)
Fever
≥38.0℃ 25 (8.7)
≥38.0℃ to 38.4℃ 12 (4.2)
>38.4℃ to 38.9℃ 12 (4.2)
>38.9℃ to 40.0℃ 1 (0.3)
>40.0℃ 0
c
Fatigue
Any 184 (63.7)
Mild 68 (23.5)
Moderate 103 (35.6)
Severe 13 (4.5)
c
Headache
Any 140 (48.4)
Mild 83 (28.7)
Moderate 54 (18.7)
Severe 3 (1.0)
c
Chills
Any 84 (29.1)
Mild 37 (12.8)
Moderate 44 (15.2)
Severe 3 (1.0)
d
Vomiting
Any 5 (1.7)
Mild 5 (1.7)
Moderate 0
Severe 0
Diarrheae
Any 25 (8.7)
Mild 21 (7.3)
Moderate 4 (1.4)
Severe 0
New or worsened muscle painc
Any 113 (39.1)
Mild 52 (18.0)
Moderate 57 (19.7)
Severe 4 (1.4)
Revised: 29 October 2021 36
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 38 of 52
Pfizer-BioNTech COVID-19 Vaccine±
Booster Dose
Na = 289
Solicited Systemic Reaction nb (%)
New or worsened joint painc
Any 73 (25.3)
Mild 36 (12.5)
Moderate 36 (12.5)
Severe 1 (0.3)
Use of antipyretic or pain medicationf 135 (46.7)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after
the booster dose.
Note: No Grade 4 solicited systemic reactions were reported.
* A subset of Phase 2/3 participants 18 through 55 years of age who received a booster dose of COMIRNATY (COVID-19
Vaccine, mRNA) approximately 6 months after completing the primary series.
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.
± Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
In Phase 1 participants ≥65 years of age (n = 12), local reaction pain at the injection site (n = 8, 66.7%) and
systemic reactions fatigue (n = 5, 41.7%), headache (n = 5, 41.7%), chills (n = 2, 16.7%), muscle pain (n = 4,
33.3%), and joint pain (n = 2, 16.7%) were reported after the booster dose. No participant in this age group
reported a severe systemic event or fever after the booster dose.
Unsolicited Adverse Events
Overall, the 306 participants who received a booster dose, had a median follow-up time of 2.6 months after the
booster dose to the cut-off date (June 17, 2021).
In an analysis of all unsolicited adverse events reported following the booster dose, through 1 month after the
booster dose, in participants 18 through 55 years of age (N = 306), those assessed as adverse reactions not
already captured by solicited local and systemic reactions were lymphadenopathy (n = 16, 5.2%), nausea (n = 2,
0.7%), decreased appetite (n = 1, 0.3%), rash (n = 1, 0.3%), and pain in extremity (n = 1, 0.3%).
Serious Adverse Events
Of the 306 participants who received a booster dose of Pfizer-BioNTech COVID-19 Vaccine, there were no
serious adverse events reported from the booster dose through 30 days after the booster dose. One participant
reported a serious adverse event 61 days after the booster dose that was assessed as unrelated to vaccination.
Booster Dose Following Primary Vaccination with Another Authorized COVID-19 Vaccine
The safety of a Pfizer-BioNTech COVID-19 Vaccine booster dose (30 mcg modRNA) in individuals who
completed primary vaccination with another authorized COVID-19 Vaccine (heterologous booster dose) is
inferred from the safety of a Pfizer-BioNTech COVID-19 Vaccine booster dose administered following
completion of Pfizer-BioNTech COVID-19 Vaccine primary series (homologous booster dose) and from data
from an independent National Institutes of Health (NIH) study Phase 1/2 open-label clinical trial
(NCT04889209) conducted in the United States that evaluated a heterologous booster dose of the Pfizer-
Revised: 29 October 2021 37
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BioNTech COVID-19 Vaccine. In this study, adults who had completed primary vaccination with a Moderna
COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-
BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who reported no
history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of three vaccines:
Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine (30 mcg
modRNA). Adverse events were assessed through 28 days after the booster dose. An overall review of adverse
reactions reported in the study following the Pfizer-BioNTech COVID-19 Vaccine heterologous booster dose
did not identify any new safety concerns, as compared with adverse reactions reported following a Pfizer-
BioNTech COVID-19 Vaccine primary series doses or homologous booster dose.
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 6
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 individual
and may require medical or surgical intervention to prevent 1 of the outcomes listed above
6
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
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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.
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.
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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.
11.3 Pediatric Use
Emergency Use Authorization of this formulation of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple
dose vials with gray caps and labels with gray borders, in adolescents 12 through 17 years of age is based on
safety and effectiveness data in this age group and in adults.
For individuals 5 through 11 years of age, a different presentation of this formulation of the Pfizer-BioNTech
COVID-19 Vaccine is authorized.
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Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals
younger than 5 years of age.
11.4 Geriatric Use
Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older who
received the primary series and their data contributes to the overall assessment of safety and efficacy [see
Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. Of the total
number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were
65 years of age and older and 4.3% (n=860) were 75 years of age and older.
The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine in individuals 65 years of age and older is
based on safety data in 12 booster dose recipients 65 through 85 years of age and 306 booster dose recipients 18
through 55 years of age in Study 2. The effectiveness of a booster dose of Pfizer-BioNTech COVID-19 Vaccine
in individuals 65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through
55 years of age in Study 2.
11.5 Use in Immunocompromised
From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19
vaccine in solid-organ transplant recipients. N Engl J Med), safety and effectiveness of a third dose of the
Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. The
administration of a third dose of vaccine appears to be only moderately effective in increasing potentially
protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent
COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for
their health status.
13 DESCRIPTION
The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials with gray
caps and labels with gray borders. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in
multiple dose vials with gray caps and labels with gray borders contains 30 mcg of a nucleoside-modified
messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with gray caps
and labels with gray borders 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 0.19 mg cholesterol),
0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.
The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with
natural rubber latex.
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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
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 9 presents
the specific demographic characteristics in the studied population.
Table 9: 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)
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Pfizer-BioNTech
COVID-19 Vaccine* Placebo
(N=18,242) (N=18,379)
n (%) n (%)
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)
Otherc 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.
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 10.
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Table 10: 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
N =18,198
a 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
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
N =19,965
a Na=20,172
Cases Cases
n1 b n1b Vaccine Efficacy %
Subgroup Surveillance Time (n2 ) Surveillance Timec (n2d)
c d (95% CI)
9 169 94.6
All subjectse 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.
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18.2 Efficacy of Primary Series in Adolescents 12 Through 15 Years of Age
A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through
15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.
The efficacy information in adolescents 12 through 15 years of age is presented in Table 11.
Table 11: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence
of 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
n1 b n1b Vaccine Efficacy %
Surveillance Time (n2 ) Surveillance Timec (n2d)
c d (95% CIe)
Adolescents 0 16 100.0
12 through 15 years of age 0.154 (1001) 0.147 (972) (75.3, 100.0)
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or
without evidence of prior SARS-CoV-2 infection
Pfizer-BioNTech Placebo
COVID-19 Vaccine±
Na=1119 Na=1110
Cases Cases
n1 b n1b Vaccine Efficacy %
Surveillance Time (n2 ) Surveillance Timec (n2d)
c d (95% CIe)
Adolescents 0 18 100.0
12 through 15 years of age 0.170 (1109) 0.163 (1094) (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 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. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for surveillance time.
18.3 Immunogenicity of Primary Series in Adolescents 12 Through 15 Years of Age
In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly
selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing
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adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or
virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 12).
Table 12: 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=190 na=170 16 Through 25 Years
Met
Noninferiority
Time GMTc GMTc GMRd Objectivee
Assay Point b (95% CI )c (95% CI )c (95% CI )d (Y/N)
SARS-CoV-2
neutralization 1 month
assay - NT50 after 1239.5 705.1 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 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 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 and
2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis.
* 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. GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1
[12 through 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 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.
18.4 Immunogenicity of a Booster Dose Following a Pfizer-BioNTech COVID-19 Vaccine Primary
Series in Participants 18 Through 55 Years of Age
Effectiveness of a booster dose of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) was based on an
assessment of 50% neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). In Study 2,
analyses of NT50 1 month after the booster dose compared to 1 month after the primary series in individuals
18 through 55 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to
1 month after the booster vaccination demonstrated noninferiority for both geometric mean ratio (GMR) and
difference in seroresponse rates. Seroresponse for a participant was defined as achieving a ≥4-fold rise in NT50
from baseline (before primary series). These analyses are summarized in Table 13 and Table 14.
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Table 13: Geometric Mean 50% Neutralizing Titer (SARS-CoV-2 USA_WA1/2020) – Comparison of
1 Month After Booster Dose to 1 Month After Primary Series – Participants 18 Through
55 Years of Age Without Evidence of Infection up to 1 Month After Booster Dose* – Booster
Dose Evaluable Immunogenicity Population±
1 Month After
1 Month After Booster Dose/
1 Month After Primary 1 Month After Met
Booster Dose Series Primary Series Noninferiority
GMTb GMTb GMRc Objectived
Assay n a (95% CI )b (95% CI )b (97.5% CI ) c (Y/N)
SARS-CoV-2
neutralization assay - 2466.0 750.6 3.29
e
NT50 (titer) 212 (2202.6, 2760.8) (656.2, 858.6) (2.77, 3.90) Y
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of
quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing
titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no.
Note: Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
* Participants who had no serological or virological evidence (up to 1 month after receipt of a booster dose of Pfizer-BioNTech
COVID-19 Vaccine) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative and SARS-CoV-2 not detected
by NAAT [nasal swab]) and had a negative NAAT (nasal swab) at any unscheduled visit up to 1 month after the booster dose
were included in the analysis.
± All eligible participants who had received 2 doses of Pfizer-BioNTech COVID-19 Vaccine as initially randomized, with Dose 2
received within the predefined window (within 19 to 42 days after Dose 1), received a booster dose of Pfizer-BioNTech
COVID-19 Vaccine, had at least 1 valid and determinate immunogenicity result after booster dose from a blood collection within
an appropriate window (within 28 to 42 days after the booster dose), and had no other important protocol deviations as
determined by the clinician.
a. n = Number of participants with valid and determinate assay results at both sampling time points within specified window.
b. 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.
c. GMRs and 2-sided 97.5% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the
corresponding CIs (based on the Student t distribution).
d. Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is >0.67 and the point estimate of the GMR is
≥0.80.
e. 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.
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Table 14: Seroresponse Rate for 50% Neutralizing Titer (SARS-CoV-2 USA_WA1/2020) – Comparison
of 1 Month After Booster Dose to 1 Month After Primary Series – Participants 18 Through
55 Years of Age Without Evidence of Infection up to 1 Month After Booster Dose* – Booster
Dose Evaluable Immunogenicity Population±
Difference
(1 Month After
1 Month After 1 Month After Booster Dose - Met
Booster Dose Primary Series 1 Month After Noninferiority
nb nb Primary Series) Objectivef
Assay N a % (95% CI ) c % (95% CI ) c % (97.5% CI )
d e (Y/N)
SARS-CoV-2
neutralization assay - 199 196
g
NT50 (titer) 200 99.5 (97.2, 100.0) 98.0 (95.0, 99.5) 1.5 (-0.7, 3.7) Y
Abbreviations: CI = confidence interval; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding;
NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome
coronavirus 2; Y/N = yes/no.
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: Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
* Participants who had no serological or virological evidence (up to 1 month after receipt of booster vaccination) of past
SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative and SARS-CoV-2 not detected by NAAT [nasal swab]) and
had a negative NAAT (nasal swab) at any unscheduled visit up to 1 month after booster vaccination were included in the
analysis.
± All eligible participants who had received 2 doses of Pfizer-BioNTech COVID-19 Vaccine as initially randomized, with Dose 2
received within the predefined window (within 19 to 42 days after Dose 1), received a booster dose of Pfizer-BioNTech
COVID-19 Vaccine, had at least 1 valid and determinate immunogenicity result after booster dose from a blood collection
within an appropriate window (within 28 to 42 days after the booster dose), and had no other important protocol deviations as
determined by the clinician.
a. N = number of participants with valid and determinate assay results for the specified assay at baseline, 1 month after Dose 2 and
1 month after the booster dose within specified window. These values are the denominators for the percentage calculations.
b. n = Number of participants with seroresponse for the given assay at the given dose/sampling time point.
c. Exact 2-sided CI based on the Clopper and Pearson method.
d. Difference in proportions, expressed as a percentage (1 month after booster dose – 1 month after Dose 2).
e. Adjusted Wald 2-sided CI for the difference in proportions, expressed as a percentage.
f. Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is > -10%.
g. 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.
18.5 Immunogenicity in Solid Organ Transplant Recipients
From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19
vaccine in solid-organ transplant recipients. N Engl J Med), a single arm study has been conducted in
101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung,
pancreas) 97±8 months previously. A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered
to 99 of these individuals approximately 2 months after they had received a second dose. Among the 59 patients
who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. All
40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. The prevalence
of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose.
Revised: 29 October 2021 48
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 50 of 52
18.6 Immunogenicity of a Booster Dose Following Primary Vaccination with Another Authorized
COVID-19 Vaccine
Effectiveness of a Pfizer-BioNTech COVID-19 Vaccine booster dose (30 mcg modRNA) in individuals who
completed primary vaccination with another authorized COVID-19 Vaccine (heterologous booster dose) is
inferred from immunogenicity data supporting effectiveness of a Pfizer-BioNTech COVID-19 Vaccine booster
dose administered following completion of Pfizer-BioNTech COVID-19 Vaccine primary series and from
immunogenicity data from an independent NIH study Phase 1/2 open-label clinical trial (NCT04889209)
conducted in the United States that evaluated a heterologous booster dose of the Pfizer-BioNTech COVID-19
Vaccine. In this study, adults who had completed primary vaccination with a Moderna COVID-19 Vaccine
2-dose series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech COVID-19
Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who reported no history of
SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of three vaccines: Moderna
COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
Neutralizing antibody titers, as measured by a pseudovirus neutralization assay using a lentivirus expressing the
SARS-CoV-2 Spike protein with D614G mutation, were assessed on Day 1 prior to administration of the
booster dose and on Day 15 after the booster dose. A booster response to the Pfizer-BioNTech COVID-19
Vaccine was demonstrated regardless of primary vaccination.
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 gray caps and labels with gray borders. These multiple dose vials are supplied in a carton
containing 10 multiple dose vials (NDC 59267-1025-4) or 25 multiple dose vials (NDC 59267-1025-3).
One vial contains 6 doses of 0.3 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 gray caps and labels with gray
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 6 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 gray caps and labels with gray
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, vaccine should not be used after 6 months from the date of manufacture printed
on the vial and cartons.
Revised: 29 October 2021 49
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 51 of 52
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 gray caps and labels with gray borders may be
stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After
first puncture, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours
after first puncture.
DO NOT DILUTE PRIOR TO USE.
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, vials may be transported at -90°C to -60°C (-130°F to -76°F) or 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.
Revised: 29 October 2021 50
Case 2:21-cv-00702-CLM Document 40-4 Filed 12/17/21 Page 52 of 52
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1485-0.3
Revised: 29 October 2021
Revised: 29 October 2021 51
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