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COVID-19 vaccines by
BioNTech and Pfizer


AUTHORIZED VACCINE OPTION FOR INDIVIDUALS 6 MONTHS THROUGH 11 YEARS OF AGE

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APPROVED VACCINE OPTION FOR INDIVIDUALS 12+ YEARS OF AGE

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ORDERING AVAILABLE THROUGH PFIZER PRIME*

Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be
placed by eligible
healthcare professionals directly with Pfizer through Pfizer Prime online or by
calling 1-800-533-4535.

Visit Pfizer Prime

*Eligible healthcare providers can order COVID-19 vaccines directly from
Pfizer. If preferred, orders may be placed with your facility’s wholesaler.


FOR MORE INFORMATION

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Service

Including General Product Questions

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Information
Visit PfizerMedicalInformation.com

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Call 1-800-666-7248

Pfizer Customer Service

Including General
Product Questions

Call 1-800-879-3477

Medical Information

Visit
PfizerMedicalInformation.com

Shipment Support US Trade Customer Service

Call 1-800-666-7248

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New York, NY 10001

Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
Marketing Authorization Holder

Manufactured by
Pfizer Inc.
New York, NY 10001

COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech
proprietary mRNA technology, were developed by both BioNTech and Pfizer.

COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech
proprietary mRNA technology, were developed by both BioNTech and Pfizer.

Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
Marketing Authorization Holder

Manufactured by
Pfizer Inc.
New York, NY 10001

COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech
proprietary mRNA technology, were developed by both BioNTech and Pfizer.

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IMPORTANT SAFETY INFORMATION

Do not administer Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with
a known history of a severe allergic reaction (e.g., anaphylaxis) to any
component of Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine,
Bivalent, or COMIRNATY® (COVID-19 Vaccine, mRNA).

MANAGEMENT OF ACUTE ALLERGIC REACTIONS

Appropriate medical treatment 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, Bivalent.

Monitor Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to
Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are
manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines
demonstrate increased risks of myocarditis and pericarditis, particularly within
the first week following vaccination. For the Pfizer-BioNTech COVID-19 Vaccine,
the observed risk is highest in males 12 through 17 years of age. Although some
cases required intensive care support, available data from short-term follow-up
suggest that most individuals have had resolution of symptoms with conservative
management. Information is not yet available about potential long-term sequelae.

The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of
myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html)

SYNCOPE

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

ALTERED IMMUNOCOMPETENCE

Immunocompromised persons, including individuals receiving immunosuppressive
therapy, may have a diminished response to Pfizer-BioNTech COVID-19 Vaccine,
Bivalent.

LIMITATION OF VACCINE EFFECTIVENESS

Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine
recipients.

ADVERSE REACTIONS

The safety of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months
of age and older is based on the safety data accrued from the formulations
described below because these vaccines are manufactured using the same process:

 * safety data from clinical trials which evaluated primary and booster
   vaccination with Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is
   no longer authorized for use in the United States),
 * safety data from clinical trials which evaluated booster vaccination with
   Pfizer-BioNTech COVID-19 Vaccine, Bivalent,
 * safety data from a clinical study which evaluated a booster dose of bivalent
   vaccine (Original and Omicron BA.1), [not authorized or approved in the U.S.,
   hereafter referred to as bivalent vaccine (Original and Omicron BA.1)] and
 * postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine (monovalent
   formulation is no longer authorized for use in the United States) and
   Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Solicited adverse reactions include:

 * 6 months through 23 months of age:
   Injection site redness, swelling, and tenderness; decreased appetite,
   drowsiness, fever, irritability.
 * 2 years of age and older:
   Injection site pain, redness, and swelling; chills, diarrhea, fatigue, fever,
   headache, new or worsened joint pain, new or worsened muscle pain, vomiting.

Additional adverse reactions, some of which may be serious, may become apparent
with more widespread use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must
report all vaccine administration errors and all serious adverse events to the
Vaccine Adverse Event Reporting System (VAERS) by submitting 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, Bivalent EUA” in the description section of the report. To the
extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a
copy of the VAERS form to Pfizer www.pfizersafetyreporting.com

Please click for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider
and Recipient and Caregiver EUA Fact Sheets

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5),
hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 6 months of
age and older.

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INDICATION & AUTHORIZED USE

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized
Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used
interchangeably to provide the COVID-19 vaccination series.

INDICATION

COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus
disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) in individuals 16 years of age and older.

AUTHORIZED USE

COMIRNATY® (COVID-19 Vaccine, mRNA) is also authorized for emergency use in
individuals 5 years of age and older and to provide a third dose to individuals
12 years of age and older who have been determined to have certain kinds of
immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization
(EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been
determined to have certain kinds of immunocompromise.

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized
Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used
interchangeably to provide the COVID-19 vaccination series.

COMIRNATY® has the same formulation as the authorized vaccine Pfizer-BioNTech
COVID-19 Vaccine, and they can be used interchangeably without presenting any
safety or effectiveness concerns. Although they may be manufactured in different
facilities, the products offer the same safety and effectiveness.

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