COVID-19 vaccines by
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Important Safety Information
Do not administer
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
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
Postmarketing data with authorized or approved monovalent mRNA
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 (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to
Limitation of Vaccine Effectiveness
The safety of
safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech
COVID-19Vaccine (monovalent formulation is no longer authorized for use in the United States),
safety data from clinical trials which evaluated booster vaccination with Pfizer-BioNTech
- 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-19Vaccine (monovalent formulation is no longer authorized for use in the United States) and Pfizer-BioNTech COVID-19Vaccine, 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
Vaccination providers enrolled in the federal
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.
Indication & Authorized Use
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the
IndicationCOMIRNATY® 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.
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.