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.