Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent

——–EMERGENCY USE AUTHORIZATION ——–The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age. (1)The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), which is supplied in multiple dose vials with yellow caps and labels with yellow borders and in single dose vials with blue caps and labels with blue borders, is not licensed for any use. (1)See Full Fact Sheet for Healthcare Providers for the justification for emergency use of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), information on available alternatives, and additional information on COVID-19.

a. For individuals with certain kinds of immunocompromise, see text below tables for dosing information.

b. COVID-19 vaccine refers to the monovalent COVID-19 vaccines that encode the spike protein of the original SARS-CoV-2 and the bivalent COVID-19 vaccines encoding the spike protein of original SARS-CoV-2 and of the Omicron variant lineages BA.4 and BA.5 that are no longer authorized for use in the United States.

Individuals with Certain Kinds of Immunocompromise

Individuals 6 months through 11 years of age with certain kinds of immunocompromise should complete at least a 3-dose series with an age-appropriate dose and dosing schedule of a COVID-19 vaccine. At least 1 dose should be with a COVID-19 vaccine (2023-2024 Formula).

Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. (2.3)

——–DOSAGE AND ADMINISTRATION ——–For intramuscular injection only. (2)

——–DOSAGE FORMS AND STRENGTHS——– Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. A single dose is 0.3 mL. (3)

——–CONTRAINDICATIONS——– History of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or following a previous dose of a Pfizer-BioNTech COVID-19 vaccine. (4)

——–WARNINGS AND PRECAUTIONS——-

Postmarketing data with authorized or approved 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. (5.2)

——–ADVERSE REACTIONS——– Solicited adverse reactions included:

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6 months through 23 months of age: Injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; irritability. (6.1)

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2 through 11 years of age: Injection site pain; redness and swelling; chills; diarrhea; fatigue; fever; headache; new or worsened joint pain; new or worsened muscle pain; vomiting. (6.1)

Vaccination providers must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 (2023-2024 Formula) 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 https://www.pfizersafetyreporting.com/(6.3)See FACT SHEET FOR RECIPIENTS AND CAREGIVERS.