Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- tozinameran and famtozinameran injection, suspension
PFIZER-BIONTECH COVID-19 VACCINE- raxtozinameran injection, suspension
Pfizer Manufacturing Belgium NV
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE: EMERGENCY USE AUTHORIZATION OF PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA), FOR 6 MONTHS THROUGH 11 YEARS OF AGE
HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use Pfizer-BioNTech COVID-19 Vaccine under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for Pfizer-BioNTech COVID-19 Vaccine.Pfizer-BioNTech COVID-19 Vaccine suspension for injection, for intramuscular use.2023-2024 FormulaOriginal EUA Authorized Date: 12/2020 Most Recent EUA Authorized Date: 9/2023 ——–RECENT MAJOR CHANGES ——–Dosage and Administration, Preparation for Administration (2.1) 9/2023Dosage and Administration, Administration (2.2) 9/2023Dosage and Administration, Dose and Schedule (2.3) 9/2023 Dosage Forms and Strengths (3) 9/2023 | Individuals 5 Years Through 11 years of Age Irrespective of COVID-19 Vaccination Status | ||||
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Vial Cap and Label Border Color | Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Dosing Regimen, Dose and Schedulea | ||||
Blue | Single dose, 0.3 mLIf previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccineb | ||||
——–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) | ||||
Individuals 6 Months Through 4 Years of Age by Pfizer-BioNTech COVID-19 Vaccination Status | ——–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) | ||||
Number of Previous Doses of Pfizer-BioNTech COVID-19 vaccine(s)a | Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Vial Cap and Label Border Color | Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Dosing Regimen, Dose and Scheduleb | ——–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) | ||
0c | Yellow | 3 dosesd , 0.3 mL each Dose 1: Week 0 Dose 2: Week 3 Dose 3: ≥8 weeks after Dose 2 | ——–ADVERSE REACTIONS——– Solicited adverse reactions included:
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1 | Yellow | 2 dosesd , 0.3 mL each Dose 1: 3 weeks after receipt of the previous dose of Pfizer-BioNTech COVID-19 vaccinea Dose 2: ≥8 weeks after Dose 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. | ||
2 to 4 | Yellow | Single dose, 0.3 mL ≥8 weeks after receipt of the last previous dose of Pfizer-BioNTech COVID-19 vaccinea | |||
a. Previous doses of Pfizer-BioNTech COVID-19 vaccine(s) refers to doses with Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). These vaccines are no longer authorized for use in the United States. b. For individuals with certain kinds of immunocompromise previously vaccinated with Pfizer-BioNTech COVID-19 vaccines, see text below tables for dosing information. c. Not previously vaccinated with any COVID-19 vaccine. d. For individuals turning from 4 to 5 years of age during the vaccination series, administer all doses with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders. | |||||
FULL FACT SHEET FOR HEALTHCARE PROVIDERS
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