Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- tozinameran and famtozinameran injection, suspension
Pfizer Manufacturing Belgium NV
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE: EMERGENCY USE AUTHORIZATION OF PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)
| 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, Bivalent (Original and Omicron BA.4/BA.5) under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) suspension for injection, for intramuscular use.Original EUA Authorized Date: 12/2020 Most Recent EUA Authorized Date: 4/2023 ——–RECENT MAJOR CHANGES ——–Dosage and Administration, Dose and Schedule (2.3) 4/2023 | Individuals 6 months through 4 years of age previously vaccinated with the monovalent Pfizer-BioNTech COVID-19 Vaccine2 (2.3) | ||||||
| Age | Number of Previous Doses of Pfizer-BioNTech COVID-19 Vaccine | Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color | Dosing Regimen, Dose and Schedule | ||||
| 6m-4y | 1 previous dose | Maroon | 2 doses3 , 0.2 mL each Dose 1: 3 weeks after receipt of Pfizer-BioNTech COVID-19 Vaccine Dose 2: ≥8 weeks after Dose 1 | ||||
| ——–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, Bivalent (Original and Omicron BA.4/BA.5) 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. (1)The Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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, Bivalent (Original and Omicron BA.4/BA.5), information on available alternatives, and additional information on COVID-19. | 6m-4y | 2 previous doses | Maroon | Single dose, 0.2 mL ≥8 weeks after receipt of second dose of Pfizer-BioNTech COVID-19 Vaccine | |||
| 6m-4y | 3 previous doses | Maroon | Single dose, 0.2 mL ≥2 months4 after receipt of third dose of Pfizer-BioNTech COVID-19 Vaccine | ||||
| ——–DOSAGE AND ADMINISTRATION ——–For intramuscular injection only. (2) | 2 The monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use in the United States. 3 Notwithstanding the age limitations for use of the vaccine, individuals turning from 4 to 5 years of age during the vaccination series should receive 2 doses with Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in vials with maroon caps and labels with maroon borders. 4 For individuals with certain kinds of immunocompromise (as defined in footnote 6) previously vaccinated with three doses of the monovalent Pfizer BioNTech COVID-19 Vaccine, see text below tables for dosing interval. | ||||||
| Individuals 6 months of age and older not previously vaccinated with a COVID-19 vaccine (2.3) | |||||||
| Age | Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color | Dosing Regimen, Dose and Schedule | Individuals 5 years of age and older previously vaccinated with 1 or more doses of a monovalent COVID-19 vaccine5 (2.3) | ||||
| 6m-4y1 | Maroon | 3 doses, 0.2 mL each Dose 1: Week 0 Dose 2: Week 3 Dose 3: ≥ 8 weeks after Dose 2 | Age | Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color | Dosing Regimen, Dose and Schedule | ||
| 5-11y | Orange | Single dose, 0.2 mL | 5-11y | Orange | Single dose, 0.2 mL ≥2 months after monovalent COVID-19 vaccine | ||
| 12-64y | Gray | Single dose, 0.3 mL | 12-64y | Gray | Single dose, 0.3 mL ≥2 months after monovalent COVID-19 vaccine | ||
| ≥65y | Gray | Single dose, 0.3 mLOne additional dose, 0.3 mL, may be administered ≥ 4 months after first dose of an authorized bivalent COVID- 19 vaccine | ≥65y | Gray | Single dose, 0.3 mL ≥2 months after monovalent COVID-19 vaccine One additional dose, 0.3 mL, may be administered ≥4 months after first dose of an authorized bivalent COVID-19 vaccine | ||
| 1 Notwithstanding the age limitations for use of the vaccine, individuals turning from 4 to 5 years of age during the vaccination series should receive all doses with Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in vials with maroon caps and labels with maroon borders. | 5 Monovalent refers to a COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2. | ||||||
| Individuals with Certain Kinds of Immunocompromise6 For individuals with certain kinds of immunocompromise 6 months through 4 years of age who have received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent), a fourth dose (0.2 mL) with Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 1 month following the most recent dose; additional doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. (2.3) For individuals with certain kinds of immunocompromise 5 years of age and older, a single additional age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. (2.3) | |||||||
| ——–DOSAGE FORMS AND STRENGTHS ——–Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for injection.
——–CONTRAINDICATIONS ——–Known history of a severe allergic reaction (e.g., anaphylaxis) to any component of Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. (4)— —–WARNINGS AND PRECAUTIONS —–— 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. (5.2) | 6 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.——–ADVERSE REACTIONS ——–Solicited adverse reactions included:
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 COVID19 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 (6.3)See FACT SHEET FOR RECIPIENTS AND CAREGIVERS. | ||||||
FULL FACT SHEET FOR HEALTHCARE PROVIDERS
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