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EUA Fact Sheet Updates
Please be aware that Pfizer-BioNTech COVID-19 Vaccine is now available in three formulations. For additional information on differences across age groups and formulations please see Vaccine Formulations Guide on the home page of this website.
Label Update: Effective 17 May 2022
Second Booster Dose: 12 years of age and older
• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorised or approved COVID-19 vaccine.
• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) may be administered at least 4 months after receipt of a first booster dose of any authorised or approved COVID-19 vaccine to individuals 12 years of age and older with certain kinds of immunocompromise
Booster Dose: 5 through 11 years of age
• A single Pfizer‑BioNTech COVID-19 Vaccine booster dose supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) may be administered, after dilution, at least 5 months after completing a primary series of the Pfizer‑BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.
Expiry dates extending from 9 months to 12 months for all formulations.
Important Safety Information updated to include new data on myocarditis and pericarditis.
Click below to view:
• EUA Fact Sheet for Vaccination Providers - 12 year of age and older Dilute Before Use, Purple Cap
• EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap