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EUA Fact Sheet Updates
Please be aware that Pfizer-BioNTech COVID-19 Vaccine is now available in four formulations. For additional information on differences across age groups and formulations please see EUA Fact Sheet for Vaccination Providers below.
To Azerbaijan the formulation in a multiple dose vial with a purple cap FOR 12 YEARS OF AGE AND OLDER was supplied.
Label Update: Effective 17 June 2022
Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a maroon cap and a label with a maroon border is authorised for use to provide a 3-dose primary series to individuals 6 months through 4 years of age.
Important Safety Information updated to include new data on primary series adverse events for participants 6 months through 4 years of age in clinical studies and a new section on post authorisation experience.
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 - 12 years of age and older Do Not Dilute, Gray Cap
• EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap
• EUA Fact Sheet for Vaccination Providers - 6 months through 4 years of age Dilute Before Use, Maroon Cap
Label Update: Effective 17 May 2022
Expiry dates extending from 9 months to 12 months for all formulations.
Important Safety Information updated to include new data on myocarditis and pericarditis.
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