![]() The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.įor vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.Įmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 ( COVID-19) in individuals 6 months of age and older. *When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.īecause of the potential for vaccine administration errors, including dosing errors, COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons or the respective age-based Fact Sheet. 2 Please refer to Emergency Use Authorization Fact Sheets for Authorized Uses. 1 COMIRNATY® ( COVID-19 Vaccine, mRNA) is also known as the Pfizer-BioNTech COVID-19 Vaccine. In individuals 16 years of age and older, COMIRNATY® ( COVID-19 Vaccine, mRNA) *has been approved as a two-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2. (6 Months Through 4 Years) - DILUTE BEFORE USE, Maroon Cap EUA Fact Sheet for Recipients and Caregivers (12 Years & Up) EUA Fact Sheet for Recipients and Caregivers (5 Through 11 Years) EUA Fact Sheet for Recipients and Caregivers (6 Months Through 4 Years)įDA APPROVED FOR 16 YEARS OF AGE AND OLDER 1 (5 Through 11 Years) – DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers ![]() (12 Years & Up) – DILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers Hoja informativa de la EUA para proveedores de vacunación (12 años de edad y más), DILUIR ANTES DE USAR, tapa morada Hoja informativa de la EUA para proveedores de vacunación (12 años de edad y más), NO DILUIR, tapa gris Hoja informativa de la EUA para proveedores de vacunación (de 5 a 11 años de edad), DILUIR ANTES DE USAR, tapa anaranjada Hoja informativa de la EUA para receptores y cuidadores (12 años de edad y más) Hoja informativa de la EUA para receptores y cuidadores (de 5 a 11 años de edad)Įnglish EUA Fact Sheet for Vaccination Providers Updates to non-English Fact Sheets may be delayed. Years) EUA Fact Sheet for Recipients and Caregivers (6 Months Through 4 Up) EUA Fact Sheet for Recipients and Caregivers (5 Through 11 English EUA Fact Sheet for Vaccination Providers (12 Years & Up) –ĭILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 Years & Up) –ĭO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (5 Through 11 Years) –ĭILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Vaccination Providers (6 Months Through 4 Years) –ĭILUTE BEFORE USE, Maroon Cap EUA Fact Sheet for Recipients and Caregivers (12 Years &
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