On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use as a:
- Three-dose primary series for individuals 6 months through 4 years of age.
- Two-dose primary series for individuals 5 years of age and older.
- Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise.
- Single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.
- First booster dose for individuals 12 years of age and older at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty vaccine.
- First booster dose for individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for this first booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
- Second booster dose for individuals 50 years of age and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
- Second booster dose for individuals 12 years of age and older with certain kinds of immunocompromise at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
On February 11, 2022, in consultation with FDA, CDC updated the emergency use instructions to provide information about the primary, additional, and booster doses of the Pfizer COVID-19 vaccines in certain individuals.
|Package Insert (purple cap)||December 2021|
|Package Insert (gray cap)||December 2021|
|Approval Letter||August 23, 2021|
|Supplement Approval Letter||December 16, 2021|
|Summary Basis for Regulatory Action||November 8, 2021|
|FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español)||February 2, 2022|
|CDC-issued Emergency Use Instructions (updated)||February 11, 2022|
Pfizer-BioNTech Fact Sheets (English) and FAQs
|Material||Audience||Vaccine Recipient Group||Last Updated|
|Fact Sheet||Healthcare Providers||6 months through 4 years, maroon cap (must dilute)||June 17, 2022|
|Dear Healthcare Provider Letter||Healthcare Providers||6 months through 4 years, maroon cap (must dilute)||June 17, 2022|
|Fact Sheet||Recipients and Caregivers||6 months through 4 years of age||June 28, 2022|
|Fact Sheet||Healthcare Providers||5 years through 11 years of age, orange cap (must dilute)||June 17, 2022|
|Fact Sheet||Recipients and Caregivers||5 years through 11 years of age||June 28, 2022|
|Fact Sheet||Healthcare Providers||12 years of age and older, purple cap (must dilute)||June 17, 2022|
|Fact Sheet||Healthcare Providers||12 years of age and older, gray cap (no dilution)||June 17, 2022|
|Fact Sheet||Recipients and Caregivers||12 years of age and older||June 17, 2022|
|Wall Chart||Healthcare Providers||All||June 17, 2022|
|Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine||All||All||February 16, 2022|
Pfizer-BioNTech Regulatory Information
Media Materials and Webcasts
|Press Conference||June 17, 2022|
|Press Release||June 17, 2022|
|Advisory Committee Webcast||June 15, 2022|
|Press Release||May 17, 2022|
|Media Call||March 29, 2022|
|Press Release||March 29, 2022|
|Press Release||January 3, 2022|
|Press Release||November 19, 2021|
|Press Release||October 29, 2021|
|Press Conference||October 29, 2021|
|Advisory Committee Webcast||October 26, 2021|
|Press Release||October 20, 2021|
|Media Call||October 20, 2021|
|Press Release||September 22, 2021|
|Advisory Committee Webcast||September 17, 2021|
|Press Release||August 23, 2021|
|Press Release||August 12, 2021|
|FDA In Brief||May 19, 2021|
|Press Release||May 10, 2021|
|Press Conference||May 10, 2021|
|Press Release||February 25, 2021|
|Press Release||December 11, 2020|
|Press Conference||December 11, 2020|
|Advisory Committee Webcast||December 10, 2020|
Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers for 5 through 11 years of age
|Fact Sheet||Vaccine Recipient Group||Language|
HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 5 A 11 AÑOS
|5 - 11 years of age||Español (Spanish)|
|5 - 11 years of age||中文 (Chinese, Simplified)|
|5 - 11 years of age||한국어 (Korean)|
BAKUNA IMPORMASYON FACT SHEET PARA SA MGA TUMANGGAP AT MGA TAGAPAG-ALAGA TUNGKOL SA PFIZER-BIONTECH COVID-19 BAKUNA UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) PARA SA PAGGAMIT SA MGA INDIBIDWAL 5 HANGGANG 11 TAONG GULANG
|5 - 11 years of age||Tagalog (Tagalog)|
BẢNG THÔNG TIN VỀ VẮC XIN DÀNH CHO NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ VẮC XIN PFIZER-BIONTECH COVID-19 NHẰM PHÒNG NGỪA BỆNH CORONAVIRUS 2019 (COVID-19) ĐỂ SỬ DỤNG CHO CÁ NHÂN TỪ 5 TỚI 11 TUỔI
|5 -11 years of age||Tiếng Việt (Vietnamese)|
Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers for 12 years of age and older