Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
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 the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 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.
Comirnaty Information
| Information | Last Updated |
|---|---|
| Approval Letter | July 8, 2022 |
| Package Insert (purple cap) | July 8, 2022 |
| Package Insert (gray cap) | July 8, 2022 |
| 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) | July 8, 2022 |
| Fact Sheet | Healthcare Providers | 12 years of age and older, gray cap (no dilution) | July 8, 2022 |
| Fact Sheet | Recipients and Caregivers | 12 years of age and older | July 8, 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
| Information | Date |
|---|---|
| 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 6 months through 4 years of age
| Fact Sheet | Vaccine Recipient Group | Language |
|---|---|---|
| 6 months - 4 years of age | Español (Spanish) | |
|
面向 6 个月至 4 岁的个体使用的用于预防 2019 年冠状病毒病 (COVID-19) 的辉瑞生物技术 COVID-19 疫苗的受种者和监护人员情况说明书 |
6 months - 4 years | 中文 (Chinese, Simplified) |
|
6개월에서 4세 사이의 개인에 사용하기 위한 2019 코로나 바이러스 질병(COVID-19) 예방을 위한 화이자-바이오엔텍 COVID-19 백신에 대한 수혜자 및 간병인을 위한 팩트 시트 |
6 months - 4 years | 한국어 (Korean) |
| 6 months - 4 years | Tagalog (Tagalog) | |
|
PHIẾU THỰC TẾ DÀNH CHO NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ THUỐC CHỮA BỆNH PFIZER-BIONTECH COVID-19 ĐỂ PHÒNG NGỪA BỆNH HẠI LÃO HÓA 2019 (COVID-19) ĐỂ SỬ DỤNG CHO CÁ NHÂN 6 THÁNG QUA 4 TUỔI |
6 months - 4 years | Tiếng Việt (Vietnamese) |
Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers for 5 through 11 years of age
| Fact Sheet | Vaccine Recipient Group | Language |
|---|---|---|
| 5 - 11 years of age | Español (Spanish) | |
|
为接种者和护理者提供的关于用于预防2019新冠肺炎（COVID-19）的辉瑞生物技术公司2019新冠肺炎疫苗以个人使用的信息概况说明书 5岁至11岁 |
5 - 11 years of age | 中文 (Chinese, Simplified) |
|
5 세에서 11 세에 해당하는사람들에게 코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한화이저 (PFIZER)-바이오엔텍 (BIONTECH) 코비드-19 백신에 대한 환자와 의료진을 위한 백신 정보지 |
5 - 11 years of age | 한국어 (Korean) |
| 5 - 11 years of age | Tagalog (Tagalog) | |
| 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