Pfizer-BioNTech COVID-19 Vaccines
Comirnaty, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent
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.
Comirnaty is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.
Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as:
- The first two doses of the three-dose primary series for children 6 months through 4 years of age.
- A two-dose primary series for individuals 5 years of age and older.
- A third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for emergency use to prevent COVID-19 as:
- The third dose of the three-dose primary series following two doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age.
- A single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine.
- A single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine in individuals 5 years of age and older.
Comirnaty Information (FDA Approved)
| Information | Last Updated |
|---|---|
| Package Insert (purple cap) | July 8, 2022 |
| Package Insert (gray cap) | July 8, 2022 |
| Regulatory Information | August 25, 2022 |
| FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español) | February 8, 2022 |
| CDC-issued Emergency Use Instructions (updated) | February 11, 2022 |
Pfizer-BioNTech Fact Sheets (English)
Health Care Provider Materials
| Material | Vaccine Purpose | Vaccine Recipient Group | Last Updated |
|---|---|---|---|
| Fact Sheet | Primary Series and Bivalent Booster | 6 months through 4 years, maroon cap (must dilute) | March 14, 2023 |
| Fact Sheet | Primary Series | 5 years through 11 years of age, orange cap (must dilute) | December 8, 2022 |
| Fact Sheet | Bivalent Booster | 5 years through 11 years of age, orange cap (must dilute) | December 8, 2022 |
| Fact Sheet | Primary Series | 12 years of age and older, purple cap (must dilute) | December 22, 2022 |
| Fact Sheet | Primary Series | 12 years of age and older, gray cap (no dilution) | December 8, 2022 |
| Fact Sheet | Bivalent Booster | 12 years of age and older, gray cap (no dilution) | December 8, 2022 |
| Dear Healthcare Provider Letter | Change in Third Dose of 3-Dose Primary Series | 6 months through 4 years of age | December 8, 2022 |
| Dear Healthcare Provider Letter | Primary Series and Bivalent Booster | 5 years through 11 years of age, orange cap (must dilute) | October 12, 2022 |
| Dear Healthcare Provider Letter | Bivalent Booster | 12 years of age and older | August 31, 2022 |
| Dear Healthcare Provider Letter | Primary Series | 6 months through 4 years, maroon cap (must dilute) | June 17, 2022 |
Recipient and Caregiver Materials
| Material | Vaccine Purpose | Vaccine Recipient Group | Last Updated |
|---|---|---|---|
| Fact Sheet | Primary Series and Bivalent Booster | 6 months through 4 years of age | March 14, 2023 |
| Fact Sheet | Primary Series and Bivalent Booster | 5 years through 11 years of age | December 8, 2022 |
| Fact Sheet | Primary Series and Bivalent Booster | 12 years of age and older | December 8, 2022 |
Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)
Federal Register Notices
| Title | Date |
| Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability | January 19, 2021 |
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