Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

January 3, 2022: FDA expands eligibility for the Pfizer-BioNTech COVID-19 Vaccine to include the use of a single booster dose in individuals 12 and older at least 5 months after primary vaccination with Pfizer-BioNTech COVID-19 Vaccine. Read the press release or view booster eligibility.

Comirnaty Information Pfizer-BioNTech Fact Sheets Pfizer-BioNTech Fact Sheet Translations Información sobre las vacunas para el COVID-19

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 and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least five months after completing a primary series of the vaccine.

The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Moderna and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions to provide information about the use of the vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines.

Comirnaty Information

Information	Last Updated
Package Insert	August 23, 2021
Summary Basis for Regulatory Action	November 8, 2021
Approval Letter	August 23, 2021
Supplement Approval Letter	December 16, 2021
FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español)	October 20, 2021
CDC-issued Emergency Use Instructions	November 17, 2021

Pfizer-BioNTech Fact Sheets (English) and FAQs

Fact Sheet / FAQs	Vaccine Recipient Group	Last Updated
For Healthcare Providers	12 years of age and older, purple cap (must dilute)	January 31, 2022
For Healthcare Providers	12 years of age and older, gray cap (no dilution) This formulation is not yet available in the United States.	January 31, 2022
For Healthcare Providers	5 - 11 years of age, orange cap (must dilute)	January 3, 2022
For Recipients and Caregivers	12 years of age and older	January 31, 2022
For Recipients and Caregivers	5 - 11 years of age	January 3, 2022
Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine	All	November 4, 2021

Pfizer-BioNTech Regulatory Information

Information	Date
Letter Granting EUA Amendment	January 31, 2022
Decision Memorandum Addendum	January 6, 2021
Decision Memorandum	December 30, 2021
Letter of Authorization (Reissued)	January 3, 2022
Decision Memorandum	December 8, 2021
Decision Memorandum Addendum	November 19, 2021
Decision Memorandum	November 19, 2021
Decision Memorandum	October 29, 2021
Advisory Committee Meeting Information	October 26, 2021
Decision Memorandum	October 20, 2021
Decision Memorandum	September 24, 2021
Advisory Committee Meeting Information	September 17, 2021
Letter Granting EUA Amendment	September 1, 2021
Concurrence Letter	August 22, 2021
Decision Memorandum	August 12, 2021
Letter Granting EUA Amendment	May 19, 2021
FDA Decision Memorandum	May 10, 2021
Letter Granting EUA Amendment	April 6, 2021
Letter Granting EUA Amendment	January 22, 2021
Letter Granting EUA Amendment	January 6, 2021
FDA Decision Memorandum	December 11, 2020
Advisory Committee Meeting Information	December 10, 2020

Media Materials and Webcasts

Information	Date
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 (January 3, 2022)	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 (January 3, 2022)	5 - 11 years of age	中文 (Chinese, Simplified)
برگه حاوی اطلاعات ومعلومات برای متقاضیان و مسؤلین بهداشتی در مورد تطبیق واکسین PFIZER-BIONTECH کووید 19 مرض شیوع یافتهء سال 2019 در میان افرادیکه در سنین 5 الی 11 سال قرار دارند. (January 3, 2022)	5 - 11 years of age	دری, (Dari)
FYÈ ENFÒMASYON SOU VAKSEN POU RECIPÈ AK MOUN K’AP PRAN SWEN SANTE SOU VAKSEN PFIZER-BIONTECH COVID-19 POU ANPECHE MALADI CORONAVIRUS 2019 (COVID-19) POU ITILIZE NAN MOUN KI GEN 5 AN RIVE 11 AN DE LAJ (January 3, 2022)	5 - 11 years of age	Kreyòl Ayisyen (Haitian Creole)
DAIM NTAWV QHIA TSEEB TXOG TSHUAJ TIV THAIV KAB MOB RAU COV NEEG TAU TXAIS KEV PAB THIAB COV NEEG ZOV TU TXOG QHOV TSHUAJ TIV THAIV KAB MOB COVID-19 PFIZER-BIONTECH LOS TIV THAIV TUS KAB MOB CORONAVIRUS 2019 (COVID-19) NTAWM COV TIB NEEGHNUB NYOOG 5 TXOG 11 XYOOS (January 3, 2022)	5 - 11 years of age	Hmoob (Hmong)
បញ្ជីហេតុការណ៍ព័ត៌មានវ៉ាក់សាំងសម្រមាប់អ្នកទទួល និងអ្នកថែរទាំអ្ាំពីវ៉ាក់សាំងេវឺេសឺ បយូទិចកូវីដ19 (PFIZER-BIONTECH COVID-19)ហដើម្បីបង្ការជម្ងឺកូវីដ-19(COVID-19) សម្រមាប់ហម្របើម្រាស់ជាម្ួយបុគ្គលថដលមានអាយុចាប់ពី 5 ដល់11 ឆ្នាំ (January 3, 2022)	5 - 11 years of age	ភាសាអង់គ្លេស (Khmer)
5 세에서 11 세에 해당하는사람들에게 코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한화이저 (PFIZER)-바이오엔텍 (BIONTECH) 코비드-19 백신에 대한 환자와 의료진을 위한 백신 정보지 (January 3, 2022)	5 - 11 years of age	한국어 (Korean)
او تروکلن ۵ه ل ي اوکنووک هنملراي او پکنووتن اخیسی سکد وا هن په اړی سکوا (PFIZER-BIONTECH COVID-19) د PFIZER- د هراپل يوینخ) م۱۹ډ-ېووک( وغۍران سروی و۱۹وېډ-وک کال د۲۰۱۹ې د ک وناسک ېروپ ونکل ۱۱ ڼهاپ تقیي حقن اموې معلنو نران د کی سک وا۱۹وېډ-وکBI (January 3, 2022)	5 - 11 years of age	Pashto
FICHA INFORMATIVA PARA DESTINATÁRIOS CUIDADORES SOBRE A VACINA PFIZER-BIONTECH COVID-19 PARA PREVENIR A DOENÇA DO CORONAVÍRUS 2019 (COVID-19) PARA USO EM INDIVÍDUOS DE 5 A 11 ANOS DE IDADE (January 3, 2022)	5 - 11 years of age	Português (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУ О ВАКЦИНЕ PFIZER-BIONTECH COVID-19 ДЛЯ ПРЕДОТВРАЩЕНИЯ ЗАБОЛЕВАНИЯ КОРОНАВИРУСНОЙ ИНФЕКЦИЕЙ 2019 (COVID-19) У ЛИЦ В ВОЗРАСТЕ ОТ 5 ДО 11 ЛЕТ (January 3, 2022)	5 - 11 years of age	Русский (Russian)
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 (January 3, 2022)	5 - 11 years of age	Tagalog (Tagalog)
2019-YIL KORONAVIRUS KASALLIGINING (COVID-19) OLDINI OLINISH UCHUN PFIZER-BIONTECH COVID-19 VAKSINA HAQIDA UNI OLUVCHILAR VA ULARNI PARVARISHLAYDIGAN SHAXSLAR UCHUN VAKSINA HAQIDA MA’LUMOTLAR VARAKASI 5 DAN 11 YOSHGACHA (January 3, 2022)	5 -11 years of age	O'zbek (Uzbek)
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 (January 3, 2022)	5 -11 years of age	Tiếng Việt (Vietnamese)