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 .
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.
Pfizer-BioNTech Fact Sheets (English) and FAQs
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)
Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers for 12 years of age and older
Fact Sheet
Vaccine Recipient Group
Language
HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE COMIRNATY (VACUNA DE ARNm CONTRA EL COVID-19) Y LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 12 AÑOS O MÁS
(January 31, 2022)
12 years of age and older
Español (Spanish)
关于复必泰 (2019核糖核酸新冠肺炎疫苗)以及辉瑞-BioNTech2019新冠肺炎疫苗预防2019新冠肺炎的接受者和护理者须知
(January 31, 2022)
12 years of age and older
中文 (Chinese, Simplified)
صفحه معلومات واکسین برای دریافت کننده گان و مراقبت کننده گان
در مورد کومیرنتی (واکسین کووید -۱۹، ام ار ان ای)
و واکسین کووید-۱۹فایزر-بیو ان تک برای جلوگیری از مرض ویروس کرونا ۲۰۱۹(کووید-۱۹)
(January 3, 2022)
12 years of age and older
دری, (Dari)
FYÈ ENFÒMASYON SOU VAKSEN POU RECIPÈ AK MOUN K’AP PRAN SWEN SANTE SOU COMIRNATY (VAKSEN POU COVID-19, mRNA) AK VAKSEN PFIZER-BIONTECH COVID-19 POU ANPECHE MALADI CORONAVIRUS 2019 (COVID-19)
(January 3, 2022)
12 years of age and older
Kreyòl Ayisyen (Haitian Creole)
DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU TXAIS KEV PAB THIAB COV NEEG ZOV TU TXOG COMIRNATY (TSHUAJ TIV THAIV KAB MOB COVID-19, mRNA) THIAB QHOV TSHUAJ TIV THAIV KAB MOB COVID-19 PFIZER-BIONTECH LOS TIV THAIV TUS KAB MOB CORONAVIRUS 2019 (COVID-19)
(January 3, 2022)
12 years of age and older
Hmoob (Hmong)
បីេហតុរណ៍ព័ត៌នក់ំងស្រប់អកទទួលនិងអកែថរំ អំពីក់ំង COMIRNATY (COVID-19 VACCINE, mRNA) និងហឺហ្សឺ ប្យទិចកូវដ19 (THE PFIZER-BIONTECH COVID-19) ស្រប់បុគលក់ៗ ែដលនយុប់ពី 12 ំ េឡើងទ
(January 3, 2022)
12 years of age and older
ភាសាអង់គ្លេស (Khmer)
코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한 코멀나티 (코비드-19 백신, 메신저 RNA)와 화이저 (PFIZER)-바이오엔텍 (BIONTECH) 코비드-19 백신에 대한 환자와 의료진을 위한 백신 정보지
(January 31, 2022)
12 years of age and older
한국어 (Korean)
په اړه واکس ن ی اخیستوون ي ک او پاملرنه کوون ي ک او په ۱۲ (COMIRNATY (COVID-19 Vaccine, mRNA) د
کلنو او له دې لوړ عمر لرونکو کسانو ې ک د ۲۰۱۹ د کووېډ- ۱۹ ۍ )کووې ډ ن
ویروس ناروغ - ۱۹ ( مخنیوي لپاره د کووېډ - ۱۹ ي حقیقت پاڼه PFIZER-BIONTECH
(January 3, 2022)
12 years of age and older
Pashto
FICHA INFORMATIVA PARA DESTINATÁRIOS E CUIDADORES SOBRE COMIRNATY (COVID-19 VACINA, mRNA) E VACINA PFIZER-BIONTECH COVID-19 PARA PREVENIR A DOENÇA DO CORONAVÍRUS 2019 (COVID-19)
(January 3, 2022)
12 years of age and older
Português (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУ О ВАКЦИНАХ COMIRNATY (мРНК-ВАКЦИНЕ ПРОТИВ COVID-19) И ВАКЦИНЕ PFIZER-BIONTECH COVID-19 ДЛЯ ПРЕДОТВРАЩЕНИЯ ЗАБОЛЕВАНИЯ КОРОНАВИРУСНОЙ ИНФЕКЦИЕЙ 2019 (COVID-19)
(January 3, 2022)
12 years of age and older
Русский (Russian)
FACT SHEET NG IMPORMASYON SA BAKUNA PARA SA MGA TANGGAP AT CAREGIVERS TUNGKOL SA COMIRNATY (COVID-19 VACCINE, mRNA)AT BAKUNA NA PFIZER-BIONTECH COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19)
(January 31, 2022)
12 years of age and older
Tagalog (Tagalog)
QABUL QILUVCHILAR VA PARVARISH QILUVCHILAR UCHUN COMIRNATY (COVID-19 Vaksina, mRNA) VA PFIZER-BIONTECH COVID-19 VAKSINASI KORONAVIRUS 2019 (COVID-19) KASALLIGINI OLDINI OLISH UCHUN Vaksina HAQIDA MA`LUMOT VARAQASI
(January 3, 2022)
12 years of age and older
O'zbek (Uzbek)
TỜ DỮ KIỆN THÔNG TIN VỀ VẮC XIN DÀNH CHO NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ COMIRNATY (VẮC XIN COVID-19, mRNA)VÀ VẮC XIN PFIZER-BIONTECH COVID-19 ĐỂ PHÒNG NGỪA BỆNH CORONAVIRUS 2019 (COVID-19)
(January 31, 2022)
12 years of age and older
Tiếng Việt (Vietnamese)
Content current as of:
02/16/2022
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