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  1. Coronavirus Disease 2019 (COVID-19)

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

May 17, 2022: FDA expands eligibility for Pfizer-BioNTech COVID-19 Vaccine booster dose to children 5 through 11 years. View press release.

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:

  • 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 5 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 4 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 4 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
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

Fact Sheet / FAQs Vaccine Recipient Group Last Updated
For Healthcare Providers 12 years of age and older, purple cap (must dilute) May 17, 2022
For Healthcare Providers 12 years of age and older, gray cap (no dilution)  May 17, 2022
For Healthcare Providers 5 - 11 years of age, orange cap (must dilute) May 17, 2022
For Recipients and Caregivers 12 years of age and older May 17, 2022
For Recipients and Caregivers 5 - 11 years of age May 17, 2022
Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine All February 16, 2022

Pfizer-BioNTech Regulatory Information

Information Date
Letter of Authorization (Reissued) May 17, 2022
Letter Granting EUA Amendment April 26, 2022
Letter Granting EUA Amendment April 13, 2022
Decision Memorandum March 28, 2022
Letter Granting EUA Amendment January 31, 2022
Decision Memorandum Addendum January 6, 2022
Decision Memorandum December 30, 2021
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 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
(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
(March 29, 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
(March 29, 2022) 
12 years of age and older 中文 (Chinese, Simplified)
 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
(March 29, 2022) 
12 years of age and older 한국어 (Korean)
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)
(March 29, 2022) 
12 years of age and older Tagalog (Tagalog)
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)
(March 29, 2022) 
12 years of age and older Tiếng Việt (Vietnamese)

 

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