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                Coronavirus (COVID-19) | CBER-Regulated Biologics

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          Pfizer-BioNTech COVID-19 VaccineCoronavirus (COVID-19) | CBER-Regulated Biologics Pfizer-BioNTech COVID-19 Vaccine
  
  					Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age
	
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    PrintPfizer-BioNTech Fact Sheets Fact Sheet Translations Vacunas contra el COVID-19

On September 11, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to include the 2023-2024 formula. The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) includes a monovalent (single) component that corresponds to the Omicron variant XBB.1.5 of SARS-CoV-2. The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is no longer authorized for use in the United States.

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is authorized for use as follows:

**Individuals 6 months through 4 years of age:**

**Unvaccinated individuals:** Three doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) are administered. The first two doses are administered three weeks apart. The third dose is administered at least 8 weeks after the second dose.
	**Individuals who have received one dose of any Pfizer BioNTech COVID-19 Vaccine, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent:** Two doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) are administered. The first dose of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is administered three weeks after receipt of the previous dose and the second dose is administered at least 8 weeks later.
	**Individuals who have received two to four doses of any Pfizer BioNTech COVID-19 Vaccine, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent:**A single dose of Pfizer-BioNTech COVID 19 Vaccine (2023-2024 Formula) is administered at least 8 weeks after receipt of the last previous dose.**Individuals 5 years through 11 years of age, regardless of vaccination status:**

**A single dose of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula**). If previously vaccinated with any COVID-19 vaccine, administer at least 2 months after receipt of the last previous dose of any COVID-19 vaccine.**Immunocompromised individuals 6 months through 11 years of age:**:

**Complete at least a three-dose series with a COVID-19 vaccine, each dose one month apart.** At least one dose should be with a COVID-19 vaccine (2023-2024 Formula).Pfizer-BioNTech COVID-19 Fact Sheets and Materials

Material
			Audience
			Last UpdatedFact Sheet
			Recipient and Caregiver
			September 11, 2023Fact Sheet
			Healthcare Provider
			December 8, 2023Dear Healthcare Provider Letter
			Healthcare Professionals
			September 11, 2023

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)

Information
			DateGranting Letter
			December 8, 2023Concurrence Letter
			November 15, 2023Decision Memorandum
			September 11, 2023Letter of Authorization (Reissued)
			September 11, 2023

Federal Register Notices

Title
			DateAuthorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability
			January 19, 2021

Translations of the Fact Sheet for Recipients and Caregivers

关于具有紧急使用授权(EUA)的预防2019年冠状病毒疾病(Covid-19)的辉瑞生物技术二价COVID-19疫苗的受种者和照顾者情况说明书
			(September 11, 2023)
			中文 (Chinese, Simplified)코로나바이러스 감염증 2019(코로나19) 예방을 위한 긴급사용승인(EUA)을 받은 화이자-바이오엔테크 코로나19 2가 백신 접종자 및 보호자를 위한 사실 보고서
			(September 11, 2023)
			한국어 (Korean)HOJA DE INFORMACIÓN PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA BIVALENTE CONTRA EL COVID-19 DE PFIZER-BIONTECH QUE CUENTA CON AUTORIZACIÓN DE USO DE EMERGENCIA (EUA) PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19)
			(September 11, 2023)
			Español (Spanish)FACT SHEET PARA SA MGA TAGATANGGAP AT TAGAPAG-ALAGA TUNGKOL SA BAKUNANG PFIZER-BIONTECH PARA SA COVID-19 NA MAY AWTORISASYON PARA SA PANG-EMERHENSYANG PAGGAMIT (EUA) UPANG MAIWASAN ANG SAKIT NA CORONAVIRUS 2019 (COVID-19)
			(September 11, 2023)
			Tagalog (Tagalog)TỜ THÔNG TIN DÀNH CHO NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ VẮC-XIN LƯỠNG TRỊ COVID-19 PFIZER-BIONTECH ĐÃ ĐƯỢC CẤP PHÉP SỬ DỤNG KHẨN CẤP (UEA) ĐỂ PHÒNG NGỪA BỆNH DO VI-RÚT CORONA 2019 (COVID-19)
			(September 11, 2023)
			Tiếng Việt (Vietnamese)

                                                                                  Content current as of:
      12/11/2023
              
              
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