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  1. Coronavirus (COVID-19) | CBER-Regulated Biologics

Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Authorized For Individuals 6 Months through 11 Years of Age

 
Pfizer-BioNTech Fact Sheets Fact Sheet Translations Vacunas contra el COVID-19

On August 22, 2024, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to include the 2024-2025 formula. The Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) includes a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19.

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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 (2024-2025 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 previous dose of any Pfizer BioNTech COVID-19 Vaccine that is no longer authorized for use in the United States: Two doses of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) are administered. The first dose of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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 or more previous doses of any Pfizer BioNTech COVID-19 Vaccine that is no longer authorized for use in the United States: A single dose of Pfizer-BioNTech COVID 19 Vaccine (2024-2025 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 (2024-2025 Formula). If previously vaccinated with any COVID-19 vaccine that is no longer authorized for use in the United States, 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 with an age appropriate dose and dosing schedule. At least one dose should be with a COVID-19 vaccine (2024-2025 Formula).

Pfizer-BioNTech COVID-19 Fact Sheets and Materials

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)

Federal Register Notices

Translations of the Fact Sheet for Recipients and Caregivers
 

受种人和照护者情况说明书：关于具有紧急使用授权（EUA），用于预防6个月至11岁儿童感染 2019年冠状病毒病（ Covid-19）的辉瑞生物技术COVID-19疫苗（2024-2025配方）
(August 22, 2024)		 中文 (Chinese, Simplified)
생후 6개월-11세의 코로나바이러스감염증 2019(코로나19) 예방을 위해 긴급 사용 승인(EUA)된 PFIZER-BIONTECH 코로나19 백신(2024-2025 포뮬러) 접종자 및 보호자를 위한 팩트 시트
(August 22, 2024)		 한국어 (Korean)
HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA CONTRA EL COVID-19 DE PFIZER-BIONTECH (FÓRMULA 2024-2025) QUE CUENTA CON AUTORIZACIÓN DE USO DE EMERGENCIA (EUA) PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) EN PERSONAS DE 6 MESES A 11 AÑOS DE EDAD
(August 22, 2024)		 Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA TUNGKOL SA PFIZER-BIONTE CH COVID-19 VACCINE (2024-2025 NA PORMULA) NA MAYROONG AWTORISASYON SA PANG-EMERHENSIYANG PAGGAMIT (EMERGENCY USE AUTHORIZATION, EUA) UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) NG MGA INDIBIDWAL NA 6 NA BUWAN HANGGANG 11 TAONG GULANG
(August 22, 2024)		 Tagalog (Tagalog)
TỜ THÔNG TIN DÀNH CHO NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC VỀ VẮC-XIN COVID-19/VI-RÚT CORONA PFIZER-BIONTECH (CÔNG THỨC 2024-2025) ĐƯỢC CẤP PHÉP SỬ DỤNG KHẨN CẤP (EUA) ĐỂ PHÒNG NGỪA BỆNH DO VI-RÚT CORONA 2019 (COVID-19/VI-RÚT CORONA) Ở TRẺ TỪ 6 THÁNG ĐẾN 11 TUỔI
(August 22, 2024)		 Tiếng Việt (Vietnamese)

 

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