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The advisory committee on immunization practices' interim recommendation for use of Pfizer-Biontech Covid-19 vaccine in children aged 5­11 years: United States, november 2021
MMWR recomm. rep ; 70(45): 1579-1583, Nov. 12, 2022. tab
Article in En | BIGG | ID: biblio-1397007
Responsible library: BR1.1
ABSTRACT
The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle­formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 vaccine is also recommended for adolescents aged 12­15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 µg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥12 years in the United States.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5­11 years, administered as 2 doses (10 µg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5­11 years for the prevention of COVID-19. To guide its deliberations regarding recommendations for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework§ and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.¶ The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5­11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5­11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community transmission of SARS-CoV-2.
Subject(s)

Full text: 1 Collection: 05-specialized Database: BIGG Main subject: Immunization Programs / COVID-19 / BNT162 Vaccine Type of study: Guideline Language: En Journal: MMWR recomm. rep Year: 2022 Document type: Article

Full text: 1 Collection: 05-specialized Database: BIGG Main subject: Immunization Programs / COVID-19 / BNT162 Vaccine Type of study: Guideline Language: En Journal: MMWR recomm. rep Year: 2022 Document type: Article
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