TY - JOUR T1 - The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021. AU - Woodworth,Kate R, AU - Moulia,Danielle, AU - Collins,Jennifer P, AU - Hadler,Stephen C, AU - Jones,Jefferson M, AU - Reddy,Sujan C, AU - Chamberland,Mary, AU - Campos-Outcalt,Doug, AU - Morgan,Rebecca L, AU - Brooks,Oliver, AU - Talbot,H Keipp, AU - Lee,Grace M, AU - Bell,Beth P, AU - Daley,Matthew F, AU - Mbaeyi,Sarah, AU - Dooling,Kathleen, AU - Oliver,Sara E, Y1 - 2021/11/12/ PY - 2021/11/10/entrez PY - 2021/11/11/pubmed PY - 2021/11/16/medline SP - 1579 EP - 1583 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 45 N2 - The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, 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 12-15 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 5-11 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 5-11 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 5-11 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 5-11 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. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/34758012/The_Advisory_Committee_on_Immunization_Practices'_Interim_Recommendation_for_Use_of_Pfizer_BioNTech_COVID_19_Vaccine_in_Children_Aged_5_11_Years___United_States_November_2021_ DB - PRIME DP - Unbound Medicine ER -