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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
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11 12 2021
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Source: MMWR Morb Mortal Wkly Rep. 70(45):1579-1583
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Alternative Title:MMWR Morb Mortal Wkly Rep
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Description: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 U.S.* 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 Rec.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.
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Pubmed ID:34758012
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Pubmed Central ID:PMC8580204
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Volume:70
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Issue:45
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