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. 2021 May 21;70(20):749-752.
doi: 10.15585/mmwr.mm7020e1.

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years - United States, May 2021

Megan Wallace, Kate R Woodworth, Julia W Gargano, Heather M Scobie, Amy E Blain, Danielle Moulia, Mary Chamberland, Nicole Reisman, Stephen C Hadler, Jessica R MacNeil, Doug Campos-Outcalt, Rebecca L Morgan, Matthew F Daley, José R Romero, H Keipp Talbot, Grace M Lee, Beth P Bell, Sara E Oliver

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years - United States, May 2021

Megan Wallace et al. MMWR Morb Mortal Wkly Rep. .

Abstract

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. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged ≥16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,§ using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥12 years under an EUA is interim and will be updated as additional information becomes available.

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Conflict of interest statement

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

References

    1. Food and Drug Administration. Pfizer-BioNTech COVID-19 vaccine emergency use authorization. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-dise...
    1. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep 2020;69:1922–4. 10.15585/mmwr.mm6950e2 - DOI - PMC - PubMed
    1. Advisory Committee on Immunization Practices. ACIP meeting information. Atlanta, GA: US Department of Health and Human Services, CDC; 2021. https://www.cdc.gov/vaccines/acip/meetings/index.html
    1. Advisory Committee on Immunization Practices. Advisory Committee on Immunization Practices (ACIP): GRADE (grading of recommendations, assessment, development and evaluation). Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://www.cdc.gov/vaccines/acip/recs/grade
    1. Food and Drug Administration. Pfizer-BioNTech COVID-19 vaccine. EUA amendment review memorandum. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/media/148542/download

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