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The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020

• PMID: 33332292
• PMCID: PMC7745957
• DOI: 10.15585/mmwr.mm6950e2

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Sara E Oliver et al. MMWR Morb Mortal Wkly Rep. 2020.

• PMID: 33332292
• PMCID: PMC7745957
• DOI: 10.15585/mmwr.mm6950e2

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On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,^† using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.^§ The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP's interim recommendation for allocating initial supplies of COVID-19 vaccines (2). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.

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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.

• 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.

  Wallace M, Woodworth KR, Gargano JW, Scobie HM, Blain AE, Moulia D, Chamberland M, Reisman N, Hadler SC, MacNeil JR, Campos-Outcalt D, Morgan RL, Daley MF, Romero JR, Talbot HK, Lee GM, Bell BP, Oliver SE. Wallace M, et al. MMWR Morb Mortal Wkly Rep. 2021 May 21;70(20):749-752. doi: 10.15585/mmwr.mm7020e1. MMWR Morb Mortal Wkly Rep. 2021. PMID: 34014913 Free PMC article.

• 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.

  Woodworth KR, Moulia D, Collins JP, Hadler SC, Jones JM, Reddy SC, Chamberland M, Campos-Outcalt D, Morgan RL, Brooks O, Talbot HK, Lee GM, Bell BP, Daley MF, Mbaeyi S, Dooling K, Oliver SE. Woodworth KR, et al. MMWR Morb Mortal Wkly Rep. 2021 Nov 12;70(45):1579-1583. doi: 10.15585/mmwr.mm7045e1. MMWR Morb Mortal Wkly Rep. 2021. PMID: 34758012 Free PMC article.

• Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2021.

  Dooling K, Gargano JW, Moulia D, Wallace M, Rosenblum HG, Blain AE, Hadler SC, Plumb ID, Moline H, Gerstein J, Collins JP, Godfrey M, Campos-Outcalt D, Morgan RL, Brooks O, Talbot HK, Lee GM, Daley MF, Oliver SE. Dooling K, et al. MMWR Morb Mortal Wkly Rep. 2021 Sep 24;70(38):1344-1348. doi: 10.15585/mmwr.mm7038e2. MMWR Morb Mortal Wkly Rep. 2021. PMID: 34555007 Free PMC article.

• The importance of genomic analysis in cracking the coronavirus pandemic.

  Zella D, Giovanetti M, Cella E, Borsetti A, Ciotti M, Ceccarelli G, D'Ettorre G, Pezzuto A, Tambone V, Campanozzi L, Magheri M, Unali F, Bianchi M, Benedetti F, Pascarella S, Angeletti S, Ciccozzi M. Zella D, et al. Expert Rev Mol Diagn. 2021 Jun;21(6):547-562. doi: 10.1080/14737159.2021.1917998. Epub 2021 Apr 28. Expert Rev Mol Diagn. 2021. PMID: 33849359 Free PMC article. Review.

• Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.

  Malden DE, Gee J, Glenn S, Li Z, Mercado C, Ogun OA, Kim S, Lewin BJ, Ackerson BK, Jazwa A, Weintraub ES, McNeil MM, Tartof SY. Malden DE, et al. Vaccine. 2023 Jan 9;41(2):315-322. doi: 10.1016/j.vaccine.2022.10.079. Epub 2022 Nov 3. Vaccine. 2023. PMID: 36351861 Free PMC article.

1. 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; 2020. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-dise...
2. 1. Dooling K, McClung N, Chamberland M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for allocating initial supplies of COVID-19 vaccine—United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1857–9. 10.15585/mmwr.mm6949e1 - DOI - PMC - PubMed
3. 1. Advisory Committee on Immunization Practices. ACIP meeting information. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://www.cdc.gov/vaccines/acip/meetings/index.html
4. 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
5. 1. Vaccines and Related Biological Products Advisory Committee. Vaccines and Related Biological Products Advisory Committee December 10, 2020, meeting: sponsor briefing document. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. https://www.fda.gov/media/144246/download

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