University of Oklahoma Health Sciences Center

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Author/s:

Oliver, Sara E., Gargano, Julia W., Marin, Mona, Wallace, Megan, Curran, Kathryn G., Chamberland, Mary, McClung, Nancy, Campos-Outcalt, Doug, Morgan, Rebecca L., Mbaeyi, Sarah, Romero, Jose R., Talbot, H.K., Lee, Grace M., Bell, Beth P., Dooling, Kathleen

Date Added:

January 21, 2021

Journal/Publication:

Morbidity and Mortality Weekly Report

Publisher:

CDC

Publication Date:

December 18, 2020

Issue:

Volume:

Pages:

1922-1924

URL:

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

Type:

Public Health Announcements

Format:

Article

DOI (1):

10.15585/mmwr.mm6950e2

PMID (1):

33332292

Keywords

immunizations

Pfizer–BioNTech mRNA vaccine

Pfizer

COVID-19

MeSH

RPR Commentary

Summary and conclusions of the ACIP regarding the Pfizer COVID-19 vaccine based upon the RCT data available from Pfizer. James W. Mold, MD, MPH

Abstract

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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