The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020
Sara E Oliver, Julia W Gargano, Mona Marin, Megan Wallace, Kathryn G Curran, Mary Chamberland, Nancy McClung, Doug Campos-Outcalt, Rebecca L Morgan, Sarah Mbaeyi, José R Romero, H Keipp Talbot, Grace M Lee, Beth P Bell, Kathleen Dooling, Sara E Oliver, Julia W Gargano, Mona Marin, Megan Wallace, Kathryn G Curran, Mary Chamberland, Nancy McClung, Doug Campos-Outcalt, Rebecca L Morgan, Sarah Mbaeyi, José R Romero, H Keipp Talbot, Grace M Lee, Beth P Bell, Kathleen Dooling
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.
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
- 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.
- 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
- Advisory Committee on Immunization Practices. ACIP meeting information. Atlanta, GA: US Department of Health and Human Services, CDC; 2020.
- 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.
- 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.
- Vaccines and Related Biological Products Advisory Committee. Vaccines and Related Biological Products Advisory Committee December 10, 2020, meeting: FDA briefing document. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020.
Source: PubMed