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

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.

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

SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates

Devin Evans — Fri, 13 Nov 2020 06:00:00 +0000

Date Added:

November 13, 2020

Journal/Publication:

Lancet

Publication Date:

October 13, 2020

Issue:

10262

Volume:

396

Pages:

1595-1606

URL:

SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/S0140-6736(20)32137-1

Keywords

PMID (1):

33065034

MeSH

Anitbodies, Monoclonal

A review of what is currently known about the immune response to COVID-19 and its implications for therapy and vaccines. James W. Mold, MD, MPH

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Understanding immune responses to severe acute respiratory syndrome coronavirus 2 is crucial to understanding disease pathogenesis and the usefulness of bridge therapies, such as hyperimmune globulin and convalescent human plasma, and to developing vaccines, antivirals, and monoclonal antibodies. A mere 11 months ago, the canvas we call COVID-19 was blank. Scientists around the world have worked collaboratively to fill in this blank canvas. In this Review, we discuss what is currently known about human humoral and cellular immune responses to severe acute respiratory syndrome coronavirus 2 and relate this knowledge to the COVID-19 vaccines currently in phase 3 clinical trials.

Author/s:

Gregory A., Ovsyannikova , Inna G., Kennedy, Richard B.