2021 BQ Journal Vol 42 - 30

Morbidity and Mortality Weekly Report
Early Release / Vol. 69

December 20, 2020

The Advisory Committee on Immunization Practices' Interim Recommendation
for Use of Moderna COVID-19 Vaccine - United States, December 2020
Sara E. Oliver, MD1; Julia W. Gargano, PhD1; Mona Marin, MD1; Megan Wallace, DrPH1,2; Kathryn G. Curran, PhD1; Mary Chamberland, MD1,3;
Nancy McClung, PhD1; Doug Campos-Outcalt, MD4; Rebecca L. Morgan, PhD5; Sarah Mbaeyi, MD1; José R. Romero, MD6; H. Keipp Talbot, MD7;
Grace M. Lee, MD8; Beth P. Bell, MD9; Kathleen Dooling, MD1

On December 18, 2020, the Food and Drug Administration
(FDA) issued an Emergency Use Authorization (EUA) for the
Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX,
Inc; Cambridge, Massachusetts), a lipid nanoparticleencapsulated, nucleoside-modified mRNA vaccine encoding
the stabilized prefusion spike glycoprotein of SARS-CoV-2,
the virus that causes coronavirus disease 2019 (COVID-19)
(1). This vaccine is the second COVID-19 vaccine authorized
under an EUA for the prevention of COVID-19 in the United
States (2). Vaccination with the Moderna COVID-19 vaccine
consists of 2 doses (100 μg, 0.5 mL each) administered
intramuscularly, 1 month (4 weeks) apart. On December 19,
2020, the Advisory Committee on Immunization Practices
(ACIP) issued an interim recommendation* for use of the
Moderna COVID-19 vaccine in persons aged ≥18 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.§ Use of all COVID-19 vaccines authorized under
an EUA, including the Moderna COVID-19 vaccine,
should be implemented in conjunction with ACIP's interim
recommendations for allocating initial supplies of COVID-19
vaccines (3). The ACIP recommendation for the use of the
Moderna COVID-19 vaccine under EUA is interim and will
be updated as additional information becomes available.
* On December 19, 2020, ACIP voted 11-0 in favor of the interim
recommendation for use of the Moderna COVID-19 vaccine. Three ACIP
members recused themselves because of participation in clinical trials and/or
other studies involving companies producing COVID-19 vaccines.
† https://www.cdc.gov/vaccines/acip/recs/grade/downloads/ACIP-evidence-recframe-508.pdf.
§ https://www.cdc.gov/vaccines/acip/recs/grade/about-grade.html.

Since June 2020, ACIP has convened 10 public meetings
to review data on the epidemiology of COVID-19 and the
potential use of COVID-19 vaccines, including the Moderna
COVID-19 vaccine (4). Within the EtR Framework, ACIP
considered the importance of the public health problem
of COVID-19, as well as resource use, benefits and harms,
patients' values and preferences, acceptability, feasibility, and
equity for the Moderna COVID-19 vaccine. To inform the
EtR Framework, the COVID-19 Vaccines Work Group,
comprising experts in infectious diseases, vaccinology, vaccine
safety, public health, and ethics, held 28 meetings to review
COVID-19 surveillance data, evidence for vaccine efficacy
and safety, and implementation considerations for COVID-19
vaccines, including the Moderna COVID-19 vaccine. After
a systematic review of available data, the Work Group used
the GRADE approach to assess the certainty of evidence for
outcomes related to the vaccine, rated on a scale of 1 (high certainty) to 4 (very low certainty) (5). Work Group conclusions
regarding certainty of evidence for the Moderna COVID-19
vaccine were presented to ACIP at public meetings.
The body of evidence for the Moderna COVID-19
vaccine was primarily informed by one large, randomized, double-blind, placebo-controlled Phase III clinical
trial that enrolled approximately 30,000 participants aged
18-95 years (median  =  52 years) (6-9). Interim findings
from this clinical trial, using data from participants with a
median of 2 months of follow-up, indicate that the Moderna
COVID-19 vaccine efficacy after 2 doses was 94.1%
(95% confidence interval  =  89.3%-96.8%) in preventing
symptomatic, laboratory-confirmed COVID-19 among persons without evidence of previous SARS-CoV-2 infection,
which was the primary study endpoint. High efficacy (≥86%)
was observed across age, sex, race, and ethnicity categories and

U.S. Department of Health and Human Services
Centers for Disease Control and Prevention

Diagnostics I Pharmaceuticals I DxRx Solutions I Continuing Education I News
A Henry Schein Publication

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https://www.cdc.gov/vaccines/acip/recs/grade/downloads/ACIP-evidence-rec-frame-508.pdf https://www.cdc.gov/vaccines/acip/recs/grade/downloads/ACIP-evidence-rec-frame-508.pdf https://www.cdc.gov/vaccines/acip/recs/grade/about-grade.html

2021 BQ Journal Vol 42

Table of Contents for the Digital Edition of 2021 BQ Journal Vol 42

Table of Contents
2021 BQ Journal Vol 42 - Cover1
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2021 BQ Journal Vol 42 - Table of Contents
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2021 BQ Journal Vol 42 - Cover4
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