2021 BQ Journal Vol 42 - 32

Early Release

University Law School; Oliver Brooks, National Medical Association;
Matthew Daley, Institute for Health Research, Kaiser Permanente
Colorado; Jillian Doss-Walker, Indian Health Service; Marci Drees,
Society for Healthcare Epidemiology of America; Jeffrey Duchin,
Infectious Diseases Society of America; Doran Fink, Food and Drug
Administration; Sandra Fryhofer, American Medical Association;
Jason M. Goldman, American College of Physicians; Michael Hogue,
American Pharmacists Association; Denise Jamieson, American
College of Obstetricians and Gynecologists; Jeffery Kelman,
Centers for Medicare & Medicaid; David Kim, U.S. Department
of Health and Human Services; Kathy Kinlaw, Center for Ethics,
Emory University; Susan Lett, Council of State and Territorial
Epidemiologists; Kendra McMillan, American Nurses Association;
Kathleen Neuzil, Center for Vaccine Development and Global
Health, University of Maryland School of Medicine; Sean O'Leary,
American Academy of Pediatrics; Christine Oshansky, Biomedical
Advanced Research and Development Authority; Stanley Perlman,
Department of Microbiology and Immunology, University of Iowa;
Marcus Plescia, Association of State and Territorial Health Officials;
Chris Roberts, National Institutes of Health; William Schaffner,
National Foundation for Infectious Diseases; Rob Schechter,
Association of Immunization Managers; Kenneth Schmader,
American Geriatrics Society; Bryan Schumacher, Department of
Defense; Jonathan Temte, American Academy of Family Physicians;
Matthew Tunis, National Advisory Committee on Immunization
Secretariat, Public Health Agency of Canada; Thomas Weiser, Indian
Health Service; Matt Zahn, National Association of County and City
Health Officials; Rachel Zhang, Food and Drug Administration.

Summary
What is already known about this topic?
On December 18, 2020, the Food and Drug Administration
issued an Emergency Use Authorization (EUA) for the Moderna
COVID-19 vaccine.
What is added by this report?
On December 19, 2020, after a transparent, evidence-based
review of available data, 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.
What are the implications for public health practice?
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.

vaccination providers report vaccination administration errors,
serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or
death after administration of COVID-19 vaccine under EUA.
Reporting by anyone who gives or receives a COVID-19 vaccine is encouraged for any clinically significant adverse event,
whether or not it is clear that a vaccine caused the adverse event.
Information on how to submit a report to VAERS is available
at https://vaers.hhs.gov/index.html or 1-800-822-7967. In
addition, CDC has developed a new, voluntary smartphonebased tool, v-safe, that uses text messaging and web surveys to
provide near real-time health check-ins after patients receive
COVID-19 vaccination. The CDC/v-safe call center follows
up on reports to v-safe that indicate a medically significant
health impact to collect additional information for completion
of a VAERS report. Information on v-safe is available at https://
www.cdc.gov/vsafe. Information on how to use both reporting
systems is included in the EUA Fact Sheet (11).

Corresponding author: Sara E. Oliver, yxo4@cdc.gov.
1CDC COVID-19 Response Team; 2Epidemic Intelligence Service, CDC;
3 General Dynamics Information Technology, Falls Church, Virginia;
4University of Arizona, College of Medicine, Phoenix, Arizona; 5Department

of Health Research Methods, Evidence, and Impact, Hamilton, Ontario,
Canada; 6Arkansas Department of Health; 7Vanderbilt University School of
Medicine, Nashville, Tennessee; 8Stanford University School of Medicine,
Stanford, California; 9University of Washington, Seattle, Washington.

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.

Acknowledgments

References

Voting members of the Advisory Committee on Immunization
Practices: Robert L. Atmar, Baylor College of Medicine; Kevin A.
Ault, University of Kansas Medical Center; Lynn Bahta, Minnesota
Department of Health; Henry Bernstein, Zucker School of Medicine
at Hofstra/Northwell Cohen Children's Medical Center; Sharon E.
Frey, Saint Louis University Medical School; Paul Hunter, City of
Milwaukee Health Department; Veronica V. McNally, Franny Strong
Foundation; Katherine A. Poehling, Wake Forest School of Medicine;
Pablo J. Sánchez, The Research Institute at Nationwide Children's
Hospital; Peter Szilagyi, University of California, Los Angeles.
Members of the Advisory Committee on Immunization Practices
COVID-19 Vaccines Work Group: Edward Belongia, Center for
Clinical Epidemiology & Population Health, Marshfield Clinic
Research Institute; Dayna Bowen Matthew, George Washington

1. Food and Drug Administration. Moderna 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-disease-2019covid-19/Moderna-covid-19-vaccine
2. Food and Drug Administration. Pfizer 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-disease-2019covid-19/pfizer-biontech-covid-19-vaccine
3. Advisory Committee on Immunization Practices. COVID-19 ACIP
Vaccine Recommendations. Atlanta, GA: US Department of Health and
Human Services, CDC; 2020. https://www.cdc.gov/vaccines/hcp/aciprecs/vacc-specific/covid-19.html

MMWR / December 20, 2020 / Vol. 69

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

https://vaers.hhs.gov/index.html https://www.cdc.gov/vsafe https://www.cdc.gov/vsafe https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/Moderna-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/Moderna-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/Moderna-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html

2021 BQ Journal Vol 42

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