BQ Journal Vol 53 - Q4 2023 - 28

Morbidity and Mortality Weekly Report
in this age group, such as COVID-19 vaccines; pneumococcal
vaccines; adult tetanus, diphtheria, and pertussis vaccines; and
the recombinant zoster vaccine (the recombinant zoster vaccine
and GSK's RSV vaccine contains the same adjuvant). When
deciding whether to coadminister other vaccines with an RSV
vaccine, providers should consider whether the patient is up
to date with currently recommended vaccines, the feasibility
of the patient returning for additional vaccine doses, risk for
acquiring vaccine-preventable disease, vaccine reactogenicity
profiles, and patient preferences. Postlicensure efficacy and
safety monitoring of coadministered RSV vaccines with other
vaccines will further direct guidance.
Precautions and Contraindications
As with all vaccines, RSV vaccination should be delayed for
persons experiencing moderate or severe acute illness with or
without fever (precaution). RSV vaccines are contraindicated
for and should not be administered to persons with a history of
severe allergic reaction, such as anaphylaxis, to any component
of the vaccine (30,31).
Reporting of Vaccine Adverse Events
Adverse events after vaccination should be reported to the
Vaccine Adverse Event Reporting System (VAERS). Reporting
is encouraged for any clinically significant adverse event
even if it is uncertain whether the vaccine caused the event.
Information on how to submit a report to VAERS is available
at https://vaers.hhs.gov/index.html or by telephone at
1-800-822-7967.
Future Research and Monitoring Priorities
CDC will monitor adverse events, including cases of GBS,
ADEM, and other inflammatory neurologic events after RSV
vaccination through VAERS and the Vaccine Safety Datalink
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/
vsd/index.html). CDC will also prioritize estimating vaccine
effectiveness against RSV-associated hospitalization. These data
will be evaluated by CDC and ACIP as soon as they are available.
According to FDA postmarketing requirements and commitments,
GSK will conduct a study evaluating risk for GBS,
ADEM, and atrial fibrillation after vaccination with RSVPreF3
(18). Pfizer will conduct two studies, one evaluating risk for
GBS and a second evaluating risk for atrial fibrillation after
vaccination with RSVpreF (19). Pfizer will also evaluate the
safety and immunogenicity of a second RSVpreF dose in a
subset of participants in the main phase 3 trial; GSK will
evaluate safety, immunogenicity, and efficacy of RSVPreF3
revaccination as part of its main phase 3 trial.
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US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | July 21, 2023 | Vol. 72 | No. 29
Diagnostics I Pharmaceuticals I DxRx Solutions I Continuing Education I News
BIOTHERAPEUTICS
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Summary
What is already known about this topic?
Respiratory syncytial virus (RSV) causes substantial morbidity
and mortality in older adults. In May 2023, the Food and Drug
Administration approved the first two vaccines for prevention
of RSV lower respiratory tract disease (LRTD) for use in adults
aged ≥60 years.
What is added by this report?
For both vaccine products, vaccination with a single RSV
vaccine dose demonstrated moderate to high efficacy in
preventing symptomatic RSV-associated LRTD among adults
aged ≥60 years. On June 21, 2023, the Advisory Committee on
Immunization Practices recommended that persons aged
≥60 years may receive a single dose of RSV vaccine, using
shared clinical decision-making.
What are the implications for public health practice?
RSV vaccination might prevent substantial morbidity in older
adults at risk for severe RSV disease; postmarketing surveillance
for safety and effectiveness will direct future guidance.
Acknowledgments
Voting members of the Advisory Committee on Immunization
Practices (in addition to listed authors): Lynn Bahta, Minnesota
Department of Health; Beth P. Bell, University of Washington;
Oliver Brooks, Watts HealthCare Corporation; Wilbur H. Chen,
University of Maryland School of Medicine; Sybil Cineas, Warren
Alpert Medical School of Brown University; Matthew F. Daley, Kaiser
Permanente Colorado; Grace M. Lee, Stanford University School
of Medicine; Jamie Loehr, Cayuga Family Medicine; 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.
Corresponding author: Michael Melgar, media@cdc.gov.
1Coronavirus and Other Respiratory Viruses Division, National Center for
Immunization and Respiratory Diseases, CDC; 2Vanderbilt University School
of Medicine, Nashville, Tennessee; 3Drexel University College of Medicine,
Philadelphia, Pennsylvania; 4Harvard Medical School, Boston, Massachusetts.
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.
ACIP Work Group for Prevention of RSV in Adults
Chair: Camille N. Kotton, Harvard Medical School; ACIP
Members: H. Keipp Talbot, Vanderbilt University School of Medicine;
Sarah S. Long, Drexel University College of Medicine; Consultants:
Robert L. Atmar, Baylor College of Medicine; Doug Campos-Outcalt,
University of Arizona; Helen Y. Chu, University of Washington;
Peter D. Donofrio, Vanderbilt University Medical Center; Marie
R. Griffin, Vanderbilt University Medical Center; Cynthia LuceroObusan,
Veterans Health Administration, Public Health National
Program Office; Rebecca L. Morgan, McMaster University; Tracy
J. Ruckwardt, National Institute of Allergy and Infectious Diseases;

https://vaers.hhs.gov/index.html https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html

BQ Journal Vol 53 - Q4 2023

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