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Centers for Disease Control and Prevention
Summary of Proposed Clinical Considerations for RSV
Vaccines
June 21, 2023
ACIP Older Adult RSV Vaccine Session
Amadea Britton, MD
Michael Melgar, MD
Overview of clinical considerations
▪Shared clinical decision -making based on risk assessment among
adults aged 60 –64 years
▪Timing of RSV vaccination for the 2023 –2024 RSV season
▪Coadministration of RSV vaccines with other vaccines
▪Persons with immunocompromising conditions
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Clinical consideration: Shared clinical decision -making
based on risk assessment among adults aged 60 –64 years
The decision about whether or not to vaccinate
an individual may be informed by:
•Best available evidence of who may
benefit
•An individual’s characteristics, values, and
preferences
•Health care provider’s clinical discretion
•Characteristics of the vaccine being
considered
3Source: CDC. ACIP Shared Clinical Decision -Making Recommendations. Website: https://www.cdc.gov/vaccines/acip/acip -scdm -faqs.html .
Last updated February 10, 2020. Accessed June 13, 2023. For shared clinical
decision -making
recommendations
there is no default.
If shared clinical decision -making is recommended adults who may
be at higher risk of RSV disease include persons with:
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Immune
compromise
Endocrine disorders
such as diabetes
Hematologic
disorders
Chronic cardiovascular
diseases such as congestive
heart failure and coronary
artery disease
Residents of nursing
homes and other long -
term care facilities
Neurologic disorders
Chronic lung diseases
such as COPD and
asthma
Kidney and liver
disorders
Other underlying conditions or
factors that the provider
determines might increase the
risk of severe respiratory illness
If shared clinical decision -making is recommended adults who may
be at higher risk of RSV disease include persons with:
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Immune
compromise
Endocrine disorders
such as diabetes
Hematologic
disorders
Chronic cardiovascular
diseases such as congestive
heart failure and coronary
artery disease
Residents of nursing
homes and other long-
term care facilities
Neurologic disorders
Chronic lung diseases
such as COPD and
asthma
Kidney and liver
disorders
Other underlying conditions
or factors that the provider
determines might increase the
risk of severe respiratory illness
Clinical consideration: Timing of RSV vaccination for
the 2023 –2024 RSV season
6RSV vaccination is currently approved and recommended as a
single dose.
Optimally, vaccination of eligible adults should occur before
the onset of increased RSV activity in the community.
The timing of the onset, peak, and decline of RSV activity
varies each year, and RSV seasonality during the COVID -19
pandemic deviated from prior seasons.
7RSV Hospitalizations in adults aged ≥65 years by season:
RSV-NET 2017 –2023
COVID -19 pandemic affected RSV
seasonality in 2020 -21, 2021 -22,
and 2022 -23
RSV-NET: unpublished data. Surveillance for 2017 -18 through 2019 -20 seasons were conducted from October –April; for 2020 -21 and 2021 -22 surveillance was conducted continuously from
October –September. Data shown for 2022 -23 season is from October –December 2022. 050100150200250300
40424446485052 2468101214161820222426283032343638Weekly RSV hospitalizations
MMWR Week
2017-18 2018-19 2019-20 2020-21 2021-22 2022-23January
Clinical consideration: Timing of RSV vaccination for
the 2023 –2024 RSV season
8Given this
variability the
ideal time to start
vaccinating
cannot be
predicted in
advance of the
2023-2024 RSV
season.Providers should
therefore offer
RSV vaccination
as soon as
vaccine supply
becomes
available.Providers should
continue to offer
RSV vaccination
throughout the
RSV season to
eligible adults
who remain
unvaccinated .There are
insufficient data
at this time to
determine the
need for
revaccination.
Clinical consideration: Coadministration of RSV
vaccines with other vaccines
9In accordance with General Best Practice Guidelines for
Immunization, coadministration of RSV vaccines with other
adult vaccines is acceptable.*
*ACIP Timing and Spacing Guidelines for Immunization | CDCThis includes giving RSV vaccines simultaneously with
seasonal influenza vaccines, COVID -19 vaccines,
pneumococcal vaccines, Td/Tdap, and recombinant zoster
vaccine (Shingrix) .
Data on immunogenicity of coadministration of RSV
vaccines with other vaccines
•There are currently limited data available on immunogenicity of
coadministration of RSV vaccines and other vaccines.
•In general, coadministration of RSV and seasonal influenza
vaccines met non -inferiority criteria for immunogenicity.*
•However, RSV and influenza antibody titers were generally
somewhat lower with coadministration.
•Additional studies on immunogenicity of coadministration of RSV
with other adult vaccines are in process.
10* Pre -specified non -inferiority criteria for immune responses were met across trials, with the exception of the FluA /Darwin H3N2 strain
after simultaneous administration of RSVPreF3 vaccine ( Arexvy by GSK) and adjuvanted quadrivalent inactivated influenza vaccine.
Reactogenicity and safety of coadministration of RSV
vaccines with other vaccines
•Coadministration of multiple vaccines at the same visit may increase reactogenicity.
•Only coadministration of RSV and influenza vaccines have clinical trial data available.
Evidence is mixed on whether there may be increased reactogenicity with
coadministration of RSV and influenza vaccines.
•Data are lacking on coadministration of other vaccines that might be recommended
for people in this age group, such as COVID -19 vaccines, pneumococcal vaccines,
Td/Tdap, and the recombinant zoster vaccine (Shingrix by GSK) which contains the
same adjuvant as RSVPreF3 vaccine ( Arexvy by GSK).
•Post -licensure safety monitoring of coadministration of RSV vaccines with other
vaccines will further inform coadministration guidance.
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Clinical consideration: RSV vaccines and persons with
immunocompromising conditions
12Persons with
immunocompromising conditions
are recommended to receive the
RSV vaccine under shared clinical
decision -making given the
potential for significant benefit.Adults with immunocompromising
conditions are at risk of severe RSV -
associated disease and death.
They may benefit from RSV vaccination
but were not included in the clinical
trials so efficacy in this population is
unknown.
These individuals, including those
receiving immunosuppressive therapy,
may have a diminished immune
response to RSV vaccination.
For more information, contact CDC
1-800-CDC-INFO (232- 4636)
TTY: 1- 888- 232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
Acknowledgements:
Michael Melgar
Lauren Roper
Hannah Rosenblum
Melinda Wharton
Tara Anderson
Lisa Grohskopf
David ShayTom Shimabukuro
Karen Broder
Mila Prill
Anne Hause
Fiona Havers
Meredith McMorrow
Jefferson Jones
Katherine Fleming -DutraAndrew Kroger
Manisha Patel
Sarah Meyer
Neil Murthy
Patricia Wodi
Sara Oliver