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ACIP Adult RSV Work Group Clinical Considerations
RSV vaccination in Adults 50 –59 at increased risk of severe
RSV diseaseDiya Surie, MD
Michael Melgar, MD
Amadea Britton, MD
Co-Leads, Adult RSV Vaccine Work Group
Coronavirus and Other Respiratory Viruses Division (CORVD)
Advisory Committee on Immunization Practices (ACIP)
April 16, 2025National Center for Immunization and Respiratory Diseases
•Licensed products for use in adults aged 50 –59 years at increased risk of
severe RSV disease
•Adults aged 50 –59 years at increased risk of severe RSV disease
•Timing of RSV vaccination for the 2025 –2026 RSV season
•Coadministration of RSV vaccines with other vaccinesOverview
*Pfizer’s Abrysvo is also licensed and recommended for use in pregnancy to prevent RSV LRTD in
infants after birth. No other RSV vaccine should be administered in pregnancy .RSV vaccine FDA licensure for RSV prevention in adults,
as of April 16, 2025
20 30 40 50 60 70 80 90GSK's ArexvyPfizer's Abrysvo*Moderna's mResvia
Age (years)18
Licensure limited to adults at increased risk of
RSV lower respiratory tract disease (LRTD)Licensure is for the general
population of adults aged ≥60 years
*Pfizer’s Abrysvo is also licensed and recommended for use in pregnancy to prevent RSV LRTD in
infants after birth. No other RSV vaccine should be administered in pregnancy .RSV vaccine FDA licensure for RSV prevention in adults,
as of April 16, 2025
20 30 40 50 60 70 80 90GSK's ArexvyPfizer's Abrysvo*Moderna's mResvia
Age (years)18
Licensure limited to adults at increased risk of
RSV lower respiratory tract disease (LRTD)Licensure is for the general
population of adults aged ≥60 yearsIf mResvia gains FDA licensure in high -risk adults 50 –59, it
would be included in an existing recommendation by default
Adults aged 50 –59 years at increased risk of
severe RSV disease
Proposed list of risk factors for the 50 –59 recommendation is
the same as that currently used for the 60 –74 recommendation
Neurological or neuromuscular conditions
causing impaired airway clearance or
respiratory muscle weaknessChronic cardiovascular
disease
Moderate or severe
immunocompromise Diabetes mellitus
complicated by chronic kidney disease,
neuropathy, retinopathy or other end -
organ damage or requiring treatment
with insulin or sodium -glucose
cotransporter -2 (SGLT2) inhibitorSevere obesity
(body mass index
≥40 kg/m2)Chronic lung
or respiratory
disease
End stage renal
disease/dialysis
dependenceChronic liver
diseaseChronic hematologic
conditions
Residence in a
nursing homeOther chronic medical conditions or risk factors that a
provider determines would increase risk of severe disease
due to viral respiratory infection (e.g., frailty)
Britton A, Roper LE, Kotton CN, et al. Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommen dations of the Advisory Committee on Immunization Practices — United States,
2024. MMWR Morb Mortal Wkly Rep 2024;73:696 -702. DOI: http://dx.doi.org/10.15585/mmwr.mm7332e1 .
Includes information on risk of
Guillain -Barré syndrome for the
two subunit vaccines (GSK’s
Arexvy , Pfizer’s Abrysvo )
Current RSV vaccine flyer
for healthcare providers
will be updated with any
new recommendation
https://www.cdc.gov/rsv/media/pdfs/2025/01/355818 -A_RSV_VaccineForOlderAdultsFlyer -01072025 -V9-WEB.pdf
Guidance on the timing of RSV vaccination is
unchanged
▪RSV vaccination should be given ONLY
to adults who have not yet received a
dose of RSV vaccine.
▪It is anticipated that adults may need
additional doses of RSV vaccine in the
future, but ideal revaccination timing
is not yet known. Adults who have already received
a dose of RSV vaccine should NOT
receive another dose at this time. RSV vaccination will have the
most benefit if given in late
summer or early fall .
▪This means from August to
October in most of the United
States.
▪Note this is not a formal seasonal
recommendation for RSV
vaccination. Eligible adults may
continue to receive RSV
vaccination year -round.
Co-administration of RSV vaccines with other
adult vaccines
11•With two exceptions,1,2 pre-specified non -inferiority criteria were met for
simultaneous vaccination, compared with separate administration.
•The Work Group notes our limited understanding of clinical significance of
decreased antibody titers with RSV vaccine co -administration. ACIP previously reviewed results from studies on co -
administration of RSV vaccine with influenza and mRNA
COVID -19 vaccines
1.Simultaneous administ ration of GSK’s Arexvy with adjuvanted influenza vaccine resulted in lower H3N2 hemagglutination inhibition (HAI)
titers, compared with sequential administration. Humoral immune response against influenza A/Darwin H3N2 was also assessed po st-hoc via
microneutralization, which resulted in a geometric mean titer (GMT) ratio similar to the HAI GMT ratio, with a slightly narro wer confidence
interval. Non -inferiority criteria were not specified for post -hoc analyses. Reference: Clark R, et al. Safety and Immunogenicit y of Respiratory
Syncytial Virus Prefusion F Protein Vaccine when Co -administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Olde r Adults: A
Phase 3 Randomized Trial. Clin Infect Dis. 2024 Oct 15;79(4):1088 -1098. https://pubmed.ncbi.nlm.nih.gov/39099085/
2.Simultaneous administration of Moderna’s mResvia with high -dose influenza vaccine resulted in lower RSV -A and RSV -B neutralizing antibody
titers, compared with RSV vaccination alone. Reference: https://www.cdc.gov/acip/downloads/slides -2024 -10-23-24/02 -RSV-Adult -Das-
508.pdf
12•Both vaccines include the same adjuvant system (AS01); adjuvant dose in
Shingrix is twice the dose in Arexvy .
•530 immunocompetent participants aged ≥50 years were randomized 1:1 to
receive either sequential (control group) or simultaneous (intervention
group) vaccination with Arexvy and dose one of Shingrix, followed by
completion of the Shingrix two -dose series.GSK provided results of a co -administration study with
Arexvy and recombinant zoster vaccine (Shingrix)
Reference: Dennis P , et al. Co -administration of the adjuvanted respiratory syncytial virus (RSV) prefusion F protein vaccine (R SVPreF3 OA) with the adjuvanted
recombinant zoster vaccine (RZV) in adults ≥50 years of age. 20th EuGMS Congress. 2024 Sep 18 -20; Valencia, Spain.
13•Immunogenicity non -inferiority criteria were met (upper limit of 2 -sided
95% CI ≤1.5 for GMT [RSV -A or RSV -B neutralization] or GMC [anti -gE] ratio;
ratio calculated as separate administration/simultaneous administration)
-One month after Arexvy administration, GMT ratio:
•RSV-A neutralizing antibodies: 1.14 (95% CI: 0.97, 1.35)
•RSV-B neutralizing antibodies: 0.98 (95% CI : 0.84, 1.15)
-One month after dose two of Shingrix, GMC ratio:
•Anti-gE antibodies: 1.24 (95% CI: 1.0 8, 1.42)GSK provided results of a co -administration study with
Arexvy and recombinant zoster vaccine (Shingrix)
CI: confidence interval, GMT: geometric mean titer, GMC: geometric mean concentration
Reference: Dennis P , et al. Co -administration of the adjuvanted respiratory syncytial virus (RSV) prefusion F protein vaccine (R SVPreF3 OA) with the adjuvanted
recombinant zoster vaccine (RZV) in adults ≥50 years of age. Presented at 20th EuGMS Congress. 2024 Sep 18 -20; Valencia, Spain.
14•No specific safety concerns identified
•Reactogenicity of simultaneous administration overall greater than that
of Arexvy given alone, but more similar to that of Shingrix given alone
•Serious adverse events: 4.9% in simultaneous administration group vs.
2.3% in the sequential administration group, but no clustered imbalance
in any specific organ system or type of adverse event
•No cases of Guillain -Barr é syndrome (GBS) or acute disseminated
encephalomyelitis (ADEM)*GSK provided results of a co -administration study with
Arexvy and recombinant zoster vaccine (Shingrix)
*With total enrollment of 530 participants, this trial was underpowered to detect rare adverse events.
Reference: Dennis P , et al. Co -administration of the adjuvanted respiratory syncytial virus (RSV) prefusion F protein vaccine (R SVPreF3 OA) with the adjuvanted
recombinant zoster vaccine (RZV) in adults ≥50 years of age. 20th EuGMS Congress. 2024 Sep 18 -20; Valencia, Spain.
15•Co-administration of RSV vaccines and other recommended adult vaccines
is common.
•Given the considerable benefits of co -administration and the evidence of
safety of co -administration, the Work Group continues to feel co -
administration is acceptable .1
•In addition, the Work Group looks forward to learning more about an
analysis by Moderna on immunologic correlates of protection for RSV when
peer -reviewed publication is available.Work Group interpretations of co -administration data
1.This language is different from CDC’s General Best Practices Guidelines for Immunization, which states that with limited exce ption,
routine administration of all age -appropriate doses of vaccines simultaneously is recommended for persons for whom no specific
contraindications exist at the time of the visit.
Kroger A, Bahta L, Long S, Sanchez P . General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on
Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/imz -best -practices/ . Updated July 22, 2024; accessed October 22, 2024
16•Whether the patient is up to date with currently recommended vaccines
•The feasibility of the patient returning for additional vaccine doses
•Risk of acquiring vaccine -preventable disease
•Vaccine reactogenicity profiles
•Patient preferencesWhen deciding whether to co -administer other vaccines
with an RSV vaccine, providers may consider:
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
• Adult RSV Vaccine Work Group
• CDC Coronavirus and Other Respiratory Viruses Division
• CDC Immunization Services Division