The Medical Letter on Drugs and Therapeutics
In Brief: RSV Vaccine (Arexvy) for Ages 50-59
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Med Lett Drugs Ther. 2024 Jul 22;66(1707):113-4   doi:10.58347/tml.2024.1707a
Principal Faculty
  • Mark Abramowicz, M.D., President has disclosed no relevant financial relationships.
  • Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
Additional Contributor(s)
  • Amy Faucard, MLS, Associate Editor has disclosed no relevant financial relationships.
Upon completion of this activity, the participant will be able to:
  1. Discuss the use of the RSV vaccine Arexvy in persons 50-59 years old.
 Select a term to see related articles  Abrysvo   Arexvy   mResvia   RSV 

The recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) has now received FDA approval for use in adults 50-59 years old who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. It was previously approved only for adults ≥60 years old.1 Two other RSV vaccines have received FDA approval: Abrysvo, a recombinant vaccine that is licensed for use in adults ≥60 years old and in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants,1 and mResvia, an mRNA vaccine recently licensed for use in adults ≥60 years old that will be available for the 2024-25 RSV season.

RSV DISEASE — RSV typically causes a mild upper respiratory tract infection, but older adults, particularly those with underlying health conditions, have an increased risk of hospitalization due to RSV-associated LRTD. RSV epidemics in the Northern Hemisphere typically occur between October and April, peaking in December or January.

CLINICAL STUDIES — Arexvy has been shown to reduce the incidence of RSV-associated LRTD in adults ≥60 years old for up to 2 RSV seasons (median follow-up 17.8 months).1 FDA approval of Arexvy for the expanded indication was based on the results of an unpublished immunogenicity trial that included 1152 adults 50-59 years old who were randomized to receive Arexvy or placebo; about 50% had chronic medical conditions (pulmonary or cardiovascular disease, diabetes, kidney or liver disease). Persons with immunocompromising conditions were excluded. The trial also enrolled a comparator group of adults ≥60 years old who received the vaccine. Among persons vaccinated with Arexvy, RSV-A and RSV-B neutralizing antibody responses at one month in adults 50-59 years old (with and without chronic medical conditions) were noninferior to those in adults ≥60 years old.2

ADVERSE EFFECTS — In the clinical trial, adverse effects of Arexvy were similar in participants 50-59 years old and ≥60 years old but were reported at slightly higher rates in the younger age group. The most common adverse effects reported in adults 50-59 years old within 4 days of receiving Arexvy were injection-site pain (75.8%), erythema (13.2%) and swelling (10.4%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), and arthralgia (23.4%). Arexvy was not associated with an increased risk of serious adverse events or potential immune-mediated diseases, compared to placebo, within 6 months post vaccination. Inflammatory neurologic events, including Guillain-Barré syndrome, and an increased risk of atrial fibrillation have been reported following vaccination with Arexvy in other trials.

ACIP RECOMMENDATIONS — The CDC Advisory Committee on Immunization Practices (ACIP) has recently updated its recommendations for use of RSV vaccines in older adults. A single dose of RSV vaccine is now recommended for all adults ≥75 years old and for those 60-74 years old at increased risk of severe RSV disease (see Table 1).3 The ACIP has not yet issued a recommendation for RSV vaccination in adults 50-59 years old; an ACIP Work Group has suggested that RSV vaccination is likely to be beneficial in certain adults 50-59 years old at risk of severe RSV disease, but more data are needed.4 For optimal protection, the vaccine should be given before the onset of the RSV season. Administration of an RSV vaccine and other adult vaccines during the same visit is acceptable, but local or systemic reactogenicity could increase.

DOSAGE, ADMINISTRATION, AND COST — Arexvy is given as a single 0.5-mL IM injection. The wholesale acquisition cost (WAC) for one dose is $280.5

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