RSVPreF3 OA respiratory syncytial virus vaccine in older adults: a profile of its use

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and conflict of interest M. Shirley is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

 RSVPreF3 OA (AREXVY), a respiratory syncytial virus (RSV) subunit vaccine, presents a valuable tool for the prevention of RSV-associated lower respiratory tract disease (LRTD) in older adults. Administered by intramuscular injection, the RSVPreF3 OA vaccine formulation contains the highly conserved RSV fusion protein, stabilised in its trimeric prefusion conformation, adjuvanted with AS01_E. As demonstrated in the pivotal, randomised, placebo-controlled, multinational, phase 3 AReSVi-006 trial, a single dose of RSVPreF3 OA is efficacious in reducing the risk of RSV associated LRTD over three RSV seasons in adults aged ≥ 60 years, with similar levels of efficacy against both RSV A and RSV B subtypes. Of note, high vaccine efficacy was demonstrated for protecting against RSV-associated LRTD in participants with certain co-existing medical conditions who are at higher risk of serious outcomes. Additionally, immunogenicity data support the efficacy of RSVPreF3 OA in adults aged 50–59 years who are at increased risk for RSV disease, with immune responses in adults aged 50–59 years being non-inferior to those in adults aged ≥ 60 years. While RSVPreF3 OA appears to be moderately reactogenic, most reactogenicity events are transient and of mild to moderate intensity. Based on currently available data, the vaccine has an acceptable safety profile. 

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