GSK announced that its respiratory syncytial virus (RSV) vaccine Arexvy (RSVPreF3 OA/GSK3844766A) has been approved by the FDA for the prevention of lower respiratory disease (RSV-LRTD) caused by RSV infection in the elderly. This is the first RSV vaccine approved for global distribution.
The FDA’s approval is predicated on the positive findings of the AReSVi 006 phase III study. This is a global, multicenter, randomized, double-blind, placebo-controlled clinical trial involving 24966 elderly subjects aged 60 and older to evaluate the RSV-LRTD preventive efficacy of single-dose and annual Arexvy (Numb12467) versus placebo (Numb12499). The primary objective of the study was to determine the protective effect of a single dose of Arexvy against RSV during the initial RSV-LRTD epidemic season.
The results showed that the overall vaccine efficacy of Arexvy was 82.6% (96.95% CI:57.9–94.1). The preventive effect against severe RSV-LRTD (defined as at least 2 symptoms) was 94.1% (95% CI:62.4–99.9), and the preventive effect against RSV-A subtype and RSV-B subtype was identical (84.6% vs 80.9%).
In addition, the preventive efficacy of Arexvy was 94.6% (95% CI:65.9–99.9) in the elderly group with complications and 93.8% (95% CI:60.2–99.9) in the 70-79 age group (Numb8974).
In terms of safety, Arexvy has good tolerance and safety. The adverse events (AE) reported in the study were usually mild to moderate and transient, and the most common AE were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), and headache (27.2%).
RSV is the most common cause of lower respiratory tract infection. Both the elderly and infants are susceptible to RSV. According to statistics, about 101,000 children (0–5 years old) and 26,000 adults worldwide died of RSV infection in 2019. However, there are no prevention programmes for all infants and the elderly, and existing treatments are limited to relieving symptoms.