The FDA has announced the approval of the first-ever vaccine for respiratory syncytial virus (RSV), called Arexvy. The adjuvanted RSV prefusion F protein-based vaccine is specifically designed

to prevent lower respiratory tract infections in adults aged 60 and over.

Until now, no vaccine has been available to protect against RSV infection, which can be a common and potentially life-threatening issue for older adults, particularly those with underlying health conditions. According to the CDC, RSV infections are responsible for the hospitalization of an estimated 60,000 to 160,000 older adults in the US each year, with 6,000 to 10,000 deaths associated with the highly contagious virus in this group.

The approval was granted following the positive results of the phase III AReSVi-006 trial, which involved 24,960 adults over the age of 60 who were randomized to receive a single dose of the prefusion F protein vaccine or a placebo.

Vaccine efficacy reached 82.6% against lower respiratory tract illness and 94.1% against severe cases. The vaccine will be available ahead of the 2023/2024 RSV season, and the CDC’s Advisory Committee on Immunization Practices is set to provide guidance on its appropriate use in June. GSK, the developer of the vaccine, has committed to conducting a post-marketing study to assess for the risk of Guillain-Barré syndrome and acute disseminated encephalomyelitis. Photo by The U.S. Food and Drug Administration, Wikimedia commons.