FDA approves RSV vaccine for older adults

FDA approved GSK’s respiratory syncytial virus (RSV) vaccine (Arexvy) for adults aged 60 years and older.

CDC is expected to announce its approval for the GSK vaccine in June, and the company anticipates the vaccines will be available in pharmacies, clinics, and other health care sites this fall. GSK has not yet released a price, but insurance companies usually pay for much of the cost of many vaccines.

A recent study published in NEMJ found that GSK’s vaccine was nearly 83% effective in preventing lower respiratory tract illness in adults ages 60 years and older.

In March, an FDA advisory panel reviewed data from trials for two RSV vaccines designed for older adults: one developed by GSK and another by Pfizer. The panel advised FDA to approve both vaccines.

According to data provided to the FDA panel, two individuals in the trial who received the Pfizer vaccine and one individual who received the GSK vaccine developed Guillain-Barré syndrome 2 days after the vaccines were administered.

RSV causes roughly 6,000 to 10,000 deaths annually in adults ages 65 years and older and at least 60,000 annual hospitalizations in that age group. It is also a leading cause of death among children globally.