FDA Approves First RSV Vaccine

FDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and older, according to an agency press release.

FDA based its approval on analysis of data from an ongoing, randomized, placebo-controlled clinical study in individuals aged 60 and older. The study, which had 12,500 participants receive the vaccine and 12,500 receive placebo, showed that the vaccine reduced the risk of developing RSV-associated LRTD by 82.6% and severe RSV-associated LRTD by 94.1%. Data from the first RSV season of the study was made available to FDA, but participants will remain in the study through three RSV seasons to assess the duration of effectiveness and safety, as well as the effectiveness of repeat vaccines.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects [FDA’s] continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

Results from two other studies were also considered. One of these studies saw two patients develope acute disseminated encephalomyelitis (ADEM), one of whom died. In the other, a single patient developed Guillain-Barré syndrome. According to the release, FDA is requiring GSK to conduct a post-marketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition to this, GSK has independently committed to assess atrial fibrillation in the post-marketing study

Source: FDA