FDA Approves First-Ever RSV Vaccine After Brutal 2022 Season
GlaxoSmithKline’s Arexvy is now approved for people ages 60 and older to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV).
RSV is a common respiratory infection that typically causes mild, cold-like symptoms, but can lead to serious lung infections for those most vulnerable, like children, older adults and those with underlying health conditions.
Each year in the U.S., RSV leads to between 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 and older, the FDA said in a release.
The study that led to Arexvy’s approval found that the vaccine reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing a severe RSV-associated respiratory disease by 94.1%.
The most common side effects among those in the trial were injection-site pain, fatigue, muscle pain, headache and joint stiffness or pain, the FDA said.
The Centers for Disease Control and Prevention is expected to provide specific recommendations for GlaxoSmithKline and its vaccine in June, according to an ABC report, but the company expects it will have enough vaccines to meet demand ahead of RSV season in the fall and winter.
Last year, the U.S. had an alarmingly bad RSV season, which some are attributing to lapsed Covid-19 pandemic health measures that had helped keep the public generally healthier and safe from RSV and the common cold. Between October and November in 2021, the CDC recorded 42,000 cases of RSV; in the same period in 2022, that number had swelled to 126,000, according to Contemporary Pediatrics.
The FDA is ahead of its time line, as it was expected to approve at least one RSV vaccine this year by the fall. The first attempt to create an RSV vaccine was in the 1960s, though it was unsuccessful and led to severe and lethal cases of lung inflammatory response in infants. Forbes previously reported 11 potential RSV vaccines were being studied in trials—4 for infants and 7 for adults. GSK, whose vaccine was approved, was racing drugmakers Pfizer and Moderna to get the first-approved RSV vaccine. CNBC reported that Moderna is still planning to file an application for FDA approval in the first half of this year.
“Today marks a turning point in our effort to reduce the significant burden of RSV. . . . Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries,” said Tony Wood, chief scientific officer at GSK, in a press release.
May 4, 2023