FDA Approves First RSV Vaccine for Older Adults
On May 3, the Food and Drug Administration (FDA) approved the first respiratory syncytial virus (RSV) vaccine for use in the U.S. FDA approved the drug,
Arexvy from GSK, for prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older. RSV is a highly contagious virus that is a common cause of lower respiratory tract disease in older adults and can cause life-threatening pneumonia and bronchiolitis. In late-stage clinical trials the drug was more than 80 percent effective at preventing moderate cases of RSV and more than 90 percent effective at preventing severe disease. The FDA’s approval is based on GSK following participants through one RSV season in a Phase III study to test the vaccine’s durability. The side effects of the vaccine were generally mild, but the FDA is requiring GSK to conduct a post marketing study to assess the risks for more severe side effects, like Guillain-Barre syndrome, which were very rare in the trials.
Pfizer has also asked the FDA to approve its vaccine candidate for RSV for adults 60 years and older. In early March the FDA’s Vaccine and Related Biological Products Advisory Committee recommended both the Pfizer and GSK RSV vaccinations for adults 60 years and older, but had some concerns about the Pfizer vaccine’s durability and potential side effects. The FDA plans to make a decision on Pfizer’s vaccine by the end of the month.