The Food and Drug Administration on Wednesday approved GlaxoSmithKline's vaccine against the respiratory syncytial virus, making it the first authorized RSV shot in the U.S.
Why it matters: GSK's vaccine is approved for adults aged 60 and older, a population that is particularly vulnerable to RSV. The disease causes up to 10,000 deaths and as many as 160,000 hospitalizations for people 65 and up per year, per the Centers for Disease Control and Prevention.
The big picture: The FDA is also expected to make a decision regarding Pfizer's RSV vaccine, a candidate for the same age group.
- Both the Pfizer and GSK shots were endorsed by an agency expert panel that found them to be safe and effective.
What they're saying: "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 the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
By the numbers: Trial data showed the GSK's vaccine was 94% effective at lowering the risk of severe illness and approximately 83% effective at reducing symptomatic infection in adults aged 60 and older.
- Meanwhile, Pfizer's RSV shot was around 86% effective at preventing severe disease.
What else is happening: Children younger than five years old are also vulnerable to RSV. However, the FDA is not currently considering a vaccine candidate for kids and infants.
What's next: The CDC must recommend the vaccine before it can become available to the public.
- The CDC’s Advisory Committee on Immunization Practices is scheduled to meet in late June, though it’s unclear whether the GSK shot will be considered at that time.
