The respiratory syncytial virus vaccine from GlaxoSmithKline was given the green light by the Food and Drug Administration on Wednesday, making it the country’s first officially recognized RSV shot.
Why it matters: The GSK vaccine is authorized for use in adults 60 and older, a group at high risk for RSV. According to the Centers for Disease Control and Prevention, the illness results in up to 160,000 hospitalizations and 10,000 fatalities each year in people 65 and older.
The big picture: Pfizer’s RSV vaccine, a candidate for the same age group, is also anticipated to receive a decision from the FDA.
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.
