FDA Approves First Vaccine for RSV, a Moment Six Decades in the Making
By Brenda Goodman
On May 3, the U.S. Food and Drug Administration (FDA) approved GSK's single dose respiratory syncytial virus (RSV) vaccine, Arexvy, for patients aged 60 and older. If the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommends the RSV vaccine in June, Arexvy would be available this fall. RSV hospitalizes an estimated 159,000 adults aged 65 and older annually, with an estimated 10,000 to 13,000 deaths among this age group. According to the clinical trial results published in the New England Journal of Medicine, the RSV vaccine was 83% effective at preventing lower respiratory tract disease caused by the virus and 94% effective at preventing severe disease in seniors. Of the three other RSV vaccines in final testing, Pfizer's RSV vaccine is expected to receive FDA approval for seniors by the end of the month.
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