The Mercury News
Advisers favor RSV vaccines for older adults
Over the course of a two-day meeting, vaccine advisers to the U.S. Food and Drug Administration voted in favor of approval for RSV vaccines for adults over the age of 60. The vaccine candidates, made by Pfizer and GlaxoSmithKline, could become the world's first approved vaccines against the common virus.
On Wednesday, committee members voted 10-2 in support of the safety and unanimously in support of the effectiveness of GSK's vaccine for the prevention of lower respiratory tract disease caused by RSV among older adults.
For Pfizer's shot, committee members voted on Tuesday 7-4 with one abstention that there is adequate data to support the vaccine's safety and effectiveness.
The FDA, which typically follows the committee's recommendations, is expected to decide on approval of the vaccines in May, ahead of RSV's typical winter surge.
Respiratory syncytial virus is a highly contagious virus that causes flulike illness in people of all ages that increases in severity with age. According to the US Centers for Disease Control and Prevention, RSV is responsible for an estimated 177,000 hospitalizations and 14,000 deaths per year among adults 65 or older.
GSK's RSV vaccine candidate for older adults was 82.6% effective in preventing lower respiratory tract disease defined by either two or more symptoms or and one or more signs or three or more symptoms. The shot was 94.1% effective at preventing severe disease.
The Pfizer vaccine was 66.7% effective at preventing moderated lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing illness with three or more symptoms, according to Pfizer.