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 flu-like 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.
The incidence of Guillain-Barre is about 1.5 to 3 cases for 100,000 adults over age 60 in the US annually, according to the FDA. The FDA has called Guillain-Barre syndrome an "important potential risk" of Pfizer and recommended the company conduct a safety study for further evaluation of Guillain-Barre syndrome and other immune-mediated demyelinating conditions after potential vaccine approval, which the company has agreed to. GSK has said they will closely monitor cases after approval.
"This is a disease with incidence 0.1 in 100,000 usually, the majority being in children and then a scatter in young adults. So two cases in elders within three to four weeks post-vaccine is highly anomalous from a statistical standpoint," said Dr. Hana El Sahly, the FDA advisory committee chair, who voted against the GSK shot based on its safety profile but in favor based on efficacy.
"I think the data does support the effectiveness of this vaccine, it's just the population was underrepresented by people who could most benefit from the vaccine," Griffin said of Pfizer's clinical trial.
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