Outside panel advises FDA to approve Pfizer RSV vaccine for older adults

An external panel that advises the United States Food and Drug Administration narrowly voted to endorse a new Pfizer vaccine for respiratory syncytial virus (RSV) for older adults.

The move is the first step toward the FDA approving a vaccine that prevents severe RSV in the lower respiratory systems of adults aged 65 and older. While RSV typically leads to cold or flu-like symptoms that resolve within a few days, for older people and infants it can be severe, sometimes requiring hospitalization. The virus results in 60,000-160,000 hospitalizations among adults 65 years and older per year in the United States, according to the Centers for Disease Control and Prevention.

The 7-4 vote confirmed the panel’s opinion that sufficient data exists to prove the vaccine is safe and effective at preventing RSV in older adults. One panel member abstained from the Wednesday vote. The votes against approving the vaccine were heavily based on some instances of Guillain-Barre syndrome appearing within days of taking the vaccine in trials. Two adults in Pfizer’s trials experienced GBS after taking the RSV vaccine.

Guillain-Barre syndrome, according to the CDC, is a bodily response that occurs when the immune system begins harming the nerves. It can lead to muscle weakness, and in some cases, paralysis. The same advisory panel also voted this week to advance an RSV vaccine manufactured by GlaxoSmithKline (GSK) meant for individuals 60 years and older.