Advisory Panel Endorses Pfizer RSV Vaccine for Older Adults
WASHINGTON — A panel of advisors to the Food and Drug Administration narrowly voted on Tuesday to endorse an experimental vaccine from Pfizer to protect older adults against the highly contagious lower respiratory tract ailment RSV.
The advisors voted 7-4 on two questions, the first being whether the vaccine was safe, and the second on whether it was effective.
Pfizer told the panel the vaccine was up to 85.7% effective at preventing a full-blown case with three or more symptoms.
But members still expressed reservations about the vaccine’s “important potential risk” — Guillain-Barré syndrome.
Two adults among the 20,000 vaccine recipients in Pfizer’s phase 3 clinical trial developed symptoms consistent with the rare neurological disorder within nine days of receiving the shot.
The FDA panel is also reviewing another proposed RSV vaccine from GlaxoSmithKline.
It is scheduled to review and vote on GSK’s shot, which is also designed to prevent respiratory disease in adults 60 or older, on Wednesday.
The recommendations are non-binding and an FDA decision on the vaccines is expected by May, well ahead of RSV’s normal winter surge.
Once the FDA acts, the Centers for Disease Control and Prevention will weigh in. It’s the last agency that must give its blessing to the vaccines before they are made available to the public.
RSV is a flu-like illness that increases in severity with age. According to the CDC, it is responsible for an estimated 177,000 hospitalizations and 14,000 deaths per year among adults 65 or older.
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