Pfizer RSV Vaccine for Older Adults is Backed by FDA Panel

Pfizer could soon be the first to offer an RSV vaccine to adults ages 60 and older if the vaccine is fully approved by the Food Drug and Administration and the Centers for Disease Control and Prevention.

Advisers from the FDA on Tuesday voted 7-4 to approve the country's first RSV vaccine based on its safety and effectivness against the respiratory virus. One adviser abstained from voting, according to the Associated Press.

Some panelits shared their concerns as there was not enough data recorded on high-risk groups and severe outcomes. Concerns were also around the vaccine's potential association with Guillain-Barré syndrome, or GBS, a rare neurological disorder that damages nerve cells and causes muscle weakness or paralysis.

According to an FDA briefing document released before the meeting, the most common side effects among older people were fatigue, headache, pain at the injection site and muscle pain. The document also highlighted the potential risk of GBS.

One man in the trial developed Guillain-Barré after he received the vaccine, and a woman developed Miller Fisher syndrome, a rare nerve disease related to Guillain-Barré.

However, the single-dose shot was shown to reduce the risk of illness from respiratory syncytial virus by almost 86%, according to a Pfizer trial in August 2022.

FDA advisers will again meet Wednesday to evaluate a second RSV vaccine, GlaxoSmithKline, for older adults. Data published this month in the New England Journal of Medicine showed the shot lowered the risk of symptomatic illness by 83% and of severe illness by 94% in people ages 60 and up.