FDA Raises Guillain-Barre Monitoring on RSV Vaccine

FDA has proposed that Pfizer include Guillain-Barré syndrome (GBS) and other immune-mediated demyelinating conditions in a pharmacovigilance plan (PVP) if the company’s BLA for Abrysvo (RSVpreF) is approved. The company is seeking an indication for preventing acute respiratory disease and lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV) in individuals 60 years of age and older. The safety-related concern was raised in a briefing document released in advance of a 2/28 advisory committee meeting that will discuss and vote on the submission.

Vaccine efficacy (VE) in preventing laboratory-confirmed RSV in those with two or more symptoms was 66.7%, the document says, adding that there were 11 cases in the vaccine group and 33 cases in the placebo group. VE in preventing laboratory-confirmed RSV in those with three or more symptoms was 85.7%, with two cases in the vaccine group and 14 cases in the placebo group.