The Food and Drug Administration (FDA) stated that two older adults who received Pfizer’s respiratory syncytial virus (RSV) vaccine during a clinical trial were subsequently diagnosed with a rare neurological disorder known as Guillain-Barré syndrome.
Briefing documents (pdf) released on Feb. 24 ahead of this week’s meeting of the Vaccines and Related Biological Products Advisory Committee flagged the two cases of the disorder and stated that Pfizer’s vaccine poses a potential risk.
“Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine,” the FDA stated in the documents. “Therefore, [Guillain-Barré] is being considered an important potential risk.”…