The Food and Drug Administration (FDA) said two people who received Pfizer’s respiratory syncytial virus (RSV) vaccine during a clinical trial were subsequently diagnosed with a rare neurological disorder known as Guillain-Barre syndrome.
Briefing documents (pdf) released on Feb. 24 ahead of an upcoming meeting of the Vaccines and Related Biological Products Advisory Committee flagged the two cases of the neurological disorder and said 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 said in the documents. “Therefore, [Guillain-Barre] is being considered an important potential risk.”…
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