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FDA says Guillain-Barre syndrome is 'important potential risk' of Pfizer's RSV vaccine

February 27, 2023

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Two adults in their 60s who received Pfizer’s RSV vaccine during a clinical trial were later diagnosed with Guillain-Barre syndrome, reports the FDA. Noting that GBS is "an important potential risk," the agency has asked Pfizer to conduct a safety study if the shot is approved, according to FDA vaccine committee briefing documents released Friday. The 2 confirmed cases were among 19,942 vaccine recipients in Pfizer’s Phase 3 clinical trial.

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