FDA Finds Rare Neurological Disorder Is ‘Potential Risk’ With Pfizer RSV Vaccine

• FDA Finds Rare Neurological Disorder Is ‘Potential Risk’ With Pfizer RSV Vaccine
  by Tom Ozimek, https://www.theepochtimes.com/health
  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 the rare neurological disorder 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.”
  –
  Two people in their 60s who received the RSV vaccine were diagnosed with Guillain-Barré syndrome in a phase 3 trial, which involved 20,000 recipients of the vaccine. There were no instances of the neurological disorder in people who received a placebo.
  –
  One of the people who experienced the illness made a full recovery after three months and another was showing improvement after half a year.
  –
  read more.

end