FDA declares that rare neurological disorder Guillain-Barré syndrome (GBS) is an important potential risk of Pfizer’s RSV vaccine; IMO, it's imperative that FDA demand Pfizer perform safety studies

by Paul Alexander

Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine.

FDA wrote: ‘Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine.’

SOURCE:

https://www.fda.gov/media/165623/download

e.g.: