As per agency presentation docs released on Friday, the Food and Drug Administration sees a potential risk of Guillain-Barre syndrome with Pfizer’s RSV vaccination for older persons and has requested the company to conduct a security analysis if the injection is approved this spring.
Out of around 20,000 vaccination participants in the phase 3 trial, two patients in their 60s who got Pfizer’s injection were found to have Guillain-Barre syndrome, as per the FDA documentation. In the placebo group of the trial, those who did not receive the shot—there were no cases.
A rare condition known as Guillain-Barre syndrome, also known as inflammatory neuropathy, occurs when the body’s immune system accidentally attacks the nerves. The National Institutes of Health describe a variety of symptoms, including short-term weakening and finally paralysis. Even in the worst circumstances, most people eventually recover.
In its briefing material, Pfizer stated that there may be more causes for the cases. However, it stated that following a possible approval, a safety study to properly evaluate Guillain-Barre syndrome would be carried out. The business claimed that the trial revealed no safety issues and that the vaccination was well received.