Guillain-Barre syndrome, or inflammatory neuropathy, is a disorder in which the body’s immune system mistakenly attacks the nerves.
Symptoms can range from bursts of weakness to paralysis, according to the National Institutes of Health. It causes anywhere from 6,000 to 10,000 deaths a year among seniors, though mortality rates tend to vary from season to season.“Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to [the] study vaccine,” said the FDA.
Pfizer, in its briefing document, said the cases have other possible explanations, adding that its shot is a “well-tolerated and safe vaccine, with a benefit-to-risk ratio that is favorable.” The New York-based pharmaceutical company also agreed to conduct a safety study to further assess potential risks of Guillain-Barre syndrome should the vaccine be approved.
The FDA documents were released ahead of a meeting next week of its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee. On Tuesday, they will vote on whether Pfizer’s efficacy and safety data warrants an FDA approval. Pfizer’s vaccine was 85% effective at preventing the lower respiratory tract illness for which it was designed.
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