The FDA sees a potential risk and has asked Pfizer to conduct a safety study on Guillain-Barre after a potential approval, which the company said it would do.
Eli Lilly recruits Black patients for Alzheimer trial as drugmakers seek more diversity in clinical studies
"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 agency said. But GSK, in its briefing document, said a Guillain-Barre diagnosis was not confirmed due to the absence of exam results and because there was no information on whether alternative causes were investigated. The patient's case was considered resolved after six months, the company said.The Centers for Disease Control and Prevention's committee of independent vaccine advisors grappled with the three cases of Guillain-Barre syndrome during a meeting open to the public Thursday. Dr.
Although Pfizer and GSK have asked the FDA to approve their respective vaccines for people ages 60 and older, the CDC workgroup generally favored a recommendation for seniors ages 65 and older. The CDC advisory committee did not vote on any recommendations for the RSV vaccines this week.
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