New Vaccines Under Investigation For 'Nervous System Disorder'

Health officials are investigating if there is a link between two new RSV vaccines and Guillain-Barre syndrome.

"Serious neurologic conditions, including Guillain-Barre syndrome, have been reported after RSV vaccination in clinical trials of older adults. It is unclear whether the vaccine caused these events," the CDC writes.

There were two options, one made by Pfizer and the other by GSK. "Two people who received Pfizer's respiratory syncytial virus vaccine during a clinical trial were later diagnosed with Guillain-Barre syndrome, and the US Food and Drug Administration has asked Pfizer to conduct a safety study if the shot is approved, according to agency documents released Friday," CNN reports.

Out of 20,000 vaccine recipients in Pfizer's Phase 3 clinical trial, two Guillain-Barre syndrome cases were confirmed in adults in their 60s. Per CNN:. One person's illness had completely resolved after three months, and another was improving after six months.

"Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine. Therefore, is being considered an important potential risk," the FDA says in the documents, which were released ahead of a meeting of its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, on Tuesday and Wednesday.

The committee is scheduled to discuss and make recommendations on RSV vaccines for adults 60 and older from Pfizer and GSK. Guillain-Barre syndrome is a rare neurological disorder in which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis.

In a briefing document submitted for next week's meetings, Pfizer says that the cases have other possible explanations and that its shot is a "Well-tolerated and safe vaccine, with a benefit-to-risk ratio that is favorable." The company says it will conduct a safety study on Guillain-Barre syndrome if its RSV shot is approved. 

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