FDA says Guillain-Barre syndrome is possible risk of Pfizer's RSV vaccine for older adults
Publishing timestamp: 2023-02-24 14:15:30
Summary
The FDA has asked Pfizer to conduct a safety study on Guillain-Barre Syndrome after potential approval of their RSV vaccine for older adults, after two people in their 60s who received the shot were diagnosed with the syndrome. GSK also had a possible case of Guillain-Barre Syndrome in their trials, but the company said there was insufficient evidence to confirm the diagnosis. The FDA and study investigators consider the GSK case to be related to the vaccine. The FDA will review the safety surveillance plan and make recommendations as needed.
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