The FDA will require GSK and Pfizer to include a warning about the risk of Guillain-Barré syndrome (GBS) on the labels of their RSV vaccines, Arexvy and Abrysvo, respectively. This decision was made after a postmarketing study showed an increased risk of GBS within 42 days of vaccination. The FDA estimates nine cases of GBS per million doses of Abrysvo and seven cases per million doses of Arexvy in adults 65 and older. Although a causal relationship hasn't been established, the FDA notes that the benefits of the vaccines still outweigh the risks. GSK reports that over 9 million people have received Arexvy with an acceptable safety profile.

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