FDA Mandates Guillain-Barré Syndrome Warning for Pfizer and GSK RSV Vaccines

FDA Warning:
The FDA has required Pfizer and GSK to add a warning about Guillain-Barré syndrome to the prescribing information for their RSV vaccines, Abrysvo and Arexvy, respectively135.

Postmarketing Study Findings:
An observational study using Medicare data found an increased risk of Guillain-Barré syndrome within 42 days of vaccination, with nine excess cases per million doses of Abrysvo and seven per million doses of Arexvy among individuals aged 65 and older1.

Insufficient Evidence for Causality:
While the study suggests an association between the vaccines and Guillain-Barré syndrome, the FDA notes that available evidence is insufficient to establish a causal relationship1.

Label Updates:
The prescribing information for both vaccines has been revised to include warnings about the potential increased risk of Guillain-Barré syndrome during the 42 days following vaccination135.

Background:
Guillain-Barré syndrome is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis1.

Sources:

1. https://respiratory-therapy.com/disorders-diseases/infectious-diseases/rsv/fda-mandates-guillain-barre-syndrome-warning-two-rsv-vaccines/

3. https://www.pharmalive.com/gsk-pfizer-rsv-shots-required-to-carry-guillain-barre-syndrome-warnings/

5. https://www.empr.com/news/rsv-vaccine-labeling-updated-with-guillain-barre-syndrome-warning/