FDA Requires Safety Labeling Changes for Abrysvo and Arexvy Vaccines

According to a Jan. 7 announcement, the FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals.

FDA is now requiring each manufacturer to include a new warning about the risk for Guillain-Barré syndrome (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine.

The announcement said, “The Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section:

• Abrysvo - The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with Abrysvo.
• Arexvy - The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Arexvy.

GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.