FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV Vaccines Abrysvo And Arexvy

(RTTNews) - The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the potential risk of Guillain-Barré Syndrome following vaccination.

The respiratory syncytial virus (RSV) vaccines, Abrysvo, manufactured by Pfizer Inc. (PFE), and Arexvy, manufactured by GlaxoSmithKline Biologicals, were approved in May 2023. Postmarketing observational studies suggest an increased risk of Guillain-Barré syndrome within 42 days following vaccination with each. However, the FDA has reiterated that the benefits of vaccination with Abrysvo and Arexvy continue to outweigh their risks.

Guillain-Barré Syndrome (pronounced (gee-YAH-buh-RAY) is a rare disorder in which the body's immune system attacks nerve cells, causing muscle weakness and sometimes even paralysis.

Respiratory Syncytial Virus, or RSV, is a viral pathogen that causes severe lung infections, including bronchiolitis (infection of small airways in the lungs) and pneumonia (infection of the lungs). It can cause acute lower respiratory tract infections (LRTI) in children under 5 years of age and upper respiratory tract infections in adults. However, in elderly persons, immunocompromised individuals, and those with underlying cardiac or pulmonary conditions, RSV can also lead to life-threatening lower respiratory tract infections.

Pfizer's Abrysvo generated $356 million in sales during the third quarter of 2024, a decrease from $375 million in the same period the previous year. Meanwhile, GlaxoSmithKline's Arexvy reported sales of 188 million pounds in the third quarter of 2024, compared to 700 million pounds in the third quarter of 2023.