FDA Mandates Nerve Damage Warnings for 2 RSV Vaccines

Respiratory syncytial virus (RSV) activity is currently deemed to be ‘very high’ in many parts of the United States, according to CDC.

A man wearing facemask and shield walks past the Pfizer headquarters in New York, on March 11, 2021. Kena Betancur/AFP/Getty Images

The U.S. Food and Drug Administration (FDA) ordered two respiratory syncytial virus (RSV) vaccine manufacturers to include a potentially paralytic side effect warning related to nerve damage on product labels.

The manufacturers, GSK and Pfizer, manufacturing Arexvy and Abrysvo vaccines respectively, must now include a warning stating a risk of Guillain-Barre syndrome (GBS) following vaccination, according to a Jan. 7 statement from the agency.