U.S. to Announce New Warning on J&J Coronavirus Vaccine for Guillain-Barré Syndrome

(Reuters)—The U.S. Food & Drug Administration (FDA) is expected to announce a new warning on Johnson & Johnson’s (J&J’s) coronavirus vaccine related to a rare autoimmune disorder, The Washington Post reported on Monday, citing four people familiar with the matter.¹

According to The Post, about 100 preliminary reports of Guillain-Barré syndrome have been detected in the U.S. after vaccination with J&J shot, mostly in men, many of whom were 50 or older. Around 12.8 million people have received the one-dose vaccine in the U.S.

J&J and the FDA were not immediately available for comment.

Guillain-Barré syndrome, in which the body’s immune system attacks the protective coating on nerve fibers, most often follows a bacterial or viral infection.

The condition has been linked in the past to vaccinations—most notably to a vaccination campaign during a swine flu outbreak in the U.S. in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.

Reference

1. McGinley L, Sun LH. FDA adds new warning on Johnson & Johnson vaccine related to rare autoimmune disorder. The Washington Post. 2021 Jul 12.