FDA to Add Warning Related to Guillain-Barré Syndrome on Johnson & Johnson Vaccine

The FDA is soon expected to announce that they will be adding a warning to the Johnson & Johnson COVID-19 vaccine label that will state a link to a rare adverse event, the autoimmune condition called Guillain-Barré syndrome.

The vaccine was developed by Janssen Pharmaceuticals, a company based in Belgium that is owned by Johnson & Johnson. In a statement, the United States Centers for Disease Control and Prevention (CDC) announced that there have been 100 preliminary reports of the syndrome after administration of the Janssen vaccine. The events have been reported largely around 2 weeks after vaccination, mostly in men, of which the majority were aged 50 years or older.

Guillain-Barré syndrome is a rapid-onset of muscle weakness that is caused by the immune system attacking nerves. The condition usually occurs at a rate of around 60 to 120 cases per week, and the cause is not fully understood.

While most people who develop the syndrome fully recover, some individuals have permanent nerve damage, with people over 50 years of age being at the greatest risk. Although, officials are expected to state that the benefits of the vaccine still clearly outweigh the potential risks.

The CDC stated that the cases of Guillain-Barré will be discussed as part of an upcoming meeting of advisers.