FDA to attach rare autoimmune disease warning to J&J COVID-19 vaccine label

The FDA is planning to issue a new warning about Johnson & Johnson's COVID-19 vaccine, as reports of rare cases of Guillain-Barré syndrome are emerging among the shot's recipients, a senior FDA official told Politico.

Guillain-Barré syndrome is a rare neurological disorder in which the immune system attacks part of the nervous system.

Among the 12.8 million people who have received Johnson & Johnson's COVID-19 vaccine in the U.S., about 100 preliminary reports of Guillain-Barré syndrome have emerged.

The FDA and CDC's response will communicate that while there is a small risk associated with receiving Johnson & Johnson's COVID-19 vaccine, the benefits outweigh the risks.

Johnson & Johnson said July 12 it is in talks with the FDA and other regulators about the reports of Guillain-Barré syndrome. 

"The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree," the drugmaker said.

The recent development comes three months after the FDA and CDC recommended the U.S. pause its use of Johnson & Johnson's COVID-19 vaccine while they reviewed reports of rare but serious blood clots in people who've received the shot. The pause was lifted 10 days later, when the agencies decided to resume the shot's use with a warning label stating the risk of rare but potentially dangerous blood clots. 

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars