FDA To Add Warning Of Rare Autoimmune Disorder To J&J Vaccine: Reports

The Food and Drug Administration is expected to attach a new warning to the Johnson & Johnson COVID-19 vaccine about an increased risk of Guillain-Barré syndrome, a rare neurological disorder. 

Regulators said the risk of recipients developing the autoimmune disorder, which affects the nerves, was low and that the benefits of getting the vaccine against COVID-19 outweighed the risk, The New York Times reported. 

The Centers for Disease Control and Prevention said that about 100 cases of Guillain-Barré had been reported out of nearly 13 million people in the U.S. who got the one-dose Johnson & Johnson vaccine, according to The Washington Post. Cases were primarily reported in men over age 50 and came on about two weeks after vaccination.  

Most people fully recover from Guillain-Barré syndrome, according to the CDC. 

The Johnson & Johnson shot is still 85% effective at preventing severe disease and 100% effective against hospitalization and death, which are the main goals of COVID-19 vaccination.  

The CDC and FDA did not immediately respond to HuffPost’s requests for comment.

The Johnson & Johnson vaccine rollout was temporarily paused earlier this year over concerns about extremely rare blood clots among some recipients. 

Over 184 million people have gotten at least one dose of a COVID-19 vaccine across the U.S. so far, including the Pfizer and Moderna vaccines, which require two doses. 

Coronavirus cases and deaths have plummeted in the U.S. since vaccinations became widely available in the spring, and currently the overwhelming majority of cases are among people who have not been vaccinated.