Federal health regulators are expected to add a new warning to the Johnson & Johnson coronavirus vaccine about a serious, but rare side effect in which the body’s immune system attacks its own nerves, according to reports.
About 100 preliminary reports of the disorder, called Guillain-Barré syndrome, have been detected out of 12.8 million doses that have been administered, The Associated Press reported, citing a Monday statement from the Centers for Disease Control and Prevention. The cases have mostly affected men, many 50 years and older, and appear about two weeks following vaccination.
The CDC said it would seek the advice of an independent board of vaccine experts and ask them to review the issue at an upcoming meeting.
Despite the newest blow to the one-shot vaccine, officials are expected to declare the Johnson & Johnson shot safe and to stress that its benefits outweigh potential risks, people familiar with the matter told The Washington Post.
The anticipated warning is the third major stumbling block for the vaccine. The company had to discard millions of vaccine doses because of contamination at the Emergent BioSolutions plant in Baltimore that was producing the vaccines. In April, federal officials temporarily suspended the use of the vaccine because of reports of rare, but serious blood clots linked to the shot. The FDA and CDC lifted the pause 10 days later after conducting a safety review, determining that the benefits of the vaccine exceed the cons.
Guillain-Barré syndrome can cause muscle weakness and sometimes paralysis. Symptoms can last for a few weeks to several years. While most people recover, some suffer permanent nerve damage, and in some cases, the syndrome is fatal.
An estimated 3,000-6,000 people in the U.S. develop Guillain-Barré syndrome each year, the CDC says. Most people with the condition had a respiratory illness or diarrhea several weeks before developing symptoms. Infections such as the flu, Epstein Barr virus and Zika virus have been known to trigger the syndrome. In rare cases, people have developed the condition after receiving certain vaccines.
• This story is based in part on wire service reports.
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