FDA adds new warning to J&J COVID-19 vaccine

The Food and Drug Administration (FDA) is adding a label on Johnson & Johnson's COVID-19 vaccine, warning that it has been linked to rare cases of Guillain-Barré syndrome (GBS), a neurological disorder in which the body's immune system mistakenly attacks part of its nervous system.

There have been 100 preliminary reports following vaccination after approximately 12.5 million doses administered, FDA said in a statement. Of these reports, 95 of them were serious and required hospitalization. There was one reported death.

The cases have largely occurred about two weeks after vaccination and mostly in men, many aged 50 and older, the CDC said in a statement. The cases are rare, "but do likely indicate a small possible risk of this side effect following this vaccine," the CDC said.

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The CDC added that available data do not show a similar pattern with mRNA vaccinesafter over 321 million doses administered in the United States. This agency said its vaccine advisory committee will discuss the issue at an upcoming meeting. 

The FDA noted that while the available evidence suggests an association between the Johnson & Johnson vaccine and increased risk of Guillain-Barré, “it is insufficient to establish a causal relationship."

GBS itself is rare, affecting only about 3,000 to 6,000 people every year. The exact cause is not known, but most cases usually start a few days or weeks following a respiratory or gastrointestinal viral infection.

Some vaccines have also been shown to cause GBS in rare instances, such as the seasonal influenza shot and a vaccine to prevent shingles.

While GBS comes on rapidly over days to weeks and the person usually recovers, other disorders develop slowly and can linger or recur.Symptoms include major muscle weakness on both sides of the body, coordination problems and unsteadiness, as well as pricking sensations on the hands and feet. In the most serious cases, paralysis can occur.  

The FDA noted that the vaccine is still safe and effective, and the known and potential benefits clearly outweigh the known and potential risks. 

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Nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people, and the CDC emphasized the risk of severe adverse events after COVID-19 vaccination remains rare.

The warning is the latest blow to the Johnson & Johnson vaccine, which was supposed to be an important part of the U.S. vaccination effort. But usage has lagged and the vaccine has been plagued by problems.  

The CDC and FDA paused use of the vaccine for more than a week in April after it was linked to rare and potentially life-threatening blood clots.

The company has also suffered from production problems at its only U.S. manufacturing plant. 

The warning could complicate the Biden administration's efforts to combat vaccine hesitation and skepticism amid the rapidly spreading delta variant, but at least one expert said he was not concerned.

"I don’t think this will have much of an impact on the uptake of this vaccine," said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia. "It’s still a very very rare event."

—Updated at 6:28 p.m.