CDC, FDA investigating possible J&J vaccine link to rare neurological disorder

Federal health officials are looking into “around 100 preliminary reports” of a rare but potentially serious neurological problem in people who have received Johnson & Johnson’s Covid-19 vaccination.

In a statement, the Centers for Disease Control and Prevention said the agency and the Food and Drug Administration are monitoring the reports of Guillain-Barré syndrome, which damages nerve cells and can cause muscle weakness.

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The cases are only linked to the Johnson & Johnson vaccine, not to the Covid-19 vaccines from Pfizer-BioNTech or Moderna, both of which use a different kind of technology.

If confirmed, the 100 cases would represent a tiny fraction — less than 0.001 percent — of the more than 12.8 million Johnson & Johnson doses that have been administered in the United States.

The CDC statement said one of its advisory committees will discuss the possible link in an upcoming meeting.

Any warning label, if warranted, would come from the FDA. The FDA does not need to wait for the CDC advisory meeting to make a decision.

“Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following Covid-19 vaccination very seriously,” the CDC statement read.

The CDC said the cases under investigation “have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.”

Johnson & Johnson said in a statement that the company had been in contact with the FDA “and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination.”

“The chance of having this occur is very low,” the company said, adding that the number of reports are only slightly higher than the number that would normally be expected, regardless of whether an individual had been vaccinated.

The FDA did not immediately respond to requests for comment.

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In April, administration of the Johnson & Johnson shots was paused to investigate very rare blood clots following the vaccine.

That pause has since been lifted, but many of the company’s doses were left untouched and at risk of expiring.

In June, the FDA told the company to discard 60 million doses of vaccine that had been contaminated with ingredients from another vaccine at the Emergent BioSolutions plant in Baltimore.

Guillain-Barré syndrome is rare, affecting an estimated 3,000 to 6,000 people each year in the U.S, typically following a viral or bacterial infection, according to the CDC.

Most people recover fully; however, permanent nerve damage and paralysis are possible. People over age 50 are most at risk.

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