CDC Vaccine Panel to Review Nerve Disorder Tied to J&J Shot
(Bloomberg) -- Covid-19 vaccine safety, including the possible risks from a rare immune-system disorder, will be the focus of an advisory panel meeting scheduled by the U.S. Centers for Disease Control and Prevention on July 22.
The announcement by the CDC comes a day after the fact sheet for Johnson & Johnson’s Covid-19 shot was revised by federal regulators to warn about a “small possible risk” for Guillain-Barré Syndrome, in which the immune system attacks the nerves. The Advisory Committee on Immunization Practices, or ACIP, includes medical and public health experts that advise the agency on vaccine use and safety.
The New Brunswick, New Jersey-based drugmaker’s shares fell less than 1 percent to $169.33 at 1:43 p.m. in New York
In a statement Monday, the Food and Drug Administration said it was adding the warning after 100 reports of Guillain-Barré Syndrome among people who had received the shot. Roughly 12.8 million Americans have been given the one-dose vaccine. Ninety five of the cases required hospitalization and one person died.
An agency spokesperson said the purpose of the advisory panel meeting would be to “hear the latest information on vaccine safety, including GBS, and updated clinical considerations for Covid-19 vaccines.”
The CDC said the Guillain-Barré cases were seen mostly in men over the age of 50 about two weeks after being immunized, however the data was insufficient to be able to say definitively it had caused the illness.
Between 3,000 and 6,000 people a year develop Guillain-Barré Syndrome, according to the FDA, and most fully recover from it. The agency said it has been seen at a higher rate with certain vaccines, including those for seasonal flu and shingles.
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