FDA updates warning label of J&J vaccine, medical leaders say it’s still safe option

Published: Jul. 13, 2021 at 9:23 PM CDT
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BIRMINGHAM, Ala. (WBRC) - The FDA has updated the label for the Johnson & Johnson COVID vaccine to include a warning of a potential risk of developing a neurological complication.

“This potential connection between the Johnson & Johnson vaccine and this neurological condition called Guillain-Barre Syndrome,” said Dr. Wesley Willeford, Jefferson County Department of Health.

The FDA updated the warning label on the vaccine, but noted it’s not yet clear if the vaccine causes the condition.

Guillain-Barre Syndrome causes the body to attack parts of the immune system which can cause muscle weakness, tingling sensations, and sometimes paralysis. In most cases, symptoms began within 42 days after vaccination. But it is treatable.

“About 70% of people who get it make a full recovery. There are treatments typically given in the hospital which can speed it up,” said Willeford.

Jefferson County public health department leaders say the data still indicates the potential risk is minimal and it is still much better to get vaccinated against COVID-19.

“This is still rare - it’s happened in about 100 cases in 12 million doses given and it’s incredibly rare,” said Willeford. “Something bad happening with the virus is far higher - order of magnitude higher - than with the vaccine.”

Of the 100 reports of the syndrome after the Johnson & Johnson vaccination, 95 cases resulted in hospitalization and one person died. The spokesperson said the CDC’s Advisory Committee says leaders are expected to discuss the matter in an upcoming meeting.

The FDA says it will continue to monitor the situation.

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