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U.S. Food and Drug Administration officials recommend monitoring people receiving Pfizer or Moderna’s Covid-19 vaccine shots for possible cases of Bell’s palsy with half of your face hanging.
A 54-page employee report released Tuesday said that more than 30,000 clinical trial participants among Modernas reported four cases of Bell’s palsy. Three of the participants who had Bell’s palsy also received the vaccine instead of a placebo shot. The Pfizer study also reported four cases of Bell’s palsy from around 43,000 participants. All four Bell palsy cases in Pfizer’s study received the vaccine rather than the placebo.
Staff advocating Moderna’s emergency use of the coronavirus vaccine said there was insufficient data to link the cases directly to the shots, but that warranted scrutiny.
Two of the cases of Bell’s palsy in Moderna’s vaccine group have since “resolved”, while one was still ongoing at the time of the report, FDA officials said. The vaccinated participants experienced paralysis between 22 and 32 days after inoculation.
According to the Mayo Clinic, Bell’s palsy causes a sudden freezing or weakness of a person’s facial muscles, which is temporary for most people. The exact cause isn’t known, but it’s thought to result from either a viral infection or swelling and inflammation of the nerve that controls the muscles on one side of your face, the Mayo Clinic said.
“Currently available information is insufficient to establish a causal relationship with the vaccine,” wrote the FDA staff.
The FDA’s Advisory Panel on Vaccines and Related Biological Products meets Thursday to review Moderna’s vaccine. Pfizer approved the vaccine a week ago before the FDA gave formal approval to start distribution on Friday. Health care workers at locations across the United States lined up to receive some of the first injections of Pfizer’s vaccine on Monday.
Dr. Paul Offit, a voting member of the FDA’s Advisory Committee on Vaccines and Related Biological Products, agreed that the condition should be monitored when the vaccine is introduced. He voted last week to recommend Pfizer’s vaccine.
“I’m not rejecting this yet,” he said in an interview with CNBC.
When Merck submitted its data from its rotavirus vaccine study, there were five cases of Kawasaki disease but none in the placebo group. That was “statistically significant” and prompted Merck to change its label to record the cases.
While there was a small imbalance in cases in the vaccine group compared to placebo, the FDA said it was not sure whether the drug contributed to the paralysis “because the number of cases was small and no more than expected in the general population.”
“There were no other notable patterns or numerical imbalances between treatment groups for any particular category of adverse event, including other neurological, neuro-inflammatory and thrombotic events, that would suggest a causal relationship with Moderna’s COVID-19 vaccine,” wrote FDA- Staff in the documents.
The FDA guidelines for Moderna vaccine released Tuesday were similar to recommendations for Pfizer’s vaccine last week. Officials from the U.S. Centers for Disease Control and Prevention said Pfizer’s vaccine didn’t appear to be causing the disease.
Dr. Peter Marks, director of the FDA’s Center for the Evaluation and Research of Biologics, said in an interview with JAMA on Monday that once the vaccines have been administered, the agency can easily and quickly access data on Bell palsy cases.
“Our working hypothesis is that this was just an imbalance in the background rates like we’ve seen in other studies, but we’ll make sure we actually query this to get this question closed,” said Marks.
– CNBC’s Berkeley Lovelace Jr. contributed to this report.