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U.S. Food and Drug Administration staff recommend monitoring people receiving vaccines against Povizer or Modern Covid-19 for possible cases of Bell’s palsy, saying it’s not necessarily a side effect, but worth it. worth watching it after a handful of participants in a trial have the disease, causing half of the face to fall off.
A 54-page report released Tuesday reported that there were four cases of Bell’s palsy among the more than 30,000 participants in Moderna’s clinical trial. Three of the participants who got Bell’s palsy also received the vaccine instead of a placebo shot. Similarly, the Pfizer trial reported four cases of Bell’s palsy on some 43,000 participants. The four cases of Bell’s palsy at the Pfizer trial got the vaccine and not the placebo.
Staff, who supported the emergency use of Moderna’s coronavirus vaccine, said there was not enough data to link the cases directly to the shots, but justified strict control. Two of Bell’s paralysis cases among Moderna’s vaccine group have been “resolved” since one was still ongoing at the time of the report, according to FDA staff.
Bell’s palsy causes a sudden freeze or weakness in a person’s facial muscles that is temporary for most people, according to the Mayo Clinic. The exact cause is not known, but it is believed to come from a viral infection or swelling and inflammation of the nerve that controls the muscles on one side of the face, the Mayo Clinic said.
“The information currently available is insufficient to determine a causal relationship to the vaccine,” FDA staff wrote.
The FDA’s advisory committee on vaccines and related biological products meets Thursday to review Moderna’s vaccine. A week ago he supported the Pfizer vaccine, before the FDA granted formal authorization on Friday to begin distribution. Health workers lined up in different parts of the United States to receive some of the first injections of the Pfizer vaccine on Monday.
Dr. Paul Offit, a voting member of the FDA Advisory Committee on Vaccines and Related Biological Products, agreed that the condition is worth monitoring as the vaccine develops. He voted in favor of recommending the Pfizer vaccine last week.
“I still don’t rule it out,” he said in an interview with CNBC.
When Merck presented its data from its trial of the rotavirus vaccine, there were five cases of Kawasaki disease, but none from the placebo group. This was “statistically significant” and caused Merck to change its label to take the cases into account.
Although there was a small imbalance of cases in the vaccine group compared to placebo, the FDA said it is not certain whether the drug contributed to the paralysis “because the number of cases was small and not more common. than expected in the general population “.
“There were no other relevant patterns or numerical imbalances between treatment groups for specific categories of adverse events, including other neurological, neuroinflammatory, and thrombotic events, that suggested a causal relationship with the Modern COVID-19 vaccine,” the FDA personnel in the documents.
The FDA guidelines for the Moderna vaccine issued Tuesday were similar to the recommendations on the Pfizer vaccine last week. U.S. Centers for Disease Control and Prevention officials said the Pfizer vaccine does not appear to cause the disease.
– CNBC Berkeley Lovelace Jr. has contributed to this report.
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