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US Food and Drug Administration employees recommend monitoring people receiving Pfizer or Modern Kovid-19 vaccine shots for possible cases of Bell’s paralysis, saying it may not necessarily have side effects, but a fist test Afterwards, the contestants get the position, which causes half of your face to fall.
A 54-page staff report released on Tuesday said there were four reported cases of Bell’s paralysis among Modern’s more than 30,000 clinical trial participants. Three participants who participated in Bell’s paralysis also received the vaccine instead of a placebo shot. Out of some 43,000 participants in Pfizer’s trial, Bell had four cases of paralysis. All four of Bell’s paralysis cases in Pfizer’s trial received the vaccine and not the placebo.
Staff, who supported Modern’s emergency use of the coronavirus vaccine, said there was not enough data to tie the cases to direct shots, but this warranted close scrutiny. FDA staff said that Bell’s two cases had been “resolved” among the modernism vaccine group, while one was still ongoing.
According to the Mayo Clinic, Bell’s palsy in a person’s facial muscles causes sudden cold or weakness. The Mayo Clinic said the exact cause is not known, but it is believed that it comes from viral infection or nerve inflammation and inflammation that controls the muscles on one side of your face.
“Currently available information is insufficient to determine a causal relationship with the vaccine,” FDA staff wrote.
FDA’s vaccines and the associated biological product advisory committee reviewed Modern’s vaccines on Thursday. It endorsed Pfizer’s vaccination a week before the FFA was given formal authority to begin distribution on Friday. Health care workers lined up at locations across the US to receive some of Pfizer’s first injections of the vaccine Monday.
A voting member of the FDA’s Vaccines and Related Biological Products Advisory Committee, Drs. Paul Offit agreed that the vaccine roll out was worth monitoring. He voted in favor of recommending Pfizer’s vaccine last week.
In an interview with CNBC, he said, “I’m not dismissing it.”
When Merck submitted its data from its rotavirus vaccine trial, there were five cases of Kawasaki disease but none in the placebo group. This was “statistically significant” and caused Merck to change its label to note cases.
Although there was a smaller imbalance of cases in the vaccine group compared to placebo, the FDA stated that it is not certain that the drug contributed to paralysis “because the number of cases was small and not higher than expected in the general population.”
“There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events, including other neurologic, neuro-inflammatory and thrombotic events, which would suggest a causal relationship to the modern COVID-19 vaccine,” “FDA staff wrote in documents.
The FDA’s guidance for Modern’s vaccine, released on Tuesday, was similar to its recommendations for Pfizer’s vaccine last week. The American Center for Disease Control and Prevention officials said that Pfizer’s vaccine does not cause the condition.
– of CNBC Berkeley Lovelace Junior. Contributed to this report.
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