A number of Pfizer and Moderna COVID-19 vaccine trial participants got Bell's Palsy after they were given doses of the vaccines. Therefore, the United States Food and Drug Administration (FDA) advises overseeing people who get the shots for probable cases of Bell's Palsy, which is not necessarily a side effect but worth watching out for.
Bell's Palsy from Pfizer and Moderna COVID-19 Vaccine Shots
According to a 54-page staff report released on Tuesday, there were four reported cases of Bell's Palsy among Moderna's over 30,000 clinical trial recipients of its vaccine.
Inoculations are underway in the United States. However, after seven people received an injection -- four people in Pfizer-BioNTech's trial and three people in Moderna's trial, developed Bell's Palsy, a paralysis of the facial muscles, misinformation is becoming prevalent online.
While Bell's Palsy sounds alarming, the symptoms result in half of the face appearing to be drooping. It is more common than people think and often goes away within weeks to a few months, reported WREG.
Moderna's novel coronavirus vaccine appeared to be slated for regulatory authorization this week after the FDA's staff members did not dispute over the vaccine in documents released on Tuesday.
The FDA reviewers stated two doses of the regimen of Moderna's vaccine effectively alleviated coronavirus cases and did not identify safety issues with the vaccine's usage in adults beyond 18 years old, reported Humans Are Free.
Pfizer's clinical trial also had four reported cases of Bell's Palsy out of an estimated 43,000 participants. All four of Bell's Palsy cases in its trial were administered the vaccine and not the placebo.
The staff, which supported the emergency use of Moderna's COVID-19 vaccine, remarked there was inadequate data to associate the cases directly with the shots. However, it warranted scrutiny.
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Two of the cases of Bell's Palsy among Moderna's vaccine team have since been "resolved" while one was still underway during the time of the news.
The FDA, at this point, does not have adequate proof to associate the condition with the immunizations.
Although there were rare instances in which trial participants for the Pfizer and Moderna COVID-19 vaccines experienced the condition, the agency stated the rate it occurred in the trials is consistent with the general population's background rate.
The FDA typically follows the recommendation of the panel, although it is not required at all.
Moderna's is the second vaccine authorized by the agency, behind a vaccine from Pfizer and Germany's BioNTech, which was authorized the previous week.
The vaccinated participants of Moderna's vaccine remarked the paralysis occurred from 22 days to 32 days after vaccination.
Bell's Palsy also results in abrupt freezing or weakness in an individual's facial muscles that are temporary for most people.
The four cases in the Pfizer trials had Bell's Palsy at different times after the injection -- the first was three days after, the second nine days after, the third 37 days after, and the fourth 48 days later. At least one has made a recovery as of last week.
