FDA Suggests Watching COVID Vaccine Recipients for Bell's Palsy

The Food and Drug Administration on Tuesday recommended monitoring COVID-19 vaccine recipients for possible cases of Bell's palsy.

In determining Moderna's vaccine was safe and effective against COVID-19, the FDA added that four of more than 30,000 trial participants developed Bell's palsy. Three of those four received the Moderna vaccine and not a placebo.

"Currently available information is insufficient to determine a causal relationship with the vaccine,” the FDA staff wrote in a 54-page staff report released Tuesday per CNBC.

The Business Insider reported FDA's approval of the Moderna vaccine likely means it can be used for emergency use as early as next week. It would join Pfizer’s vaccine as being distributed across the US. 

Pfizer's vaccine, approved last week and distributed Monday, also showed possible links to Bell's palsy in its trials. Out of about 43,000 Pfizer trial participants, four people developed the ailment.

The FDA said Bell’s palsy isn’t necessarily a side effect but the situation should be monitored.

Bell's palsy is a form of temporary facial weakness or paralysis that causes the face to droop. It’s usually temporary. Steroids are considered highly effective at treating new cases of Bell's palsy.

The FDA said two of the Moderna cases of Bell’s palsy have been "resolved” while one was still ongoing at the time of the report. The vaccinated participants suffered facial paralysis between 22-32 days following inoculation.

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