U.S. Food and Drug Administration staff recommends monitoring people who get Pfizer or Moderna’s Covid-19 vaccine shots for possible cases of Bell’s palsy, saying it’s not necessarily a side effect but worth watching out for after a handful of trial participants got the condition, which causes half of your face to droop.
A 54-page staff report released Tuesday said there were four reported cases of Bell’s palsy among Moderna’s more than 30,000 clinical trial participants. Three of the participants who got Bell’s palsy also received the vaccine instead of a placebo shot. Pfizer’s trial similarly had four reported cases of Bell’s palsy out of some 43,000 participants. All four Bell’s palsy cases in Pfizer’s trial got the vaccine and not the placebo.
The staff, which endorsed the emergency use of Moderna’s coronavirus vaccine, said there wasn’t enough data to tie the cases directly to the shots, but it warranted close scrutiny.
Two of the cases of Bell’s palsy among Moderna’s vaccine group have since “resolved” while one was still ongoing at the time of the report, the FDA staff said. The vaccinated participants experienced the paralysis between 22 days and 32 days following inoculation, they said.