Four Trial Volunteers for COVID-19 Vaccine Developed Bell’s Palsy, But FDA Denies

• Bell’s palsy is a form of temporary facial paralysis in which one side of the face to droop.
• The FDA noted that “four cases in the vaccine group do not represent a frequency above that expected in the general population.”
• UK drug regulators also dismissed fears about the incident in the U.S.

Four people who volunteered to get the trial shots of Pfizer’s coronavirus vaccine developed Bell’s palsy, according to a report from the U.S. Food and Drug Administration (FDA). However, the regulators stressed that it was not directly caused by the shot.

Bell’s palsy is a form of temporary facial paralysis in which one side of the face to droop. It happens when the nerve that controls that part of the face becomes compressed.

While the FDA denies a connection between the vaccine and the occurence of Bell’s Palsy among the four volunteers, the agency did warn that doctors should watch out for alarming side effects of the vaccine and that Pfizer should monitor these instances and note how many people are affected.

In its report, the FDA noted that “four cases in the vaccine group do not represent a frequency above that expected in the general population.”

The agency added that the number of Bell’s palsy cases seen in the Pfizer vaccine trial was “was consistent with the background frequency of reported Bell’s palsy in the vaccine group that is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time.”

This is not the first time that Bell’s palsy has been linked to vaccines. In most of these instances, scientists have been able to rule out a connection, except for a Swiss flu vaccine that was sold during the flu season in 2001-2002.

One of the four volunteers experienced weakness in the facial muscles or paralysis within three days after getting the shot. The volunteer’s face returned to normal after three days.

Another person experienced the symptoms nine days after the shot, while the others felt the paralysis 37 and 48 days after vaccination, respectively.

UK drug regulators also dismissed fears about the incident in the U.S. The FDA’s counterpart in the UK, the Medicines and Healthcare products Regulatory Agency, states that the safety profile of Pfizer-BioNTech vaccine is similar to other kinds of routinely used inoculations.