With news breaking that Pfizer’s COVID-19 vaccine is going to start being administered as soon as this month, FDA reports are coming out about some concerning findings from clinical trials.
The staff did note “a numerical imbalance of four cases of Bell’s palsy” among people given the vaccine compared with no cases in the placebo group. The “four cases in the vaccine group do not represent a frequency above that expected in the general population,” the FDA staff said.
According to Health.com, a document released on December 8, ahead of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10, revealed more details about the Pfizer COVID-19 vaccine—which is expected to be the first to be authorized for emergency use in the US.
The document revealed that four cases of Bell’s palsy, a condition that causes temporary facial paralysis, were identified in study participants who received the vaccine—but in none of the participants who received a placebo. At least one of the patients has recovered, and there’s no evidence that the vaccine caused the problem.
What is Bell’s palsy?
According to the Mayo Clinic, Bell’s palsy, also known as acute peripheral facial palsy of unknown cause, can occur at any age. The exact cause is unknown. It’s believed to be the result of swelling and inflammation of the nerve that controls the muscles on one side of your face. Or it might be a reaction that occurs after a viral infection.
Although a chronic condition when active, it can be temporary for most people. Symptoms usually start to improve within a few weeks, with complete recovery in about six months. A small number of people continue to have some Bell’s palsy symptoms for life. Rarely, Bell’s palsy can recur.