Four people who received coronavirus vaccine in the company’s Pfizers study developed Bell’s palsy, a form of temporary facial paralysis, according to U.S. regulators’ report on the shot.
The Food and Drug Administration (FDA) regulators said it was not clear how the vaccine caused Bell’s palsy, but warned that doctors should be alert to the alarming side effects and Pfizer should continue to monitor how many people are affected.
Nobody knows exactly what causes Bell’s palsy, which clears up on its own most of the time.
This isn’t the first time it’s been linked to vaccines, but scientists have ultimately decided gunshots didn’t trigger Bell in all but one case – a Swiss flu vaccine sold there during the 2001-2002 flu season and then immediately the market was discontinued.
So far, the FDA has said that the number of Bell palsy cases observed in the Pfizer vaccine study was consistent with the background frequency of Bell palsy reported in the vaccine group, which is consistent with the expected background rate in the general population, and that it currently exists no clear basis for concluding a causal link. “We will, however, monitor future cases closely.
Four people who got the right shot in Pfizer’s study with the coronavirus vaccine developed a form of temporary facial paralysis known as the Bell Directive. New data from the company and FDA released ahead of Thursday’s regulatory approval meeting has been released. Pictured: a UK study participant receives the coronavirus vaccine from Pfizer