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According to U.S. regulators, four people that received Pfizer’s Covid-19 vaccine in a trial developed Bell’s palsy which causes temporary facial paralysis.
The Food and Drug Administration (FDA) said Bell’s palsy could not have been caused by the vaccine but doctors should keep track of anyone else who gets it going forward.
This isn’t the first time it’s been linked to vaccines, but scientists have ultimately ruled that shots did not trigger Bell’s in all but one case – a Swiss flu vaccine that was sold during the 2001-2002 flu season there, then promptly taken off the market.
So far, the FDA said that the number of Bell’s palsy cases seen in the Pfizer vaccine trial 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,’ but will keep a close watch on future cases.
The four cases of Bell’s palsy were the only side effect that the FDA saw as ‘imbalanced’ with more occurring in the vaccine group than the placebo group, and fewer than 0.5 percent of the trial participants had serious side effects.
Among the four people who developed Bell’s palsy, one saw facial paralysis or weakness within three days after they received the shot. But the participant’s face returned to normal about three days after that.
Although doctors are not sure exactly what causes Bell’s palsy, there are some factors that can leave someone more prone to getting it such as diabetes or an upper respiratory infection like the cold or flu.
They don’t believe that Pfizer’s vaccine is the cause of the issue but if given the green light to move forward, the FDA says Pfizer will be required to track data on future vaccine recipients if they develop temporary facial paralysis.
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According to U.S. regulators, four people that received Pfizer’s Covid-19 vaccine in a trial developed Bell’s palsy which causes temporary facial paralysis.
The Food and Drug Administration (FDA) said Bell’s palsy could not have been caused by the vaccine but doctors should keep track of anyone else who gets it going forward.
This isn’t the first time it’s been linked to vaccines, but scientists have ultimately ruled that shots did not trigger Bell’s in all but one case – a Swiss flu vaccine that was sold during the 2001-2002 flu season there, then promptly taken off the market.
So far, the FDA said that the number of Bell’s palsy cases seen in the Pfizer vaccine trial 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,’ but will keep a close watch on future cases.
The four cases of Bell’s palsy were the only side effect that the FDA saw as ‘imbalanced’ with more occurring in the vaccine group than the placebo group, and fewer than 0.5 percent of the trial participants had serious side effects.
Among the four people who developed Bell’s palsy, one saw facial paralysis or weakness within three days after they received the shot. But the participant’s face returned to normal about three days after that.
Although doctors are not sure exactly what causes Bell’s palsy, there are some factors that can leave someone more prone to getting it such as diabetes or an upper respiratory infection like the cold or flu.
They don’t believe that Pfizer’s vaccine is the cause of the issue but if given the green light to move forward, the FDA says Pfizer will be required to track data on future vaccine recipients if they develop temporary facial paralysis.