This week, the U.S. Food and Drug Administration (FDA) released an analysis of the Pfizer-BioNTech vaccine, which included cases of facial paralysis in volunteers, ahead of a meeting to consider the U.S. emergency use vaccine mandate, sparking public concern.
The Washington Post reported on Dec. 8 that in the analysis report released by the FDA, it was mentioned that side effects were commonly seen in volunteers after injecting the Pfizer-BioNTech vaccine, but they lasted for a short period of time. Most showed symptoms such as soreness at the injection site, fatigue and headache. Four of the vaccinated volunteers developed Bell’s palsy (a temporary paralysis of the facial muscles, known as facial palsy), but the report also noted that there is no clear evidence linking the vaccine to the uncomfortable medical condition.
According to additional details reported by Russia Today on Dec. 9, four cases of facial palsy were found in the U.S. trial of 21,720 people who received the Pfizer vaccine, compared with none in the 21,728 people who received the placebo.
In response, the FDA said in its report that the four cases in the vaccine group did not occur more frequently than the overall expected number. While there was a “quantitative imbalance” in the two control groups, no other “non-serious adverse events” showed a similar pattern.
Nevertheless, the agency recommends “surveillance of Bell’s palsy cases through deployment of the vaccine to a larger population.
Aside from some side effects, the vaccine has generally received good reviews from the FDA. In its report, the agency said that the two-dose vaccine was still about 50 percent effective, even after only the first injection. The vaccine is believed to be 95 percent effective after a second dose three weeks later. The report also noted that the first dose of the vaccine reduced the risk of developing severe cases of neocrown pneumonia.
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