Pfizer vaccine: UK regulator allays fears after 4 Bell's palsy cases in US trials
In trials conducted in the US, four out of 21,720 participants who received the Pfizer vaccine suffered Bell's palsy, but this is consistent with the trend in a random population
- Dec 9, 2020,
- Updated Dec 9, 2020 8:36 PM IST
UK drug regulator dismissed fears of Bell's palsy being associated with Pfizer-BioNTech COVID-19 vaccine after four participants of a US trials were afflicted with the medical complication. Bell's palsy is a temporary paralysis of facial muscles that leads to drooping of one side of the face.
The vaccine, codenamed BNT162b2, has been developed by US-based pharmaceutical company Pfizer and German biotechnology company BioNTech.
In trials conducted in the US, four out of 21,720 participants who received the Pfizer vaccine suffered Bell's palsy, as opposed to none out of the 21,728 subjects in placebo group. However, this is consistent with how common the viral reaction is in a random population - the UK observes 20-30 cases of Bell's palsy in 100,000 people per year.
Following the development, US Food and Drug Administration (USFDA) noted in its report that "four cases in the vaccine group do not represent a frequency above that expected in the general population."
UK drug regulator dismissed fears of Bell's palsy being associated with Pfizer-BioNTech COVID-19 vaccine after four participants of a US trials were afflicted with the medical complication. Bell's palsy is a temporary paralysis of facial muscles that leads to drooping of one side of the face.
The vaccine, codenamed BNT162b2, has been developed by US-based pharmaceutical company Pfizer and German biotechnology company BioNTech.
In trials conducted in the US, four out of 21,720 participants who received the Pfizer vaccine suffered Bell's palsy, as opposed to none out of the 21,728 subjects in placebo group. However, this is consistent with how common the viral reaction is in a random population - the UK observes 20-30 cases of Bell's palsy in 100,000 people per year.
Following the development, US Food and Drug Administration (USFDA) noted in its report that "four cases in the vaccine group do not represent a frequency above that expected in the general population."