London: 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
UK drug regulator dismissed fears of Bell’s palsy being associated with Pfizer-BioNTech COVID-19 vaccine after four participants of 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 the 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.”
Its UK counterpart, Medicines and Healthcare products Regulatory Agency (MHRA) seconded the observation, stating that the safety profile of Pfizer-BioNTech vaccine is similar to other kinds of routinely used inoculations. No vaccine will be authorised for supply in the country without fulfilling the mandated standards for safety, quality and efficacy, the British healthcare regulator said.
The Pfizer-BioNTech vaccine has already received emergency use authorisation in the UK and Bahrain, the first jab to achieve this milestone. The companies are now trying to secure emergency use approval in other countries including India. The UK has begun to vaccinate its priority groups against COVID-19 using. Margaret Keenan, 90, and William Shakespeare, 81, were the first and second recipients of the jab vaccine in the world. The British government intends to administer 800,000 in the coming weeks.
-Courtesy by RT.com/USA
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