Pfizer Vaccine: UK Regulator Dismisses Bell’s Palsy Fears After Four Cases of Face Paralysis
Britain’s drug regulator today dismissed safety fears over the Pfizer and BioNTech coronavirus vaccine after a report revealed four people in a trial in the US got Bell’s palsy.
The condition, which is usually temporary, causes muscles on one side of the face to droop because of nerves not working properly.
Four cases of it were found in a group of 21,720 people who had the Pfizer vaccine in a trial in the US, compared to none among 21,728 people given a placebo vaccine.
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But this rate of occurrence is no different to how often it would be expected to happen in a random population – in the UK there are around 20 to 30 cases per 100,000 people per year.
The Food and Drug Administration in the US said in its report: ‘The four cases in the vaccine group do not represent a frequency above that expected in the general population.’
This means that it was almost certainly random that all the people who developed the condition happened to be in the vaccine group, and the same number of people would likely have got it in any group that size, regardless of a vaccine.
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And the British counterpart, the MHRA, said today: ‘The general safety profile of this vaccine is similar to other types of routinely used vaccine.
‘No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.’
The Pfizer/BioNTech vaccine, proven to be safe in clinical trials, is now being given to members of the public in Britain, which is the first country to give a jab to its citizens.
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Vaccines have to have their safety rigorously assessed before they can be approved for public use and, during this time, every health problem suffered by people who have had the jab is recorded.
This generally includes dozens or even hundreds of illnesses completely unrelated to the vaccine, as well as some that could be triggered by the jab.
The FDA said in its report of the Pfizer/BioNTech vaccine: ‘Among non-serious unsolicited adverse events, there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group, though the four cases in the vaccine group do not represent a frequency above that expected in the general population.
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SOURCE
Author: Sam Blanchard
Publication: Mail Online
Title: UK regulator dismisses Bell’s palsy fears over Pfizer vaccine after report reveals four cases of face paralysis in 22,000 people in the US – but the condition happens JUST as often in the general population
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