Pfizer Covid US trial - Bell's Palsy

[trulydelicious]

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

www.businesstoday.in/sectors/pharma/pfizer-vaccine-uk-regulator-allays-fears-after-4-bells-palsy-cases-in-us-trials/story/424382.html

Could anyone please advise on this? Are the regulators saying that if you take 20.000 random people, 4 of them are bound to develop Bell's palsy within a similar timeframe that the trials took place in the US? And that's why they are disregarding this issue for emergency approval?

Same here with appendicitis

The side effects were rare but inflammatory in nature. For example, there were more cases of appendicitis and Bell’s palsy among those who received the vaccine than in the placebo group

www.fiercepharma.com/pharma/pfizer-s-covid-vaccine-data-raise-some-questions-but-shouldn-t-scuttle-fda-nod-analysts

Please don't shoot the messager. I'm trying to understand

It's saying that the numbers who get it are consistent with the numbers who would get those two things anyway in the population, even without the vaccine. Nothing to be concerned about

My husband and I both have no appendix so it's not that uncommon !! This is honestly a non event!

Yes they would expect 4 out of 20,000 of the population to have that happen anyway. It is not connected to the vaccine in any way. With trials they have to be so careful but obviously people have illnesses every day without being in a trial. So not everything can be connected back. If for example 100 out of 20,000 got Bell's Palsy then there might be a link as that would be a higher rate than it occurring naturally in the general population.

@OpheliasCrayon

Yes, that's how I read it as well

It just seemed odd that both Bell's palsy and appendicitis occurred within the group given the vaccine and not in the placebo group (or it was lower in the placebo group in the case of appendicitis)

I’ve known lots of people randomly get Bells Palsy too. The scientists who do these studies aren’t out to lie to anyone, they will have done the maths to determine if the change is statistically significant to show a causation.