Quote:
Originally Posted by Sephiroth
If you look at the top part of the table and express >65 year cases as a linear proportion from the equation X = (29/5466)*341 then X is 1.8.
If there was nothing special about the >65 group, then the number of cases expected from 341 candidates would be 1.8. So, with the number given by AZ = 1, the only thing we can say is the sample size is insufficient to be meaningful.
I think everybody agrees on that. So, any decision to exclude the >65s from getting the vaccine is a simple matter of judgement by the relevant authorities. My instinct is that the >65s will benefit because the number was 1 not 2! A proper layman, am I.
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Yeah, you're right, the numbers don't look good but check out the confidence intervals (last column) All over the place! However, there's no technical reason to suspect that the vaccines won't work and/or are unsafe in over 65s.
The release for vaccines for use by either the MHRA in the UK or EMA in the EU are being done under different frameworks. The UK has given the vaccines we're having now an 'Emergency Use Authorisation' (EUA) This is not an approval of the vaccine in the traditional sense but more of a 'go ahead but you're on your own' status during the COVID emergency. One day, if COVID is gone, the authorisation will be withdrawn.
The EMA is working on a Conditional Marketing Authorisation (CMA) which is a step above an EUA in terms of the robustness of the data needed. CMAs can be converted to a full authorisation often quite easily. CMAs are time limited to 1 year.
I think it's due to the lack of data that the vaccine isn't being recommended for older recipients rather than any firm reason to doubt safety or efficacy.
Of course, the UK is currently generating a HUGE data set for over 65s right now which I am sure will be used to convert the various flavours of interim drug licencing into full licences