[pip08456]

Originally Posted by jonbxx

This is why drug regulation is split up into strands. The first answers the question 'is the drug safe and effective'? This is the job of the MHRA, EMA, FDA, etc. The next questions is who can and can't have a drug, when and how? In most cases, the regulatory body such as the MHRA does this too. This is the Marketing Authorisation.

The third question is who are we going to give this to given the data of safety, effectiveness, side effects, costs, quality of life, etc. This is more a clinical decision. In the UK, NICE usually makes this decision though JCVI will in the case of vaccines.

My feeling is that the separation of these strands is important. With the safety and effectiveness being 'blind' and scientific and the clinical application being the more 'human' side.

Say for example, that the findings were that there was a slight increase in clotting issues. Then the Marketing Authorisation would be adjusted to state this and then the clinicians would take the risk/benefit decision. For example, if you have clotting issues, then the AZ vaccine is not the one for you.

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Just to add, investigating this was the right thing to do in my opinion. In vaccine sceptic groups, saying 'nah, it's fine' probably doesn't wash. Saying let's stop, have a look, check and act on the results is more likely to get past vaccine sceptics. Of course, it's not ideal as it slows down the roll out but one reports were out, it needed to be done

But the statiscs! It's always about statistics!!!!