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by gns24 2004 days ago
I assume you are referring to the approval process. I've been thinking that too.

I don't want to be that person who thinks a really complicated thing should be trivial, so: Can anyone suggest why it would take weeks to approve these vaccines? What might the regulator actually be doing in this time?

They're clearly going to know that the request is urgent, and know when it's going to be arriving in their inbox; they could ask for anything apart from final data ahead of time to check everything is as they want it. I don't see why they can't have made sure they were happy with everything else ahead of receiving the final data.
2 comments
kenhwang 2004 days ago
Both Pfizer and Moderna were approved within a week of request. So it's not expected for the approval process to be slow.

If you compare the data between Pfizer[1] and AstraZeneca[2]. The AZ trials were significantly more complicated, with variations in methodology between phases and locale and much smaller sample sizes. It looks like they had to massage data and combine phases and explain differences, why they were doing it, and why it should still be considered safe.

Pfizer just submitted a giant sample size homogeneous trial result.

I would imagine it's way easier explaining and approving the one methodology/result with a giant sample size from Pfizer than the four methodologies/trials with small sample sizes and different doses within those trials given by mistake from AZ.

[1] https://www.nejm.org/doi/10.1056/NEJMoa2034577 [2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

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timurg 2004 days ago
in the findings for AZ, there is 1 reported death. So this means particapnt got the virus outside and vaccine didn't work right?
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kenhwang 2004 days ago
> From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death.

Means they didn't get the vaccine at all.

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timurg 2004 days ago
ahh ok all in the control arm
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robertlagrant 2004 days ago
Given the pace, and the lack of years-long trials, they perhaps brought in a lot of additional people to help analyse the methodology and data.
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