Thought this blog posted to Wired on the vaccine trial reporting was very good and worth a read. http://hildabastian.net/index.php/100
Basically, the two mRNA trials were well set out Phase 3 designs with one simple endpoint. Reporting of them in press releases (which is a mandated activity for any trial results material to the share price) was clear and straightforward, as is the interpretation. By contrast, the world-beating Oxford/AZ trial was more convoluted, an amalgam of multiple trials and objectives, and reporting was (ahem) less than transparent. Only after Warp Speed’s Moncef Slauoi revealed the randomisation has the true nature of the results come out.
Basically it appears that one contract manufacturer did not transfer the release assay for concentration of virus in the vials. This lower strength vaccine was used unwittingly and the reported reduction in adverse events led to further investigation.
In Biotech Land, the process is the product. If you can’t make it reliably then you are absolutely looking for the paddleshop. On a scale of 1 (minor trial issue) to 10 (failed trial) this would rate about an 8-9 maybe a 10. OK the remainder of the data is probably OK (60% efficacy is enough for an emergency license) but the 90% efficacy can be wholly disregarded. The fact that the data is confounded (no >55 received the low dose) and there are no US patients due to an FDA clinical hold during the trial means that the vaccine won’t be approved in the US without a further trial. AZ’s CEO admitted as much and they will run a further trial.
MHRA may approve the Pfizer/Biontech vaccine this week for emergency use, ahead of the EMA.
If you want some good news, we are presently at the peak of the second wave of deaths and things will continue to go down as we leave lockdown into lockdown lite.