And more detail (including a useful timeline on the Astra/Oxford vaccine) here:
hildabastian.net/index.php/100
Plus:
“Where does this leave us? I discuss issues and red flags in detail at WIRED, but a few major issues didn’t fit there. The press release doesn’t provide the most basic level of detail to enable us to understand what they did: we don’t know how the percentages were derived, exactly what the comparisons were, or what the level of uncertainty (confidence intervals) is around the numbers they reported. We don’t know if they had enough severe Covid-19 events to draw meaningful conclusions about that critical issue.
Given the enormous difference in when second injections were given – in the Brazilian trial it could be up to 3 months – we really need to see what happened to the people in that interval. The primary analyses for efficacy are done after the second injection – but to get an idea of likely effectiveness, we also need to know what happened in between shots, and how many people didn’t get that second shot at all. That’s important for any two-shot vaccine, but it’s particularly critical for one with a high rate of adverse events.
Bottom line? When you consider the press releases from BNT/Pfizer and Moderna alongside the detail they report in their protocols and for their very large coordinated trials generally, it’s easy to be confident those vaccines work very well – even though there’s still a lot to know.
With the Oxford/AstraZeneca vaccine, though, the combination of what we know about their trials, the twists and turns of their interim analysis process, and the contents of the press release, the case for having serious doubts about those results is strong. We certainly don’t want to throw babies out with the bath water. Just because the trials and data analyses are badly flawed, doesn’t mean that the vaccine is too. It just means that the US trial – including any new dosing regimen they want to test – has to be rigorous, and it’s indispensable. What’s just happened has the hallmarks of being “Plan B” after the big US trial they talked about in July took so long to get off the ground – only to be grounded for weeks because of safety review. But “Plan A” shouldn’t all that far off.
Meanwhile, the mRNA vaccines from BNT/Pfizer and Moderna are well down the road. Results for 3 inactivated virus vaccines are just around the corner: 1 from Sinovac, and 2 from Sinopharm. And it probably won’t be all that long till we start hearing more about Johnson & Johnson’s single shot vaccine.”