It's a remarkable f*ck up for a clinical trial. These decisions should have been made with data from gold standard analytical methods.
And of course the method itself is suspect, as the main benefit is that it is cheap and quick, not accurate. And then taking the wrongly performed measurement with the worse method over the qPCR by the manufacturer (who likely has much more robust QC than someone in academia) is just insane.
This is completely mysterious, in the opposite direction of every other vaccine candidate, and should we be following normal safeguards, there is zero chance this vaccine would be approved.
It also raises concerns of rushedness/negligence. When you get two conflicting measurements of the dosages, the correct response is to test it a third time, not assume the second is correct. This failure mechanism was the same in Boeing.
Not that we need to be: we already have Pfizer and Moderna, that did their trials properly and showed proper results.
They have already begun testing the half-full dose as another trial, so if that works better than full-full we may see the approval modified down the line.
> we already have Pfizer and Moderna
Unfortunately production constraints are going to mean that it will take a long time for those two vaccines to be produced in enough quantity to vaccinate most of the rich world. The cost for them and temperature requirements mean that they'd be impractical for most countries even in a few years.
We don't know that. As with the Pfizer and Moderna trials, the endpoint was incidence of disease, and only people with disease symptoms were tested. 60% fewer people experienced symptoms in the treatment group than the control group, but some of those may well still have "gotten it." There were very likely asymptomatic infected people in both groups, and we have no idea how many there were, or how the numbers different between groups. For all we know, just as many people in the treatment group were infected as in the control group, they were capable of spreading infection the whole time, and all the vaccine did was suppress their symptoms. (Again: possibly true of any of the vaccine candidates.)
[0]https://jamanetwork.com/journals/jamanetworkopen/fullarticle...
Edit: Nature mentions they did: https://www.nature.com/articles/d41586-020-03504-w
Which dosing regime should be recommended in this case?
https://www.nature.com/articles/d41586-020-03326-w
- Statistical effects, which might decrease the difference as the trial progresses. - A bigger dose causing an over-effective suppression of the carrier adenovirus, suppressing it's ability to make the COVID spike protein, and hence the production of COVID targetting T cells.
There is also a huge flaw in the testing of the Pfizer and Moderna vaccines: they didn't test everyone. Only people with symptoms (whatever that means) were tested (PCR). Whereas with the Oxford AZ vax all participants were tested, so we can actually get an idea of asymptomatic infection.
Wow, do you have a source for this? That's quite a stunning difference and really should put the ~~Pfizer~~ BioNTech and Moderna vaccines in doubt if the aim is herd immunity.
They seem to have preliminary results for asymptomatic testing: 14/14314 asymptomatic individuals were found in the vaccine group v/s 38/14073 in the control group. At least from the preliminary data, the Moderna vaccine nowhere near as effective in stopping asymptomatic infections.
https://theconversation.com/covid-19-vaccine-faq-6-things-to...
You'd have to look at the registered study details for the full protocol. See this BMJ article for references:
BMJ 2020;371:m4058 | doi: 10.1136/bmj.m4058
It doesn't prevent herd immunity if it only prevents the disease (i.e illness) but it makes it very difficult to achieve strong suppression if there is vaccine hesitancy (a polite grab bag term for science denialism, people who watch Fox, loopy muffin brain people, etc) above 20%. Which there will be in many parts of the US and Europe because of years of uncontested bullshit. (Thanks Facebook.)
I'm also pretty convinced if a "mishap" like that came to light about the Russian Sputnik, or one of the Chinese vaccines, then the combative and critical tone would go straight to "How Putin/Xi personally wanted to kill millions of people!" with news outlets all over the planet constantly regurgitating headlines along that line and Hanlon's Razor given zero consideration.
While this article ends on the notion of how this is just some kind of "oddity" and yet somehow at the same time allegedly a universal problem of "reporting having slightly nationalistic tone".
The article is so muddled up, and long-winded, the result of which is that it barely gains any traction in the online sphere, can't a find a single submission about this on Reddit with more than a dozen upvotes. The few there are the top-comments are very ad-hominemy "Good thing journalists never make mistakes!", which is a reminder that stuff like this [0] is a very real thing.