Results from a US trial of AstraZeneca’s Covid vaccine may have used “outdated information” on its efficacy, according to a US health agency. Reuters has the story.
The concerns throw into question whether the British drugmaker can seek US emergency use authorisation for the vaccine in the coming weeks as planned, and come just one day after interim data from the trial had shown better-than-expected results.
The vaccine developed with Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation and posed no increased risk of blood clots.
The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data”, the US National Institute of Allergy and Infectious Diseases (NIAID) said in a statement.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” it said, adding that the DSMB had informed AstraZeneca of its concerns.
The NIAID did not specify what outdated information AstraZeneca relied on from its trial. In Europe, the AZ Covid vaccine has been at the centre of fears relating to side effects from the jab, such as blood clots. This latest development in the US could, if found to be true, see the country refusing to grant emergency use authorisation as planned.
Worth reading in full.
Stop Press: AstraZeneca has responded to concerns over its vaccine from the DSMB, saying that the numbers it published yesterday were “pre-specified” and that more detailed information would be sent to US health officials within 48 hours.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
compressing 15 years of tests into 6 months is always going to lead to some cutting corners. for something as important as this its not good enough to rely on press releases and comment on partially seen datasets. All the trial information should be live and downloadable by anyone including competitors. Sunlight is the best disinfectant
Your point is the central one. Forget detailed argy-bargy about the data; as said, the concept of a rushed vaccine is nonsense in terms of risk for a virus like this.
I think the idea of developing a vaccine in 6 months and vaccinating the majority of the population with it (hyper-vulnerable fair enough) would have been considered insane in 2019. It’s only because of the media and govt induced panic about what is provably similar to hong kong or asian flu in terms of mortality that our standards have dropped so far.
It took 15 years for MenB vaccine to go through tests. Does anyone seriously suggest that should have been compressed to 6 months ‘because of all the lives we could have saved’?
Right – lift all restrictions – unless this is about something else?
Hi Steve.
Haven’t posted since the old comments section left, but it’s nice to see you’re still giving us the stats in a simple to read format. Cheers.
I actually prefer this site after the change 🙂 And too lazy to set up on reddit or where everyone else has gone. Pity the numbers of contributors are lower.
I just post on breaks between report writing – its therapeutic !
In practise, the site seems to have gained in terms of focus, with fewer comments simply becoming part of an extended repetitive whine.
Add to that picture the cumulative deaths from 2020 Week 1, and you have a year + of high-ish, but not exceptional mortality overall.
… and that will include a lot of deaths attributable to lockdown factors and other misattributions to Covid.
The government said that 1/3 of last march peak was from lockdown. After a year of it I suspect this winter peak is pretty much all from lockdown.
‘Died within 28 days of being in lockdown’
Sadlidied with longlockdown.
I like ‘longlockdown’ – I’ll use it today
and of course this
If you find some UN articles from ten years ago about predicted death rates they all have them going up from 2020 due to ageing demographics. That chart would look totally unsurprising to the statisticians in 2010 and they would be puzzled if we claimed it was a pandemic. The predictions have death rates continuing to rise, in fact here’s the current situation with UN predictions for the UK from macrotrends.net. What pandemic?
The smoothed curve of UK mortality for the last quarter century describes a partial sine-wave. The important aspect of this is that, after reaching a nadir in the last ten years, the mortality trend rate was increasing again before the dip in 2019 and the compensation in 2020.
I have problems with ‘age standardization’, as you may have clocked – it introduces modelling assumptions into the descriptive data. (This isn’t to deny that age structure has an effect). Ordinary population standardisation gives a less contaminated picture – and clarifies what a nonsense the country has been subjected to.
you are right. below is the crude death rate – its similar
AZ are continuing to make a right horlicks of this.
My wife had to visit our French doctor yesterday on a completely unrelated matter. As she was leaving he asked her, actually begged her would be a better description, to make an appointment for next saturday when he was going to inject the AZ vaccines he couldn’t get rid of. He confirmed that the French are not keen on any vaccine, but they just wont touch the AZ one. He joked that he was sure she would have it as it was ‘english’. She politely declined the offer.
Something made in India by a joint British/Swedish company headed by a Frenchman is ‘english’. You can sell a turd on a stick to some people, but not everyone.
If I was forced, I’d have the monkey one over the frankenstein one. But I think I’ll avoid them all as they haven’t been tested and I’m at more risk of being hit by lightning
Agreed. The only one we might even consider , but unlikely, is actually the conventional one under development in France by Sanofi and GSK, they are months away because they are actually testing on animals first!
I’m in a quandry – I won’t have anything that’s been tested on animals but I won’t have anything that’s not even been tested on animals
As you said if it was for something serious you might have a problem. For something with an IFR of 0.23% I think your problem is solved.
and far lower at my age/health – less than flu which I think the cross-over is about 60
They are months away because they ballsed up the initial study by using the wrong dose and are having to repeat it. Ph3 studies won’t complete until end of year earliest….assuming there is actually enough infection around to conduct a proper study. Which I am sceptical about.
But it is a more traditional recombinant antigen approach.
The other issue is that, with the current limited data, the ‘vaccines’ are prophylactic, not preventative (government actions indirectly confirm this).
So what is the advantage over what is more firmly known about the effectiveness and safety of Ivermectin as prophylaxis?
Well there lies a tale doesn’t it. Rapid and full use of ivermectin or HCQ/zinc and the illnesses and deaths would have been a fraction of the outcome. But nobody would have made any money!
Anything to keep peoples of the world locked up indefinitely.
For anyone still thinking that Tom Chivers (Unherd) has useful things to say, this (from his latest article) should give pause for thought. It begins :
“Seven million doses of a safe, life-saving vaccine are sitting in warehouses in the US….”
… and gets toe-curlingly, uncritically worse.
The more one thinks about the reality of SARS-CoV-2 as an endemic virus, the more it becomes obvious that the vaccination obsession is precisely the wrong strategy.
It is blindingly obvious that, for a virus like this, the effort should be going into research and development of the strong base of promising prophylactic treatment instead of wildly flailing around justifying the sunk costs of unseen virus purchase.
Nothing that’s happened since about last May has made any sense if you think about it from the point of view of protecting people’s health.
Or indeed any point of view. Unless your goal is to tank the economy and sell lots of useless masks.