AstraZeneca Downgrades Its Efficacy Claims Following Criticism From US Health Agency
AstraZeneca has downgraded its estimates of the efficacy of its Covid vaccine by 3% following recent criticism from a US health agency that results from a trial used “outdated information”. The pharmaceutical company hopes that this small revision will enable its vaccine to receive US approval in the coming weeks. The Mail has the story.
AstraZeneca today claimed its Covid vaccine blocked 76% of symptomatic infections in a major US trial, after downgrading its estimate slightly in the face of unprecedented public criticism.
The Anglo-Swedish pharmaceutical giant was accused of cherry-picking data by US watchdogs, who were “concerned” that the firm provided an “incomplete view” of the jab’s efficacy by releasing early results of the study.
But the recalculated figure was only marginally lower than the original 79% it bragged about on Monday. The data was based on the final results of the exact same 32,000-person trial.
AstraZeneca’s Mene Pangalos, Executive Vice President of Biopharmaceutical Research and Development, said the results were “consistent” with the interim results that sparked controversy.
He added the data “confirms our Covid vaccine is highly effective in adults, including those aged 65 years and over”.
The US National Institute of Allergy and Infectious Diseases (NIAID) expressed concerns over the use of “outdated information” in trial results in a statement earlier this week. The Mail reported:
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Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data”, the US NIAID said in a statement.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.
AZ scientists have commented that this statement was highly “unusual” given that such discussions are usually held behind closed doors, but have also expressed hope about the vaccine receiving US approval in due course.
The small revision to the efficacy rate will go a long way to putting the vaccine back on track for US approval, with the firm hoping it will be given the green light in the coming weeks. Britain’s regulators gave it the sign off in December.
The Mail’s report on this downgrading is worth reading in full.
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And AstraZeneca, just like the rest of the pharmaceutical industry, uses relative risk reduction rather than absolute risk reduction, which makes the efficacy claims completely misleading to the point of mendacity. Indeed, to be transparent, efficacy claims ought to be presented in actual numbers, frequencies.
Of course, hardly anyone would find the so called vaccines worth taking if the information was presented in such a manner.
The crucial issue, Steve.
Ask yourself which metric relating to a vaccine is the most rarely quoted, and you immediately have an immediate assessment of its worth. If it’s absolute risk that is the omission – it’s probably snake oil.
Would be interesting to have some accurate comparisons with the free, adaptable item that is pre-installed in almost every human and has developed over millions of years – our immune system. If defined as preventing death and hospitalisation, I’m pretty sure it does better than AstraZeneca’s effort.
For the children whose immune system is under development, the injection of these gene therapies is criminal. They will be impaired for life, there is absolutely no knowing what harm they can do. Its akin to the Nazi experimentations, that is not an exageration.
many things that would have been regarded as insane in 2019 are regarded by many as reasonable now
I still hold to 2019 ways of thinking (including the original pandemic response plan)
Its tantamount to child abuse. Any parent allowing their child to be injected for something that doesn’t affect them doesn’t deserve to have them!
Little by little the truth emerges. Maybe we should lobby to have the term ‘anti-vaxxer’ (which is not true of most of us) listed as hate speech.
This and conspiracy theorist are increasingly being used as acceptable forms of attack, usually when someone has a weak argument. I’m too thick skinned to be bothered, but it’s fear of this label that is silencing well qualified opinions.
With Finland and Denmark yesterday only approving for the over 65’s and Sweden and Norway to make a decision, it’s way beyond time that the risks are discussed in the British media.
no ‘excess mortality’ anywhere in europe
https://euromomo.eu/graphs-and-maps/
I wonder if its the lockdowns, vaccine, masks or track and trace?
can’t be any of those because of Sweden
update on Zoe hayfever tracker
R shown below
the peak and drop in mid feb was counting vaccine side effects as covid and then removing them
the slight rise from mid March is the start of the tree pollen season (which affects 25% of people) being misattributed to covid
How about more cats being out & about as Spring comes along resulting in more people like me being exposed to cat induced allergic reactions being put down to the Covid?
Gissa job, making it up as I go along.
I hadn’t thought of the cats! 🙂
With such low prevalence its all bloody nonsense is what I’m getting at
new PHE daily all cause mortality just out
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/973174/Weekly_Flu_and_COVID-19_report_w12.pdf
3%? Haha. Just get on and approve it. We don’t need this theatre and pretence of moderation. Regulators just trying to look like they are regulating.
Bookies wouldn’t even take a bet on any vaccine not being approved.
The Danish paper critiqued by Mike Hearn the other day claimed that previous infection with SARS-Cov-2 gave 80.5% protection against re-infection where reinfection was defined a having a positive PCR test. AZ claims 76% protection, where reinfection is defined as having symptoms. It’s a good job we waited patiently for the vaccine, rather than rushing into a herd immunity strategy like those irresponsible GBD “scientists” were advocating.
“previous infection with SARS-Cov-2 gave 80.5% protection against re-infection where reinfection was defined a having a positive PCR test.”
that’s got to be 100% protection when the FPs are removed
While I agree that false positives have played a significant role in some aspects of the way cases have been identified in this crisis, I’m not satisfied that they have much effect on this Danish study. I outlined my reasons in a comment on Mike Hearn’s piece earlier in the week. I suspect the true protection as measured in the trial is greater than 80.5%, but not that much greater. I suggest a better response is to consider what (re)infection actually means in practice. In the Danish study of natural immunity, infection is defined as a positive PCR test, with everyone in the study tested at least twice. In the vaccine trials, infection was defined as symptomatic (or positive PCR test but only following symptoms). What would the protection granted by natural immunity look like if the vaccine trial standard had been applied, or vice-versa? It would also be interesting to know what reinfection actually looks like. If someone has effective immunity, whether from prior infection or by vaccine, what is observed? Do they show symptoms but milder? Are they infectious? Does a PCR test still identify virus fragments? What about lateral flow? I’m not aware that any such work… Read more »
interesting. I wonder about testing positive after an initial infection – isn’t this just shedding old virus? a test by PCR of a second infection doesn’t sound very solid to me
Clare Craig had an interesting piece in the Autumn, probably linked on the right, in which she discussed not just false positives (papaya, tap water, lab error etc) , but also “cold” positives (old fragments remaining well after recovery, fragments of other viruses/lifeforms)
interesting misattribution
Hungary has stormed ahead of the UK in the death league
https://www.worldometers.info/coronavirus/
deaths heading up to a huge second spike
https://www.worldometers.info/coronavirus/country/hungary/
but zero actual deaths
https://euromomo.eu/graphs-and-maps/
all just normal expected deaths of old age being misattributed as ‘from’ covid
Another country showing a surge as it starts its vaccine rollout, and on the most vulnerable groups. If only they’d got those vaccines a few vital weeks earlier…
I’m not convinced there’s a correlation yet (there’s several different vaccines for starters), but my eyebrows are heading ever further north. Even Israel’s successful program was not without a little bump around the same time. If the connection is causal, it would suggest the vaccines are less safe for the older and vulnerable which is what you’d expect, but the opposite of the policy that Norway etc are now implementing. Then again, if the vaccines don’t prevent transmission…. then you can’t give them to the people you need to protect, and there’s no point giving them to the people you don’t need to protect.
Hopefully the people in charge know what they’re doing.
My own immune system gives me 99% protection, I’ll stick with that!
As Steve Hayes points out – let’s stop piddling about with irrelevant stuff about the quick buck ‘vaccines’, and simply repeat the key question :
“What’s the ABSOLUTE risk reduction?”
Then people can make up their own minds based on the key metric – and get on with life.
I remember Tim Spector saying in November that the problem with the vaccines coming is that the government would be tempted to lockdown until they have vaccinated everybody. It looks like that’s the plan. So if I refuse one then it speeds up the time until everyone has been offered.
And furthermore: https://theintercept.com/2021/03/18/covid-vaccine-price-pfizer-moderna/
…like Jake said back in Chinatown, “Follow the money”.
AstraZeneca are supposedly supplying covid vaccine at cost. Why do they bother with the difficult places: EU, USA, etc. Just don’t apply for licence in those places. The rest of the world probably wants it without all the political hassle.