Source https://www.astrazeneca.com/content/ast ... icacy.html76% vaccine efficacy against symptomatic COVID-19
100% efficacy against severe or critical disease and hospitalisation
85% efficacy against symptomatic COVID-19 in participants aged 65 years and over
Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021.
These results have been presented to the independent Data Safety Monitoring Board. The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks.
This primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from the 32,449 trial participants, an additional 49 cases to the previously announced interim analysis. Participants were randomised on a 2:1 ratio between the vaccine and placebo group.
The primary endpoint, vaccine efficacy at preventing symptomatic COVID-19 was 76% (confidence interval (CI): 68% to 82%) occurring 15 days or more after receiving two doses given four weeks apart. In addition, results were comparable across age groups, with vaccine efficacy of 85% (CI: 58% to 95%) in adults 65 years and older. A key secondary endpoint, preventing severe or critical disease and hospitalisation, demonstrated 100% efficacy. There were eight cases of severe COVID-19 observed in the primary analysis with all of those cases in the placebo group.
AstraZeneca (Latest Trials)
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This is the home for all non-political Coronavirus (Covid-19) discussions on The Lemon Fool
This is the home for all non-political Coronavirus (Covid-19) discussions on The Lemon Fool
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
And the very latest from AstraZeneca (as promised) on 25/3/21:-
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
Further to my post above on the most recent astrazeneca trial results, here is a link to the BBC's thoughts on the matter
https://www.bbc.co.uk/news/world-us-canada-56521166
https://www.bbc.co.uk/news/world-us-canada-56521166
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
Do you have this but from a reputable news source?scotia wrote:Further to my post above on the most recent astrazeneca trial results, here is a link to the BBC's thoughts on the matter
https://www.bbc.co.uk/news/world-us-canada-56521166
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
If you don't like the above source, read the original - I provided the reference.absolutezero wrote:Do you have this but from a reputable news source?scotia wrote:Further to my post above on the most recent astrazeneca trial results, here is a link to the BBC's thoughts on the matter
https://www.bbc.co.uk/news/world-us-canada-56521166
And then you can give us your thoughts on the original
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
According to newsnight, AstraZeneca were specifically asked by the US regulator to make trial data available as soon as possible. Then they get slammed by peer reviewers for publishing incomplete data.
Its almost as if US big pharma is trying to rubbish them to keep the much cheaper AstraZeneca product out of the market. Who'd have thought it.
Gryff
Its almost as if US big pharma is trying to rubbish them to keep the much cheaper AstraZeneca product out of the market. Who'd have thought it.
Gryff
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- Lemon Half
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Re: AstraZeneca (Latest Trials)
Too late for me. Astra Zeneca at 10am this morning. If anything should happen to me I've asked my good lady to carry on posting on my behalf. Perhaps I may yet speak some sensegryffron wrote:According to newsnight, AstraZeneca were specifically asked by the US regulator to make trial data available as soon as possible. Then they get slammed by peer reviewers for publishing incomplete data.
Its almost as if US big pharma is trying to rubbish them to keep the much cheaper AstraZeneca product out of the market. Who'd have thought it.
Gryff
AiY
Arm beginning to ache
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
My daughter (early fifties) decided to have the AZN jab (despite her inherited thrombophilia) a couple of days ago. Felt totally wiped out by the time she got home, lay down and slept for 3 hours before she could get the supper, but was fine the next day. Long may it continue that way.
Hope you will soon feel better AiY.
Hope you will soon feel better AiY.
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- Lemon Half
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Re: AstraZeneca (Latest Trials)
Glad to hear you're daughter's side effects were short lived. We're getting there together.Bouleversee wrote:My daughter (early fifties) decided to have the AZN jab (despite her inherited thrombophilia) a couple of days ago. Felt totally wiped out by the time she got home, lay down and slept for 3 hours before she could get the supper, but was fine the next day. Long may it continue that way.
Hope you will soon feel better AiY.
AiY
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- Lemon Slice
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Re: AstraZeneca (Latest Trials)
My wife was the same. I had to almost drag her downstairs so she could prepare dinner.Bouleversee wrote:My daughter (early fifties) decided to have the AZN jab (despite her inherited thrombophilia) a couple of days ago. Felt totally wiped out by the time she got home, lay down and slept for 3 hours before she could get the supper
BoE
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- Lemon Half
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Re: AstraZeneca (Latest Trials)
Did you get her a chair for the kitchen? It's the least you could do.Bubblesofearth wrote:My wife was the same. I had to almost drag her downstairs so she could prepare dinner.Bouleversee wrote:My daughter (early fifties) decided to have the AZN jab (despite her inherited thrombophilia) a couple of days ago. Felt totally wiped out by the time she got home, lay down and slept for 3 hours before she could get the supper
Scott.
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
I hope you were joking, Bubbles.Bubblesofearth wrote:My wife was the same. I had to almost drag her downstairs so she could prepare dinner.Bouleversee wrote:My daughter (early fifties) decided to have the AZN jab (despite her inherited thrombophilia) a couple of days ago. Felt totally wiped out by the time she got home, lay down and slept for 3 hours before she could get the supper
BoE
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- Lemon Half
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Re: AstraZeneca (Latest Trials)
You can do better than that can't youSnorvey wrote:I struggled to get my missus to do the chores after her jab.
'What chores'? she gasped
To which I replied: 'Oh I'll have a pint of lager thanks'
AiY
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
It's even worse than that, they got slammed by their own advisory board!gryffron wrote:According to newsnight, AstraZeneca were specifically asked by the US regulator to make trial data available as soon as possible. Then they get slammed by peer reviewers for publishing incomplete data.
Its almost as if US big pharma is trying to rubbish them to keep the much cheaper AstraZeneca product out of the market. Who'd have thought it.
Gryff
I got another mini tutorial from a friend of mine yesterday on clinical trials yesterday, in particular on data safety and monitoring boards. As it happens she has just moved onto a project to write the DSMB charters for a couple of new trials after her current trials got slowed down due to lack of ICU beds and has written quite a few DSMB charters for other trials in the past.
This is not in reaction to your post but I see a few people seem to think the DSMB is part of or closely associated with the FDA. It isn't. A DSMB is actually recruited for a specific trial by the drug company running that trial, AZ in this case, and is specific to that trial. There are strict rules on the composition of a DSMB for a trial and steps to attempt to ensure the members' independence e.g. they have to declare shareholdings and they are not allowed to have worked for the company within a certain period of time prior to being appointed to the DSMB. A DSMB is not some big organisation, it is typically 7 or 8 people and must include at least one statistician and one medic with expertise in the therapeutic area under investigation. Another possibly biased observation (from my friend) is that they tend to be academics so sometimes ask some "pretty stupid questions". Is that comment born of the arrogance of a clinical scientist with decades of industry experience or is it indicative of the "ivory tower" attitude of some academics who can be somewhat divorced from practical realities? I have no way to judge that.
The key fact though is that the primary communications interface is supposed to be with the company. During the running of the trial the people on the DSMB actually have the best visibility of anyone in the world of the trial data, better than the drug company itself, because they are the only people who get to see all the data unblinded from the outset so that they can raise an alarm privately to the clinical trials team at the drug company if they see something in the data that makes them think that the drug is giving worrying safety signals (or even too many side effects in the placebo possibly indicating a contaminated manufacturing batch of whatever is being used for the placebo). The drug company would then be expected to react appropriately of course.
This is what makes this episode all the more strange. These conversations that we're seeing played out in public really should have been happening in private between AZ and the DSMB and if those discussions had been going on in private between the DSMB and AZ in the few days or weeks before the DSMB made its public announcement was AZ saying the same thing, i.e. that the interim results were fulfilling a commitment and that the later data would be integrated and released only days later? If yes then why on earth did the DSMB feel it appropriate to blow a whistle in public when it dic? It seems similar to some Lemon Fool owing me £100 where in private PM discussions he/she has agreed to pay me back £50 today and the remaining £50 on Friday yet, as soon as I am paid the first £50 instalment today, I make a post on this board about that Fool not repaying his/her debts because I have only been paid £50 of the £100 I am owed.
I've seen a few people post theories that the DSMB might have been compromised in some way by other pharma companies or simply parochial "US vaccines are best" politics and I suppose that could well be the case. Alternatively maybe the grubby and disappointing truth is that this is all simply because of some really serious personality clashes between one or more people on the DSMB and one or more people in AZ causing this DSMB to behave so aggressively.
- Julian
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- Lemon Slice
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Re: AstraZeneca (Latest Trials)
Why is that worse? It's just another instance of Halon's Razor. No reason for questions in the House or a recall of the Ambassador.Julian wrote:It's even worse than that, they got slammed by their own advisory board!gryffron wrote: Its almost as if US big pharma is trying to rubbish them to keep the much cheaper AstraZeneca product out of the market. Who'd have thought it.
Gryff
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- The full Lemon
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Re: AstraZeneca (Latest Trials)
I bet AstraZeneca must wonder why they bothered to get involved in this whole thing, especially at no profit.
Dod
Dod
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- Lemon Half
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Re: AstraZeneca (Latest Trials)
Radio 4 did a profile of the AZ head honcho.Dod101 wrote:I bet AstraZeneca must wonder why they bothered to get involved in this whole thing, especially at no profit.
Dod
Apparently there's a grapevine. He's an old friend of a very senior Oxford prof, who contributed to the programme. So when Oxford saw their way to a vaccine but needed a big pharma partner to bring it from the lab to the market, they did the deal over a working lunch or somesuch.
Edit to add: https://www.bbc.co.uk/programmes/m000tg7d
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- The full Lemon
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Re: AstraZeneca (Latest Trials)
In the very recently published book (which I have commented on on the Books Board) The Code Breaker, the author tells us that the scientists at Oxford were already, in early 2020, genetically engineering a safe virus-an adenovirus that causes flu in chimpanzees- by editing into it the gene to make the spike protein of the coronavirus. The Bill and Melinda Gates Foundation provided early funding and Bill also pushed Oxford to team up with a major company that would manufacture and distribute the vaccine if it worked. Hence the partnership with AstraZeneca.
Of course, how AstraZeneca got involved is another story. UE's comments are perfectly possible, but I cannot help thinking (as a shareholder I may add) that Astra must now be wondering why they decided to do the work pro bono.
Dod
Of course, how AstraZeneca got involved is another story. UE's comments are perfectly possible, but I cannot help thinking (as a shareholder I may add) that Astra must now be wondering why they decided to do the work pro bono.
Dod
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- Lemon Half
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Re: AstraZeneca (Latest Trials)
"A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination"
https://www.researchsquare.com/article/rs-362354/v1
And read the declarations of interest....This research sponsored by (all pharma minus AZN).
https://www.researchsquare.com/article/rs-362354/v1
And read the declarations of interest....This research sponsored by (all pharma minus AZN).
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
I am totally confused. Germany has had about a 12% roll out with a large percentage Pfizer (sorry don't know the actual percentages). Are they basing their latest decision on their limited AZ national data or data from elsewhere ie data from extensive analysis in say Scotland?The German government yesterday suspended use of the AZ jab for under-60s after more apparent concerns over blood clots.
But how many non frontline people under 60 (anywhere) have been given AZ? Surely just 'at risk' people. Thus as far as I can see, only frontline staff and 'vulnerables' can actually make up this cohort. Any possibility of 'links' between these groups and blood clots (above the expected average in the overall population)?
I have a professional grounding in statistical analysis and yet am somewhat confused as to the robustness of statistical conclusions being drawn.
T7
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- Lemon Quarter
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Re: AstraZeneca (Latest Trials)
Thanks. That's an interesting article. I'm not 100% convinced by your conclusion re declarations of interest though, e.g. (my bolding) ...monabri wrote:"A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination"
https://www.researchsquare.com/article/rs-362354/v1
And read the declarations of interest....This research sponsored by (all pharma minus AZN).
Does the fact that the grant from Deutsche Forschungsgemeinschaft is qualified as "during the conduct of the study" imply that the other personal fees weren't and if not then how long in the past are the declarations covering? Could some of that stuff be stuff like investigator fees from a decade or more ago? Certainly if you looked at a declaration of fees received by my friends in the industry they would be declaring loads of stuff across multiple pharma companies which wouldn't imply being in those other companies' pockets, simply evidence of multi-decade careers in research and a mixture of consulting and full time employment within the pharma industry.Dr. Thiele reports grants from Deutsche Forschungsgemeinschaft, during the conduct of the study; personal fees and other from Bristol Myers Squibb, personal fees and other from Pfizer, personal fees from Bayer, personal fees and other from Chugai Pharma, other from Novo Nordisk, personal fees from Novartis, other from Daichii Sankyo, outside the submitted work.
I do agree it would be much more reassuring to see at least one co-author declaring some fees received at some point in their career from AZ and the total absence of that might be sinister but in terms of keeping an open mind I'm not willing to immediately jump to the conclusion that it is. It could simply be that this group of researchers were the right people with the right set of skills in the right place at the right time who had pre-established relationships and decided to work together on this.
When all of this first broke and there was much discussion about how many clots per million would be expected in the general population anyway I was totally perplexed as to why, if that was the case, the Pfizer and Moderna vaccines weren't also raising alarm bells due to clotting incidents. If it is specifically this very unusual type of clotting that is of concern then perhaps that clears up my initial confusion but I do wish that some regulatory authority, or even some investigative journalist although they would have far less authority but perhaps could shame companies into releasing information, could get data out of the other manufacturers regarding incidents very specifically of this rare clotting disorder amongst their vaccinated populations and make those figures public. I'd also like to know the incidence specifically of this rare condition that is to be expected in the general population. Just how rare is it? Maybe all that data is already published in which case I would applaud very loudly any journalist who pulled that data together and presented it clearly.
In the absence of data such as the above, i.e. the ability to compare the rate in the AZ vaccinated population with the rate in the general population and in the Pfizer and Moderna vaccinated populations, I feel totally unable to make any sort of personal judgement about whether there might be something to see here or not.
- Julian