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After Admitting Mistake, AstraZeneca (Oxford) Faces Difficult Questions About Its Vaccine

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"The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90 percent effective was greeted with jubilation...

 

But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results."

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine - The New York Times (nytimes.com)

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Susco Platinum Member

Susco

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Who would have thought those pharmaceutical companies were lying through their teeth to get their stock prices up.

 

Until 2 weeks ago nobody had a vaccine, and then within a week they all have a vaccine, and not only that, but each one beats the other in efficacy of their vaccine.

 

Maybe soon we will have one that is 105% effective

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OneMoreFarang Star Member

OneMoreFarang

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Everybody was and is under huge pressure. Reduce that pressure! There will be a vaccine. And better an efficient and save vaccine in 6 or 12 months compared to a not well tested vaccine now.

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treetops Platinum Member

treetops

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It just reads to me like piece of fluff journalism from someone with an agenda.  Peer review will determine the future of the vacccine, not the opinion of a New York Times journalist.

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placeholder Star Member

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1 hour ago, Traubert said:

The New Yok Times..............

 

When will you all learn?

What specifically in the article do you find fault with? Or is it that you and the Chinese govt have never forgiven  the NYT for exposing how the children of China's governing class have enriched themselves? Or how that same governing class has it's own special food sources because of the dangers posed by the food available to most Chinese?

 

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mommysboy Ruby Member

mommysboy

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This is an argument about which dosing is best- nothing more than that. 

 

The company appears to have been up front about the dosing error.

 

I don't think either the company or the government ever claimed 90% efficacy.

 

 

 

Traubert Gold Member

Traubert

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49 minutes ago, placeholder said:

What specifically in the article do you find fault with? Or is it that you and the Chinese govt have never forgiven  the NYT for exposing how the children of China's governing class have enriched themselves? Or how that same governing class has it's own special food sources because of the dangers posed by the food available to most Chinese?

 

The way they stretch the truth.

 

No more, no less.

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Traubert Gold Member

Traubert

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2 minutes ago, placeholder said:

In other words nothing specific. You've got nothing.

What's non-specific about the above?

 

I.e. They stretch the truth. 

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carlyai Platinum Member

carlyai

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1 hour ago, placeholder said:

What specifically in the article do you find fault with? Or is it that you and the Chinese govt have never forgiven  the NYT for exposing how the children of China's governing class have enriched themselves? Or how that same governing class has it's own special food sources because of the dangers posed by the food available to most Chinese?

 

Oh come on.....doesn't sound like you have lived there (if you have I apologise). Admittedly we were only living there for 1 year, but the food we ate from the markets in the country was similar to the food we got from markets in Beijing on fortnightly visits.

Same as Thailand, rich and poor shop at the same markets.

I remember dad always put chook manure on the vegetable garden, (I ain't got 2 heads), now you can't do these dastardly criminal things because you will give everyone ecolii.

2530Ubon Gold Member

2530Ubon

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FAKE NEWS, with an agenda....

 

"The company’s initial announcement didn’t mention the accidental nature of the discovery."

 

As you can see below, the regulator was informed. The university and company didn't say it was accidental in the initial brief, but everyone was fully informed that some participants were given a half dose.

As the results were not altered and regulators were informed, scientific impartiality and the scientific data gathered is still valid - in fact more so...

 

“The reality is, it could end up being quite a useful mistake,” Mr. Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.”

 

How many scientific discoveries or 'eureka' moments have happened by accident? Let's name a few - x-rays, penicillin, LSD, microwaves

 

He added, “It actually doesn’t matter whether it was done on purpose or not.”

Edited by 2530Ubon
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GroveHillWanderer Platinum Member

GroveHillWanderer

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5 hours ago, Susco said:

Who would have thought those pharmaceutical companies were lying through their teeth to get their stock prices up.

The Pharmaceutical companies were not responsible for the efficacy figures. They come from an independent Data Safety Monitoring Board.

 

Also, there's no lying involved, and whether it came about by accident or by design makes no difference to the fact that a data analysis carried out by a totally independent monitoring body shows the serendipitous low dose-high dose regimen ended up producing scientifically-verifiable better results.

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Golden Triangle Platinum Member

Golden Triangle

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4 minutes ago, 2530Ubon said:

FAKE NEWS, with an agenda....

 

"The company’s initial announcement didn’t mention the accidental nature of the discovery."

 

As you can see below, the regulator was informed. The university and company didn't say it was accidental in the initial brief, but everyone was fully informed that some participants were given a half dose.

As the results were not altered and regulators were informed, scientific impartiality and the scientific data gathered is still valid - in fact more so...

 

“The reality is, it could end up being quite a useful mistake,” Mr. Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.”

 

How many scientific discoveries or 'eureka' moments have happened by accident? Let's name a few - x-rays, penicillin, LSD, microwaves

 

He added, “It actually doesn’t matter whether it was done on purpose or not.”

 

That's exactly how I read the initial announcement of this vaccine, apparently some people in the study only had a 75% protection from the smaller dose, this was noticed and with a further small dose they then achieved 90% protection, all this kerfuffle is a storm in a teacup.

treetops Platinum Member

treetops

Posted
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7 minutes ago, Golden Triangle said:

That's exactly how I read the initial announcement of this vaccine, apparently some people in the study only had a 75% protection from the smaller dose, this was noticed and with a further small dose they then achieved 90% protection, all this kerfuffle is a storm in a teacup.

It's the other way about, oddly enough.  The smaller initial dose gave the better results.

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Golden Triangle Platinum Member

Golden Triangle

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10 minutes ago, treetops said:

It's the other way about, oddly enough.  The smaller initial dose gave the better results.

Thanks for the clarification, I've slept since I first read it ????????

Traubert Gold Member

Traubert

Posted
Posted (edited)
2 hours ago, placeholder said:

Where in the article linked to was the truth "stretched"?

Somewhere between the beginning and end.

 

That's enough of your passive/aggressive bullying. Onto ignore with you.

Edited by Traubert
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Sheryl Star Member

Sheryl

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3 hours ago, mommysboy said:

This is an argument about which dosing is best- nothing more than that. 

 

The company appears to have been up front about the dosing error.

 

 

Basically yes but a bit more complex, because they had not intended to test 2 different dosing schedules and the trial was not set up for that.

 

What they need to do at this point is exclude  the cases that got the partial dose from the analysis and analyze the data for the planned dosage without those cases.

 

Then -- since it looks like the partial dose did work and might possibly be better than the planned dose -- do a separate trial designed to test that. With subjects of all ages.

 

It will delay things a bit but necessary.

 

 

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cormanr7 Advanced Member

cormanr7

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Time for a summary/evaluation of what little is known.

 

AstraZeneca was long seen as the frontrunner in bringing a vaccine to the market. However, they have been falling behind. IMO, they felt compelled to make an announcement after BioNTEch-Pfizer and Moderna published some results of large scale trials.

Apparently, AstraZeneca's data come from trials in the UK and Brazil and the following transpires:

 

1. Due to a 'manufacturing error', some participants received only a half dose for their first injection.

2. This was discovered when the half dose group showed less side effects.

3. There were 8,895 persons that received two full doses (let's call them Group A) and 2,741 (Group B) in the half then full dose group. All in Group B (and apparently most in Group A) were younger than 55.

4. Group A gave 62% efficacy and B 90%. These results were then pooled to give an 'average' efficacy of 70%.

5. There was no standardized placebo group protocol, with some receiving a meningococcal vaccin (UK) and others a saline solution (Brazil).

6. Larger trials are continuing but details are sketchy.

 

Some noteworthy points:

* the initially agreed trial set-up protocol was not followed

* in particular group B is very small and results may have been to chance or due to the fact that participants were <55. In fact it seems that people have been chosen which are most likely to show a good immune response.

* results from what are in fact two different trials have been pooled.

* side effects were probably more common/worse than claimed (see point 2).

 

AstraZeneca has not done anyone a favor by publishing these scientifically weak data.

 

 

 

 

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partington Gold Member

partington

Posted
Posted (edited)
2 hours ago, cormanr7 said:

Time for a summary/evaluation of what little is known.

 

AstraZeneca was long seen as the frontrunner in bringing a vaccine to the market. However, they have been falling behind. IMO, they felt compelled to make an announcement after BioNTEch-Pfizer and Moderna published some results of large scale trials.

Apparently, AstraZeneca's data come from trials in the UK and Brazil and the following transpires:

 

1. Due to a 'manufacturing error', some participants received only a half dose for their first injection.

2. This was discovered when the half dose group showed less side effects.

3. There were 8,895 persons that received two full doses (let's call them Group A) and 2,741 (Group B) in the half then full dose group. All in Group B (and apparently most in Group A) were younger than 55.

4. Group A gave 62% efficacy and B 90%. These results were then pooled to give an 'average' efficacy of 70%.

5. There was no standardized placebo group protocol, with some receiving a meningococcal vaccin (UK) and others a saline solution (Brazil).

6. Larger trials are continuing but details are sketchy.

 

Some noteworthy points:

* the initially agreed trial set-up protocol was not followed

* in particular group B is very small and results may have been to chance or due to the fact that participants were <55. In fact it seems that people have been chosen which are most likely to show a good immune response.

* results from what are in fact two different trials have been pooled.

* side effects were probably more common/worse than claimed (see point 2).

 

AstraZeneca has not done anyone a favor by publishing these scientifically weak data.

 

 

 

 

Unfortunately I agree with some of this.

 

[I'm not completely convinced that the best results came from a group that was all under 55, as the initial phaseII/III data about immunogenicity of the vaccine published in the Lancet recently listed results for two age groups older than 55.

 

 However it is not easy to check what ages were included in the actual trial whose efficacy was just reported.]

 

EDIT: just read on FT website  that AstraZeneca themselves say the group receiving the mistaken low first dose WERE indeed under 55, so please ignore above paragraph in parentheses[ ]. I'll leave it in to own up to my mistake!

 

I don't believe the group on which the 90% efficacy figure is based group was "chosen", it was simply the randomised group that accidentally received the faulty dosages. The group was in the  UK group not the Brazilian group.

 

Similarly I don't believe side effects were "worse or more common than has been claimed".

 

They were exactly as is being claimed. This how the investigators recognised that the incidence of side effects in the UK group that received the faulty dosage was lower than that they had previously documented and published.

 

However it certainly IS  unusual to be allowed to change the dosage specified in a trial protocol, whether by accident or design, and certainly the US protocol for trials of this vaccine (the only one published so far) specify no dosage changes are allowed. https://s3.amazonaws.com/ctr-med-7111/D8110C00001/52bec400-80f6-4c1b-8791-0483923d0867/c8070a4e-6a9d-46f9-8c32-cece903592b9/D8110C00001_CSP-v2.pdf

 

"6.6 Dose Modification

Study intervention will be administered as described in Section 6.1.2. Dose modification is not permitted."

 

When the error was discovered the investigators evidently immediately and correctly  disclosed it, and applied for permission to continue the trial. Perhaps because of the urgency of the COVID crisis they were allowed to do so. But this now becomes a combination of two trials with different protocols - very far from ideal. The different placebos in each arm are also worrying.

 

In addition, as has been pointed out, the study group that received the accidental low first dose is now way too small to have the statistical power for the results of efficacy to be reliable.  The 90%  efficacy figure must now be treated as extremely provisional indeed.

 

It does look very messy, and increasingly alarm bells are ringing.

Edited by partington

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