AstraZeneca

dabhand · March 23, 2021

1 hour ago, lopburi3 said:

https://theweek.com/speedreads/973471/health-officials-say-astrazeneca-may-have-skewed-vaccine-efficacy-data-outdated-information

Above being reported by major sources within last few hours.

Yup, also being reported in the Guardian.

https://www.theguardian.com/business/2021/mar/23/us-health-agency-astrazeneca-covid-vaccine-trial-data

Presumably this has no connection with this recent article about US pharma plans to increase the prices of their covid vaccines.

https://theintercept.com/2021/03/18/covid-vaccine-price-pfizer-moderna/

mommysboy · March 23, 2021

It looks like a 'row back', with Fauci getting involved to defuse the situation

It appears Astrazeneca was instructed to publish a particular snapshot by one agency , which it did from Feb 23rd. That seems to have prompted another agency to assume that it was cherry picking its data.

The attack has been described as 'unprecedented'.

Make of it what you will.

AZ reminds me of the kid who turns up at school with a fat lip, and before you know it everyone's taking a pop.

rabas · March 23, 2021

Here is a full discussion about AstraZenica's latest data issues from ARS Technica's health expert.

Authorities raise red flags about AstraZeneca’s vaccine press release

mommysboy · March 24, 2021

1 hour ago, rabas said:

Here is a full discussion about AstraZenica's latest data issues from ARS Technica's health expert.

Authorities raise red flags about AstraZeneca’s vaccine press release

Quite simply they were told to publish that data.

The study is what 30000 people ?- it's been in 16 million arms in the UK, and the hard real world data shows great effectiveness- around the same as Pfizer. Do we ignore the real world then?

Personally, I don't doubt that efficacy is not 79% on a 4 week dosing strategy in a much more challenging study population, but then again it's on a sub optimal dosing regime- delaying the second dose increases efficacy to around the trial figure though.

I doubt any of the top vaccines would score more than 75% had they had a British trial, with the strict testing procedure used in the British AZ trial.

lopburi3 · March 24, 2021

The problem seems to have been a rush to publish and in doing so they used data that had not been properly reviewed or up to date. And they are now in defensive positions. Bad for everyone as more people will become hesitant to use or believe.

mommysboy · March 24, 2021

1 hour ago, lopburi3 said:

The problem seems to have been a rush to publish and in doing so they used data that had not been properly reviewed or up to date. And they are now in defensive positions. Bad for everyone as more people will become hesitant to use or believe.

It said: "The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of February 17."

The company added it had "reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis".

"We are now completing the validation of the statistical analysis," it continued.

There is no controversy other than that which people wish to make, really. It's a small issue anyway.

"Note that today one of the leading vaccines has had to withdraw a batch due to safety concerns over packaging. If that was AZ it would be blown out of all proportion and be taken as an opportunity to endlessly regurgitate all problems real or imaginary. As it is not the AZ vaccine, it will quite rightly get a few lines and be forgotten tomorrow)

lopburi3 · March 25, 2021

And today:

Quote

The company now says its vaccine is 76% effective in protecting against symptomatic cases of virus. A release issued on Monday reported a symptomatic efficacy rate of 79%.

https://www.cnbc.com/2021/03/24/covid-vaccine-astrazeneca-issues-updated-phase-3-trial-data.html

Only a marginal difference and still rates as one of the best - but a needless loss in the mindset of those needing vaccine who may have second thoughts not only on A-Z but on all.

Pib · March 25, 2021

The AstraZeneca company just keeps stepping into it. They have revised the efficacy rate form 79% to 76% after being challenged on the accuracy of their data. And the Italian govt found 29 million dozes in a AstraZeneca Italian facility which apparently had not been reported to the EU. It just makes any data the AstraZeneca company reports as questionable.....probably deserves a closer look.

https://thehill.com/policy/healthcare/544839-astrazeneca-updates-vaccine-efficacy-to-76-percent

Quote

AstraZeneca updated its vaccine efficacy to 76 percent after it said earlier in the week the efficacy was at 79 percent.

The analysis of 76 percent efficacy comes as the vaccine is in phase three for its U.S. trials to receive emergency authorization.

After AstraZeneca reported on Monday that the efficacy was at 79 percent, federal officials said the company used outdated data in its determination.

AstraZeneca admitted they used “pre-specified interim analysis with a data cut-off" from Feb. 17 in its calculation of 79 percent efficacy.

"We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis," the company said on Tuesday. "We are now completing the validation of the statistical analysis."

https://thehill.com/policy/healthcare/544783-authorities-find-29-million-doses-of-astrazeneca-vaccine-in-italian?utm_source=thehill&utm_medium=widgets&utm_campaign=es_recommended_content

Quote

Authorities discovered 29 million doses of the AstraZeneca COVID-19 vaccine in a facility in Italy on Wednesday, prompting some further tension between the European Union and the company amid the bloc’s attempts to restrict vaccine exports.

EU officials told The New York Times that Italian authorities uncovered the stash of doses during a visit to a site near Rome that is being used to produce AstraZeneca vaccines for the 27-nation bloc. The Italian daily La Stampa first reported on the stockpile.

Italy's Prime Minister Mario Draghi said some of the batches, which can have 1 million doses each, were taken and two batches were sent to Belgium, Reuters reported.

The European Commission had informed the Italian authorities that there was an inconsistency in data between the number of doses AstraZeneca said it was developing in the EU and the amount that the production facilities were reporting.

Crossy · March 25, 2021

20 minutes ago, Pib said:

The AstraZeneca company just keeps stepping into it.

The linked NY Times article does state:-

Quote

Four days of checks later, Italian officials accepted AstraZeneca’s explanation that the doses were going through quality control before being shipped to the developing world, and to European countries.

I assume this echoes the Italian La Stampa outlet (which is behind a paywall).

We shall see where these doses actually end up (possibly).

VocalNeal · March 25, 2021

What are the efficacy rates for legacy vaccination or inoculations against other diseases that we may have had as children?

Just for comparison?

We happily accepted those, or our parents did. Anyone working, or worked, in Africa for instance will have had jabs for tropical diseases. No one asked about efficacy rates or worried about the manufacturer or origins of the phial.

Are the efficacy rates for covid peer revued

lopburi3 · March 25, 2021

4 minutes ago, VocalNeal said:

What are the efficacy rates for legacy vaccination or inoculations against other diseases that we may have had as children?

Just for comparison?

We happily accepted those, or our parents did. Anyone working, or worked, in Africa for instance will have had jabs for tropical diseases. No one asked about efficacy rates or worried about the manufacturer or origins of the phial.

Are the efficacy rates for covid peer revued

The question being asked is honesty - nobody is saying this is bad or worse than any other pharma company - they all favor favorable information and often try to ignore anything else. Believe we have been very fortunate in this pandemic to have so many vaccines that all appear to be not only acceptable but good. But when companies are caught out making poorly supported boosts the public can lose faith and results could be very bad.

mommysboy · March 25, 2021

40 minutes ago, lopburi3 said:

The question being asked is honesty - nobody is saying this is bad or worse than any other pharma company - they all favor favorable information and often try to ignore anything else. Believe we have been very fortunate in this pandemic to have so many vaccines that all appear to be not only acceptable but good. But when companies are caught out making poorly supported boosts the public can lose faith and results could be very bad.

But it wasn't. This was a pre-specified interim result as far as can be seen. It's between Astrazeneca and the regulator. What this other obscure agency did was bizarre.

mommysboy · March 25, 2021

https://www.astrazeneca.com/media-centre/press-releases/2021/azd1222-us-phase-iii-primary-analysis-confirms-safety-and-efficacy.html

AZ has now updated the trial results as stated previously.

76% efficacy overall

85% efficacy for over 65's

100% against hospitalization and severe disease.

We await the next controversy (storm in a teacup) I guess.

mommysboy · March 25, 2021

3 hours ago, lopburi3 said:

And today:

https://www.cnbc.com/2021/03/24/covid-vaccine-astrazeneca-issues-updated-phase-3-trial-data.html

Only a marginal difference and still rates as one of the best - but a needless loss in the mindset of those needing vaccine who may have second thoughts not only on A-Z but on all.

Only with people who wish to make a mountain out of a mole-hill.

The efficacy has actually been revised up on over 65's, which is the most important age group. So, should we accuse them of deliberately understating too!

rabas · March 25, 2021

4 hours ago, mommysboy said:

But it wasn't. This was a pre-specified interim result as far as can be seen. It's between Astrazeneca and the regulator. What this other obscure agency did was bizarre.

No. The independent regulators have no authority other than that vested in them by US agencies like the NIH responsible for evaluating the vaccines. They do not report to AZ nor to the trial. They report to the US government and the NIH, neither of which is obscure.

In this case, 11 independent regulators responsible for evaluating the data saw need to write a letter to express their concern about that data.

"The letter came from 11 leading statisticians, infectious-disease physicians and ethics experts appointed by the National Institutes of Health to review trial data for all the major coronavirus vaccines supported by the federal government. It says the company’s decision to use early data that puts the vaccine in the most favorable light is a scientific misstep that could erode trust in the shot."

https://www.washingtonpost.com/world/astrazeneca-oxford-vaccine-concerns/2021/03/23/2f931d34-8bc3-11eb-a33e-da28941cb9ac_story.html

mommysboy · March 25, 2021

8 hours ago, rabas said:

No. The independent regulators have no authority other than that vested in them by US agencies like the NIH responsible for evaluating the vaccines. They do not report to AZ nor to the trial. They report to the US government and the NIH, neither of which is obscure.

In this case, 11 independent regulators responsible for evaluating the data saw need to write a letter to express their concern about that data.

"The letter came from 11 leading statisticians, infectious-disease physicians and ethics experts appointed by the National Institutes of Health to review trial data for all the major coronavirus vaccines supported by the federal government. It says the company’s decision to use early data that puts the vaccine in the most favorable light is a scientific misstep that could erode trust in the shot."

https://www.washingtonpost.com/world/astrazeneca-oxford-vaccine-concerns/2021/03/23/2f931d34-8bc3-11eb-a33e-da28941cb9ac_story.html

In the end, the result did not significantly differ from the earlier announcement. In fact, in one respect it went up. So there we are. It was a highly irresponsible action taken by the agency. These things have always been discussed in private. It's absolutely unprecedented. What you have posted is one side of the story only imo. The British press is telling another.

On another point, this trial was not done on AZ's optimal dosage of a delayed second dose. It probably would have nudged the 90's. This is now the only vaccine that has done 2 major trials.

rabas · March 26, 2021

6 hours ago, mommysboy said:

In the end, the result did not significantly differ from the earlier announcement. In fact, in one respect it went up. So there we are. It was a highly irresponsible action taken by the agency. These things have always been discussed in private. It's absolutely unprecedented. What you have posted is one side of the story only imo. The British press is telling another.

On another point, this trial was not done on AZ's optimal dosage of a delayed second dose. It probably would have nudged the 90's. This is now the only vaccine that has done 2 major trials.

"This is now the only vaccine that has done 2 major trials."

And got caught misrepresenting the data both times. The issue from the beginning is not exact efficacy, trials cannot be so precise. It's about corporate ethics. Did you notice there are ethics experts on the evaluation committees? There is a reason, governments and big corporations don't care about slightly lower efficacy. But, they care very much about corporate ethics when billions of dollars and national security are involved. That's the issue and it is a serious one.

lopburi3 · March 26, 2021

9 hours ago, mommysboy said:

In the end, the result did not significantly differ from the earlier announcement. In fact, in one respect it went up. So there we are. It was a highly irresponsible action taken by the agency. These things have always been discussed in private. It's absolutely unprecedented. What you have posted is one side of the story only imo. The British press is telling another.

On another point, this trial was not done on AZ's optimal dosage of a delayed second dose. It probably would have nudged the 90's. This is now the only vaccine that has done 2 major trials.

It is a bit hard to have much sympathy, even with the low price pledge. This is the same company selling a daily cancer treatment pill at about $500 (Tagrisso) each to those with no options.

david555 · March 26, 2021

On 3/20/2021 at 9:46 AM, Pib said:

The AstraZeneca vaccine is probably not the most effective but it's low cost and easy to store which is important for many parts of the world. Personally, I would like to get the Moderna or Pfizer vaccinee....hopefully they will become available in Thai private hospitals over the coming months but at a price.

https://www.bbc.com/news/world-asia-china-55212787

And here another one , original source of graphic is "The Lancet" well known medical society publication paper

Graphic to find on page of this link :

https://www.express.co.uk/news/politics/1414004/Phillippe-Lamberts-AstraZeneca-vaccine-EU-latest-coronavirus-BBC-Radio-4-update-vn

mommysboy · March 27, 2021

On 3/26/2021 at 9:25 AM, david555 said:

And here another one , original source of graphic is "The Lancet" well known medical society publication paper

Graphic to find on page of this link :

https://www.express.co.uk/news/politics/1414004/Phillippe-Lamberts-AstraZeneca-vaccine-EU-latest-coronavirus-BBC-Radio-4-update-vn

Out of date and inaccurate.

david555 · March 27, 2021

11 hours ago, mommysboy said:

Out of date and inaccurate.

So ....you don't trust your own English famous respected leading medicall publisher for decades ?

Just about Sputnik vaccine ..... they are not breaking down A.Z. .... so dont worry ????, it is only an evaluation of that Russian vaccine ....

Quote from a poster abot Sputnik vacc. with medicall reference from "The Lancet " :

"I agree with you on Sputnik though, the Lancet study on that is encouraging."

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00191-4/fulltext

Link to that posters quote :

https://forum.thaivisa.com/topic/1210942-eu-blames astrazeneca as-vaccine-battle-with-uk-deepens/?do=findComment&comment=16345134

Edited March 27, 2021 by david555

mommysboy · March 28, 2021

On 3/27/2021 at 9:17 PM, david555 said:

So ....you don't trust your own English famous respected leading medicall publisher for decades ?

Just about Sputnik vaccine ..... they are not breaking down A.Z. .... so dont worry ????, it is only an evaluation of that Russian vaccine ....

Quote from a poster abot Sputnik vacc. with medicall reference from "The Lancet " :

"I agree with you on Sputnik though, the Lancet study on that is encouraging."

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00191-4/fulltext

Link to that posters quote :

https://forum.thaivisa.com/topic/1210942-eu-blames astrazeneca as-vaccine-battle-with-uk-deepens/?do=findComment&comment=16345134

The Sputnik vaccine is fine.

The AZ vaccine is now used in the UK with a delayed second dose- 76% first dose/82% second.

JJ's evaluation is against moderate infection and not symptomatic infection (It's a good one though as it went through a very stiff trial, unlike the earlier vaccines).

For that matter, AZ faced a stiff US trial too, and at a sub-optimal regime (dose 4 weeks apart).

Hence, yes, out of date and inaccurate.

david555 · March 29, 2021

13 hours ago, mommysboy said:

The Sputnik vaccine is fine.

The AZ vaccine is now used in the UK with a delayed second dose- 76% first dose/82% second.

JJ's evaluation is against moderate infection and not symptomatic infection (It's a good one though as it went through a very stiff trial, unlike the earlier vaccines).

For that matter, AZ faced a stiff US trial too, and at a sub-optimal regime (dose 4 weeks apart).

Hence, yes, out of date and inaccurate.

Come on bad looser as Sputnik ranked before AZ. ! Did it hurt soo much ????....go cry now to mummy .....????????????

lopburi3 · March 30, 2021

And today:

Quote

Canada is suspending use of the AstraZeneca coronavirus vaccine for people under 55 due to concerns that the shot could cause blood clots, ABC News reports.

https://www.axios.com/astrazeneca-canada-covid-vaccine-suspended-3aedc4a0-e863-47df-80da-7f59eb5fe45f.html

Quote

Immune response may be linked to AstraZeneca vaccine clot issue; death risk rising among young adults in Brazil

https://news.yahoo.com/immune-response-may-linked-astrazeneca-201408822.html

mommysboy · March 30, 2021

1 hour ago, lopburi3 said:

And today:

https://www.axios.com/astrazeneca-canada-covid-vaccine-suspended-3aedc4a0-e863-47df-80da-7f59eb5fe45f.html

https://news.yahoo.com/immune-response-may-linked-astrazeneca-201408822.html

The blood clot issue with AZ (if there is one) is not linked to the sudden upsurge of deaths in Brazil is it?

Note: there have been no incidences in Canada.

I think it's a good decision though, and think giving any vaccine to healthy young people is not needed (yet) in most countries, and should proceed only after a year or so.

mommysboy · March 30, 2021

This is one of the better articles on the subject of Immune thrombocytopenia.

It should ne noted that this is a condition specific to a very small subset of likely immune compromised people- so it's not so much a case of what's wrong with the vaccines as what's wrong with the people.

The warning also applies to the Pfizer vaccine.

https://www.abc.net.au/news/health/2021-03-25/covid-19-astrazeneca-pfizer-vaccines-blood-clots-recommendation/100027624

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