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Posted
7 hours ago, FritsSikkink said:

The evidence isn't real strong yet:

What We Know About AstraZeneca’s Head-Scratching Vaccine Results
AstraZeneca’s new clinical trial results are positive but confusing, leaving many experts wanting to see more data before passing final judgment on how well the vaccine will work.

AstraZeneca’s Covid-19 Vaccine: What You Need to Know - The New York Times (nytimes.com)

Posted (edited)
2 hours ago, placeholder said:

The evidence isn't real strong yet:

What We Know About AstraZeneca’s Head-Scratching Vaccine Results
AstraZeneca’s new clinical trial results are positive but confusing, leaving many experts wanting to see more data before passing final judgment on how well the vaccine will work.

AstraZeneca’s Covid-19 Vaccine: What You Need to Know - The New York Times (nytimes.com)

 

That's only true in part.  There were two arms using different doses: one produced 62% efficacy, the other 90%.  It's true that we can't definitively say it works brilliantly yet because of the relatively low numbers in the 90% arm, but we can categorically say it will work to the standard of the average flu vaccine even in the worst case scenario.

Edited by mommysboy
Posted
On 11/20/2020 at 9:46 PM, partington said:

No. It's a double-blinded trial (neither the vaccinated or the vaccinators are told who has a placebo and who has the real vaccine) until a separate set of people unblind the results.

 

The study protocol states clearly before the trial starts exactly when and under what conditions the results can be unblinded.

 

For example when a specifically pre-stated number of subjects have become infected [in the Pfizer vaccine's case this was 94, I believe].

 

The Oxford group don't know when their pre-stated conditions will be met, so have no control over when they are allowed to unblind the data.

 

It was single-blinded. 

 

Anecdotally, it would appear that the researchers were also aware that a dosing error had occurred from analyzing reported milder symptoms in some of the vaccine group.

 

I defer to your greater knowledge however- just asking.

Posted
Just now, sammieuk1 said:

Only 28 miles to Oxford for me lets get suringing and then double the price for Thais just to make them feel not left out ????

 

It's going to be produced in Thailand according to the news publication whose name may not be quoted.

Posted
1 minute ago, mommysboy said:

 

It's going to be produced in Thailand according to the news publication whose name may not be quoted.

In that case treble the price plus a luxury tax ????

  • Like 1
Posted
46 minutes ago, mommysboy said:

 

It was single-blinded. 

 

Anecdotally, it would appear that the researchers were also aware that a dosing error had occurred from analyzing reported milder symptoms in some of the vaccine group.

 

I defer to your greater knowledge however- just asking.

Certainly the protocol for the US arm of the trial is double-blinded, and it would be very odd for the others not to be.   https://www.nih.gov/news-events/news-releases/phase-3-clinical-testing-us-astrazeneca-covid-19-vaccine-candidate-begins

 

"The NIAID COVID-19 Prevention Network (CoVPN)(link is external) will participate in the Phase 3 clinical trial of AZD1222   [The Oxford  AstraZeneca vaccine] in the U.S.

 

[...]

Ann R. Falsey, M.D., professor of medicine, University of Rochester School of Medicine in New York, and Magdalena E. Sobieszczyk, M.D., associate professor of medicine at Columbia University Medical Center in New York, will serve as coordinating investigators for the trial.

Volunteers 18 years and older are eligible and must provide informed consent to participate in the trial. Participants will be randomly assigned to the investigational vaccine group or the placebo group, and neither the investigators nor the participants will know who is assigned to which group. After an initial screening, participants will receive two injections of either the investigational vaccine or a saline placebo approximately four weeks apart. One person will receive a placebo injection for every two people who receive AZD1222, which will result in approximately 20,000 people receiving the investigational vaccine and 10,000 people receiving a placebo."

Posted (edited)

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has initiated the accelerated rolling review of AstraZeneca’s potential vaccine to treat Covid-19.

 

https://www.pharmaceutical-technology.com/news/uk-rolling-review-astrazeneca/

 

I think the key here is 'rolling review'.

 

The UK and Brazil trial arms are altogether more sophisticated perhaps, and allow for instance for the discovery of better dosing regimes (although the 90% discovery appears to have happened more by way of happy error).  I think the MRHA has the information which ensures that the researches can not tamper with evidence so to speak, thus ensuring the integrity of the trials. I believe this trial seeks to answer or at least initially addresses other issues such as comparisons in disease progression between groups. 

 

I don't know if 'odd' is the right word; 'unconventional' perhaps.

 

I don't think the integrity of the study is in question at all.

 

I do note again that you likely know much more about this subject than I.

 

 

 

 

 

 

 

 

 

Edited by mommysboy
Posted
11 minutes ago, mommysboy said:

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has initiated the accelerated rolling review of AstraZeneca’s potential vaccine to treat Covid-19.

 

https://www.pharmaceutical-technology.com/news/uk-rolling-review-astrazeneca/

 

I think the key here is 'rolling review'.

 

The UK and Brazil trial arms are altogether more sophisticated perhaps, and allow for instance for the discovery of better dosing regimes (although the 90% discovery appears to have happened more by way of happy error).  I think the MRHA has the information which ensures that the researches can not tamper with evidence so to speak, thus ensuring the integrity of the trials. I believe this trial seeks to answer or at least initially addresses other issues such as comparisons in disease progression between groups. 

 

I don't know if 'odd' is the right word; 'unconventional' perhaps.

 

I don't think the integrity of the study is in question at all.

 

I do note again that you likely know much more about this subject than I.

 

 

 

 

 

 

 

 

 

I don't claim to be any sort of expert in clinical trial protocols and procedures , only to have a passing knowledge of how they are done.

 

However I don't think regulators" initiating a rolling review" means any aspect of the trial protocol or blinding conditions changes at all. It means the process of approval has been altered.

 

So the MHRA, tasked with approving  treatments,  considers and discusses results of the trial as they come out, rather than waiting a predetermined time for an end stage committee . This is to speed up the process of approval, but does not alter when and where the results of stages the trial can be made known.

 

The investigators in the trial are still bound by the initial protocol for the trial unless an application is made and approved to change that protocol.

 

  • Like 1
Posted (edited)
7 hours ago, mommysboy said:

 

It was single-blinded. 

 

Anecdotally, it would appear that the researchers were also aware that a dosing error had occurred from analyzing reported milder symptoms in some of the vaccine group.

 

I defer to your greater knowledge however- just asking.

While I don't know anything about the trial's specifics, the researchers would have calculated and known the dose in a double blind study. They would also monitor or be made aware of patients' side effects. As you say, putting 2 and 2 together they realized the dosing error. This alone would not indicate it was not a double blind study.

 

The word error is a bit curious. It could be they were simply concerned the dose was too low because of the mild symptoms and decided to use more. In retrospect, that may have been the true error.

 

Edited by rabas
  • Like 1
Posted
3 hours ago, rabas said:

While I don't know anything about the trial's specifics, the researchers would have calculated and known the dose in a double blind study. They would also monitor or be made aware of patients' side effects. As you say, putting 2 and 2 together they realized the dosing error. This alone would not indicate it was not a double blind study.

 

The word error is a bit curious. It could be they were simply concerned the dose was too low because of the mild symptoms and decided to use more. In retrospect, that may have been the true error.

 

As explained by Andrew Pollard, it was a pure mistake on the first dose. Having discovered it, they proceeded with the second dose as planned.

Posted
8 hours ago, from the home of CC said:

they have created a container which once loaded (trays containing 970 doses) will maintain the necessary temp for 20 days, fill a cargo plane and away you go..

 

It's a logistical nightmare to roll out otherwise brilliant vaccines.  It think it can probably be done in the UK, and particularly lends itself to small, first world countries, and a regional approach in the USA would be best to my way of thinking, using a well trained mobile team.  There would be quite a bit of trial and error, I imagine.

 

Initially, it just doesn't cut muster for a mass vaccination program in most of the world, because of the expense and probable complexity.  

 

I do believe that given a year or so, they will have cracked it.  There is still the expense though.

 

The Oxford vaccine is itself far from brilliant, but ticks all the other boxes perfectly.  If the dosage is now right (it looks that way) then it's a no brainer at present despite being an inferior vaccine.

  • Like 1
Posted

We shouldn't lose sight that the primary goal of all these vaccines is to stop people getting very sick, ending up in hospital, and dying.

 

Absolute protection is great of course, but if any vaccine mitigates the severity of infection in individuals then it's job done.  Essentially it becomes a common cold.

 

 

 

 

  • Like 1
Posted
5 hours ago, mommysboy said:

 

It's a logistical nightmare to roll out otherwise brilliant vaccines.  It think it can probably be done in the UK, and particularly lends itself to small, first world countries, and a regional approach in the USA would be best to my way of thinking, using a well trained mobile team.  There would be quite a bit of trial and error, I imagine.

 

Initially, it just doesn't cut muster for a mass vaccination program in most of the world, because of the expense and probable complexity.  

 

I do believe that given a year or so, they will have cracked it.  There is still the expense though.

 

The Oxford vaccine is itself far from brilliant, but ticks all the other boxes perfectly.  If the dosage is now right (it looks that way) then it's a no brainer at present despite being an inferior vaccine.

no thanks..

Posted
2 hours ago, from the home of CC said:

no thanks..

 

Freedom of choice is important. And nobody should be made to take a vaccine they don't trust, or any vaccine at all for that matter.  However, imo not taking a safe and effective vaccine because it is not as good as another which is not available would be a pretty silly decision. 

Posted (edited)
19 minutes ago, cormanr7 said:

There is an obvious (well, not to most) problem with the Astra Zeneca data: they claimed that two full doses resulted in an efficacy of 62%, whereas the half plus full dose gave 90%. OVERALL, the claimed efficacy was 70%. This suggests that the half plus full dose group was much smaller. So basically there are two trials. The age distribution in the two groups have not been shown either. Were the elderly actually protected in the half plus full dose? 

Summarizing, the data are far too vague and a full disclosure of all available information should be made.

2,741 participants were given the half-dose/full-dose regimen and 8,895 participants were given the two-full-dose regimen. Now it appears there were significant differences between the two groups.

 

https://arstechnica.com/science/2020/11/astrazenecas-best-covid-vaccine-result-was-a-fluke-experts-have-questions/

 

AstraZeneca and Oxford have been mum about how that error occurred exactly. Meanwhile, outside experts have raised doubt about whether the 90 percent efficacy is even real, given the smaller number of participants.

 

the dosing error occurred early in the trial when researchers were only recruiting people between the ages of 18 and 55—excluding older people more vulnerable to disease. The analysis with the two-full doses, on the other hand, did include older age groups.

 

Edited by rabas
  • Like 1
Posted
16 minutes ago, rabas said:

2,741 participants were given the half-dose/full-dose regimen and 8,895 participants were given the two-full-dose regimen. Now it appears there were significant differences between the two groups.

 

https://arstechnica.com/science/2020/11/astrazenecas-best-covid-vaccine-result-was-a-fluke-experts-have-questions/

 

AstraZeneca and Oxford have been mum about how that error occurred exactly. Meanwhile, outside experts have raised doubt about whether the 90 percent efficacy is even real, given the smaller number of participants.

 

the dosing error occurred early in the trial when researchers were only recruiting people between the ages of 18 and 55—excluding older people more vulnerable to disease. The analysis with the two-full doses, on the other hand, did include older age groups.

 

Thanks for this additional info. So actually it is possible that the high efficacy in the half plus full dose is a coincidence.  

Posted (edited)
3 hours ago, cormanr7 said:

Thanks for this additional info. So actually it is possible that the high efficacy in the half plus full dose is a coincidence.  

 

Being young, thin, etc, doesn't stop you getting infected!  It stops you getting badly ill (probably).  So no. I wouldn't have thought so.

 

Actually, young people are more likely to get infected , because of work and lifestyle choices.

 

Important points about these vaccines:  even if they fail to prevent infection they will very likely reduce the severity of the infection- this is why the flu jab is so useful despite being only 60% effective at stopping infection.  This translates to far fewer serious infections and hospitalizations.

 

 

 

 

 

Edited by mommysboy
Posted
27 minutes ago, mommysboy said:

 

Being young, thin, etc, doesn't stop you getting infected!  It stops you getting badly ill (probably).  So no. I wouldn't have thought so.

 

Actually, young people are more likely to get infected , because of work and lifestyle choices.

 

Important points about these vaccines:  even if they fail to prevent infection they will very likely reduce the severity of the infection- this is why the flu jab is so useful despite being only 60% effective at stopping infection.  This translates to far fewer serious infections and hospitalizations.

The trials would tend to ignore work and lifestyle type factors affecting exposure. The logic goes like this.

 

Given that you are infected, did you take the vaccine or not?

 

Since they know the percentage vaccinated, they presumably know the efficacy. The total number of infected is not a factor. As the trial runs longer, more will be infected but the efficacy should remain roughly the same.  If a younger group shows better efficacy it could be due to several factors, including stronger  immune systems.

Posted (edited)
5 minutes ago, rabas said:

The trials would tend to ignore work and lifestyle type factors affecting exposure. The logic goes like this.

 

Given that you are infected, did you take the vaccine or not?

 

Since they know the percentage vaccinated, they presumably know the efficacy. The total number of infected is not a factor. As the trial runs longer, more will be infected but the efficacy should remain roughly the same.  If a younger group shows better efficacy it could be due to several factors, including stronger  immune systems.

 

Yes, I see.

 

I was just drawing a distinction between getting infected and being more vulnerable to the effects of the disease.  Because of what I see as a potential misunderstanding in logic:

 

Another wrinkle is that the dosing error occurred early in the trial when researchers were only recruiting people between the ages of 18 and 55—excluding older people more vulnerable to disease. The analysis with the two-full doses, on the other hand, did include older age groups.

 

There is the danger, as with this poster, that younger adults are assumed to be not at the same risk of infection, which I think is probably untrue.

 

You can equally contend that younger age groups could be stated as being more vulnerable to infection, but not the serious effects of disease,  whereas in older age groups it could be vice-versa.  Younger age groups have an active lifestyle, are more likely to be in front line jobs, and indulge in large or confined gatherings, such as parties.

 

As far as I'm aware,  the percentages quoted are of infection rate.

Edited by mommysboy
Posted
20 hours ago, mommysboy said:

 

Freedom of choice is important. And nobody should be made to take a vaccine they don't trust, or any vaccine at all for that matter.  However, imo not taking a safe and effective vaccine because it is not as good as another which is not available would be a pretty silly decision. 

safe and effective?

https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/

Posted
On 11/12/2020 at 6:53 PM, 3NUMBAS said:
Health

Oxford coronavirus vaccine expected to be easier to roll out than Pfizer jab

 

https://uk.news.yahoo.com/oxford-coronavirus-vaccine-expected-easier-175246355.html

 

The Oxford vaccine is expected to be easier to store and distribute throughout the UK than the Pfizer jab - if and when it is proved to be safe and effective.

No 10 has ordered millions of doses from the two leading candidates, with experts saying that the government will need a “toolbox” of vaccines to bring the pandemic under control, though concern has been raised over the logistical challenges of storing and transporting the Pfizer jab.

The vaccine needs to be kept at -70C up until the day it is used to maintain the integrity of the doses’ genetic material.

This is expected to complicate the rollout of doses to GP clinics and care homes, which do not have the refrigerator technology required to maintain such low temperatures.

Because of this, the Oxford vaccine - which can be stored at between 2C and 8C - is expected to be easier to administer in the community and therefore provider the bedrock of the UK’s vaccination programme.

Whereas Pfizer’s jab makes uses of cutting-edge RNA technology to provoke an immune response in humans, the Oxford vaccine utilises an engineered viral vector to train the body in neutralising any future infection from Sars-CoV-2 - the virus that causes Covid-19.

couldn't pay me enough to put this in my arm..

https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/

 

 

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