Covid vaccines - thread banned users in First Post

Hoop66

No

hometruths

https://www.boards.ie/discussion/comment/119207347#Comment_119207347

Ok, that's no problem, nobody else has been able to do so either.

Dohnjoe

Went to a popular conspiracy forum there and had a look. About 80% of current posts are anti-vax related.

It's bad enough thinking you know more than medical professionals and science, but it's quite another not noticing that your views are shared by the biggest fruitcakes in the world..

Dohnjoe

https://www.boards.ie/discussion/comment/119207347#Comment_119207347

"Yes but if you could help me understand this thing that I've spent hundreds of posts openly trying not to understand"

buzzerxx

Many of you know that something is terribly wrong with everything that's happened the past 2+ years but you're either too afraid to speak, too apathetic, being paid to shill or have too much pride to admit that you were wrong and were fooled to go along with it. And because of that, it continues.

astrofool

https://www.boards.ie/discussion/comment/119206904#Comment_119206904

Nothing is going over anyone's head but yours.

The table was included for completeness sake, it doesn't include the data on severity, it does include the 95% efficacy against symptomatic infection.

The secondary table includes the severity data with a 66% efficacy and wide confidence interval, that confidence interval narrowed quickly as other trial results came in and the reasoning for the approval against severity was also included in the document:

In the evaluable efficacy population, subjects without evidence of prior SARS-CoV-2 infection, the estimated VE against severe COVID-19 occurring at least 7 days after dose 2 was 66.4% (95% CI: - 124.8%: 96.3%). The posterior probability for the true VE greater than 30% is 74.29% (7 days) and 74.32% (14 days), which did not meet the pre-specified success criterion for this endpoint, therefore no reliable conclusion can be drawn at this stage. While data on severe COVID-19 are limited, the experience with other vaccines (rotavirus and influenza vaccines with known efficacy against mild disease but better efficacy against severe disease) coupled with the high observed vaccine efficacy observed for BNT162b2 on all COVID-19 cases in populations with any comorbidity gives reassurance that the vaccine is likely to prevent severe disease. However, a precise estimate of its protective effect is presently lacking. The final study report may include additional data to the extent that the study is continued in a randomised fashion with a placebo group.

Again, this hasn't been answered correctly as you've veered off into numerous crazy tangents, try and be coherent this time (I've included the reason again above, let's see if you pick it up this time):

Why did I include the sentence you were hiding, the paragraph of uncertainties and the table? The answer is in this post. The answer you want from Hoop66's question is also in this post.

Let's see if you can decipher any of it, or will you continue to wear the dunce hat.

Dohnjoe

https://www.boards.ie/discussion/comment/119207729#Comment_119207729

Nothing matches the stamina of a fanatic. Some of the 9/11 guys have kept this up for well over 5 years.

Step 1: "No, your explanation makes no sense to me. Here's my original argument all over again."

Step 2: Go to Step 1.

hometruths

https://www.boards.ie/discussion/comment/119207729#Comment_119207729

In order for me to try to answer your question can you please tell me which section of the report the table you originally posted for the sake of completeness relates to ?

Dohnjoe

https://www.boards.ie/discussion/comment/119207728#Comment_119207728

And anyone who finds out about it gets dumped into this forum by the mods and we do the rest. It's better this way.

Fighting Tao

https://www.boards.ie/discussion/comment/119207165#Comment_119207165

You are trolling or else have the lowest IQ in the country. That’s bad given you’ve got stiff competition from some of your fellow conspiracy theorists here.

hometruths

https://www.boards.ie/discussion/comment/119207709#Comment_119207709

Do you understand how, at the time of approval, the data on severity was extremely comprehensive and proven in massive trials?

Dohnjoe

https://www.boards.ie/discussion/comment/119207848#Comment_119207848

Is it possible to explain something to someone who is determined not to understand it?

Because that's the core issue here.

hometruths

https://www.boards.ie/discussion/comment/119207877#Comment_119207877

I didn't ask whether or not it was possible to explain to me.

Is asked whether or not you understand how, at the time of approval, the data on severity was extremely comprehensive and proven in massive trials?

Do you?

hometruths

https://www.boards.ie/discussion/comment/119207791#Comment_119207791

Do you understand this given your superior IQ?

To be helpful, I've quoted the most relevant section of the EMA report below if you want to read it. Both astrofool and I appear to be relying on this same section for our different interpretations.

3.3. Uncertainties and limitations about favourable effects

Based on the available limited data, no reliable conclusion on the efficacy of the vaccine against severe COVID-19 can be drawn from 7 days after the second dose (secondary endpoint). The estimated efficacy against severe COVID-19 occurring at least 7 days after dose 2 was 66.4%, with a large and negative lower bound CI (95% CI: -124.8%; 96.3%). Only a limited number of events occurred at the cut-off date of analysis (1 and 4 cases in the vaccine and placebo groups respectively). The posterior probability for the true vaccine efficacy ≥ 30% (74.29%) did not meet the pre-specified success criterion. Consequently, the efficacy against the severe disease across subgroups, notably certain populations at high-risk of severe COVID-19 cannot be estimated (elderly and subjects with comorbidities).

Efficacy against asymptomatic infection is not available but, notwithstanding all the limitations, will be assessed through seroconversion of N-binding antibodies in BNT162b2 and placebo recipients who did not experience COVID-19.

The pivotal study was not designed to assess the effect of the vaccine against transmission of SARSCoV-2 from subjects who would be infected after vaccination. The efficacy of the vaccine in preventing SARS-CoV-2 shedding and transmission, in particular from individuals with asymptomatic infection, can only be evaluated post-authorisation in epidemiological or specific clinical studies.

Duration of protection has currently been followed up for approximately 100 days after dose 1. Data on longer term protection are anticipated to the extent that the ongoing phase 3 study can continue as planned with a placebo group. The assessment of efficacy over a period of at least 6 months is expected to determine the need and the appropriate time of a booster dose.

There seems to be at least a partial onset of protection after the first dose, but this remains unconfirmed at this stage.

There are very limited or no data in immunocompromised subjects and in pregnant women. Efficacy in subjects aged 16-17 years is extrapolated from young adults as no cases of disease were reported in this small group at this stage.

Available data do not suffice to establish efficacy in subjects seropositive for SARS-CoV-2 at baseline, and subjects with a known history of COVID-19. However, efficacy is anticipated in this group, to the extent that they are not naturally protected against re-infection, which is presently incompletely characterised.

So, what do you think? Do you understand how, at the time of approval, the data on severity was extremely comprehensive and proven in massive trials?

Fighting Tao

https://www.boards.ie/discussion/comment/119208245#Comment_119208245

It has already been explained loads of times times. Having it explained one more time to you will achieve nothing because either you can’t understand or don’t want to understand. I suspect that you choose the path of least education to try and annoy people.

hometruths

https://www.boards.ie/discussion/comment/119208309#Comment_119208309

Again I am not asking you for an explanation.

Forget about whether I understand it, I'm simply asking for a confirmation of whether or not you understand it?

Do you understand how, at the time of approval, the data on severity was extremely comprehensive and proven in massive trials?

It is a simple yes or no question.

Fighting Tao

https://www.boards.ie/discussion/comment/119208325#Comment_119208325

Yeah, I’ve seen this tactic many times before. Try to expand the group of people involved rather than face reality. This forum has plenty of incidents of it. I’m not getting dragged into your trolling. I’ve engaged more than I should. I’ll give you this, usually when a conspiracy theorist is as fucked as you are in your position, they take the ball and go home. You haven’t, but you troll instead.

shillyshilly

https://www.boards.ie/discussion/comment/119208245#Comment_119208245

Yes there was sufficient data... 36,000 who met Primary endpoint (50:50 test of vaccine vs placebo, so over 18,000 had the vaccine, putting it as one of the most tested pre-market vaccines ever).

your favourite quote:

Based on the available limited data, no reliable conclusion on the efficacy of the vaccine against severe COVID-19 can be drawn from 7 days after the second dose (secondary endpoint).

What it is referring to, is not what you are construing it to be.

The secondary endpoint was added to include persons who had been infected with COVID before and during the trial, and was added as there were more and more volunteers being infected before/during the trials .... So their Primary endpoint (COVID free volunteers) would be invalid to include them..(roughly 8,000 in the study).

So please, actually read and understand the full studies you look up and link to.

Also...please look up some basic statistics, your interpretation of CI is painful to read.

odyssey06

https://www.boards.ie/discussion/comment/119208325#Comment_119208325

Irrelevent weasel words.

Your entire strategy on this thread can be summed up in the video below.

My word, what are the chances, we ran a trial on the vaccines, it showed an immune response against a virus, and even as the virus mutates we see the essential immune response persisting.

That's the key takeaway and all that matters.

You've had at least hundred posts on this thread and this pretty much sums up where you are at.

If Chewbacca lives on Endor YOU MUST ACQUIT.

https://www.youtube.com/watch?v=aV6NoNkDGsU

https://en.wikipedia.org/wiki/Chewbacca_defense

hometruths

https://www.boards.ie/discussion/comment/119208366#Comment_119208366

Fine, just so I am not accused of wilfully misunderstanding your explanation are you saying that this in your opinion does equate to the data on severity being extremely comprehensive and proven in massive trials?

Also...please look up some basic statistics, your interpretation of CI is painful to read.

Fair enough I don't claim to be an expert - are you prepared to tell me what is the significance or not of the large and negative range bound. i.e what does this mean in laymans terms?

(95% CI: -124.8%; 96.3%).

kleefarr

Re cancer..

This is the main reason why cancer is so wide spread... https://blog.listentoyourgut.com/glyphosate-is-even-in-the-rain-what-we-can-do/

Fighting Tao

https://www.boards.ie/discussion/comment/119208491#Comment_119208491

Checks the thread….Is cancer also in the covid vaccine?

odyssey06

https://www.boards.ie/discussion/comment/119208504#Comment_119208504

Can't even post the intel in the right thread but has figured out source of cancer. Totally checks out.

shillyshilly

https://www.boards.ie/discussion/comment/119208444#Comment_119208444

It's nothing about opinion.... the study quite clear

The results indicated 95% efficacy over the whole 44,000 sample size...

The study initially set out to have people who never had COVID and had no traces of antibodies in their blood (Primary Endpoint, circa 36,000 people).

However, due to the changing viral demographics over the trial period (it was a pandemic after all), the Secondary endpoint was added to allow people who previously had COVID, or had detectable viral elements in their blood to take part also (circa 8,000 people).

Given the secondary endpoint was not part of the original trial spec, you have to add the "further testing required" caveat. You also raise the question of "how do you know if it was their natural immunity or the vaccine which prevented mild or severe illness"... that question has become numerous studies within itself.

So yes, the trial was comprehensive, it had a huge sample size which adhered to the Primary study specification, and generated data for numerous other studies to continue on with the likes of the secondary outcomes.... like any good piece of scientific research does.

Re: CI .... it is all relevant to the mean of the range you are working in and if you don't have a definite bound, you get negative LL or UL.... so you will see for the likes of the greater than or equal to 65 years old range give a negative LL.... this is because people tend to die at random ages, so there isn't a definitive UL.

This is demonstrated on one of the pages, where the 65+ range is broken down into a 65 to 75 range, (definitive limits and has LL and UL off the top of my head around 80) and the 75+ has a negative LL. If you read the study you would have seen that.

It also gives a negative limit if there is a tiny sample of the sample... so again...if you read the report, there is a breakdown of race, and in one of the studies there was a single Asian person from a sample size of a few thousand.... that produced a negative LL...

astrofool

https://www.boards.ie/discussion/comment/119207750#Comment_119207750

Sure, as you posted yourself, this is what the table was for:

Table 20 Effects Table for Comirnaty intended for active immunisation to prevent COVID19 caused by against SARS-CoV-2 in individuals 16 years of age and older (data cut-off: 14 Nov 2020)

The table clearly showed the vaccine worked by the prevention of COVID-19 (something which you were arguing against in stupid fashion).

Table 12 covers effects against severe disease. Seeing as you're now using the EMA approval as your reference point, you now must accept their severe disease conclusion:

In the evaluable efficacy population, subjects without evidence of prior SARS-CoV-2 infection, the estimated VE against severe COVID-19 occurring at least 7 days after dose 2 was 66.4% (95% CI: - 124.8%: 96.3%). The posterior probability for the true VE greater than 30% is 74.29% (7 days) and 74.32% (14 days), which did not meet the pre-specified success criterion for this endpoint, therefore no reliable conclusion can be drawn at this stage. While data on severe COVID-19 are limited, the experience with other vaccines (rotavirus and influenza vaccines with known efficacy against mild disease but better efficacy against severe disease) coupled with the high observed vaccine efficacy observed for BNT162b2 on all COVID-19 cases in populations with any comorbidity gives reassurance that the vaccine is likely to prevent severe disease. However, a precise estimate of its protective effect is presently lacking. The final study report may include additional data to the extent that the study is continued in a randomised fashion with a placebo group.

Do you disagree with this statement made by the EMA?

Were the trials for SARS-COV2 much larger than other medical trials?

hometruths

https://www.boards.ie/discussion/comment/119208604#Comment_119208604

It's nothing about opinion.... the study quite clear

The results indicated 95% efficacy over the whole 44,000 sample size...

The study initially set out to have people who never had COVID and had no traces of antibodies in their blood (Primary Endpoint, circa 36,000 people).

I'm not arguing about the entire study or the sample size for the results showing 95% efficacy at preventing Covid. I have never disputed that. I will happily agree that the approval for the prevention of Covid was granted because of extremely comprehensive data proven in massive trials.

My point has always been that despite the size of the study, the data relating to efficacy on severity was insufficient because the incidences of severe disease were very rare in the placebo group in the trial. Long before I started quoting the EMA report I quoted the BMJ article on exactly this point quoting the Chief Medical Officer of Moderna as saying:

But Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks adequate statistical power to assess those outcomes. “The trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here,” he said.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.

This is why I am arguing that the data on severity was neither extremely comprehensive or proven. With only a handful of cases of severe covid sure it is the very antithesis of extremely comprehensive and whilst at estimate can be calculated it cannot be described as proven.

Does this make sense to you?

Thanks for the CI explanation, my layman's understanding is the % relates to the level of confidence that the true value will lie within the range of lower and upper limit. Thus a narrower interval is more reliable.

So in this case a 66.4 estimate of efficacy against severity with (95% CI: -124.8%; 96.3%) means the available trial data indicates an estimate of 66.4% and they are 95% confident that the true value lies between -124.8% and 96.3%. Is that correct?

It also gives a negative limit if there is a tiny sample of the sample... so again...if you read the report, there is a breakdown of race, and in one of the studies there was a single Asian person from a sample size of a few thousand.... that produced a negative LL...

is this why the efficacy against severity resulted in a negative limit? the number of severe cases was tiny?

King Mob

Page 250 and still no safety issue is being discussed.

Just hometruths pretending to have a point.

hometruths

https://www.boards.ie/discussion/comment/119208713#Comment_119208713

Seeing as you're now using the EMA approval as your reference point, you now must accept their severe disease conclusion:

Yes I accept their severe disease conclusion and always have done:

While data on severe COVID-19 are limited, the experience with other vaccines (rotavirus and influenza vaccines with known efficacy against mild disease but better efficacy against severe disease) coupled with the high observed vaccine efficacy observed for BNT162b2 on all COVID-19 cases in populations with any comorbidity gives reassurance that the vaccine is likely to prevent severe disease. However, a precise estimate of its protective effect is presently lacking.

Based on the limited data they could not reliably state findings that the vaccine would be effective against severe Covid is my reading of their conclusions. I have said repeatedly there was a clear hope and expectation that it would be likely to be effective, but reassurance that something might be likely is very different from stating that it is proven.

I simply don't understand how it is possible to interpret the above as saying the efficacy was proven with comprehensive data in massive trials.

astrofool

https://www.boards.ie/discussion/comment/119208885#Comment_119208885

Were the trials massive or not?

ShillyShilly has covered the comprehensive piece above.

Yes I accept their severe disease conclusion and always have done

So you have backed down from the "lucky" claim now, seeing as they specifically measured it's effect.

hometruths

https://www.boards.ie/discussion/comment/119209016#Comment_119209016

Leaving aside whether or not the data on severity was comprehensive or the trials were massive for a minute, given the precise estimate lacking conclusion you quoted above are you still arguing that the effect on severity was proven?