Coronavirus Pandemic

Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials

Abstract
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.

Conclusions
A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.

https://www.mdpi.com/1648-9144/57/3/199

Absolute Risk Reduction: Your Secret Weapon in Literature Evaluation

If you spend any amount of time looking at clinical studies or doing literature evaluation, you’ll see the term Relative Risk thrown about liberally. You’ll also see things like Odds Ratio, and Hazard Ratio on the regular.

But you know what you won’t see all that often?

The unsung hero of literature evaluation: Absolute Risk Reduction (ARR).

Simply put, Absolute Risk Reduction is the only way to identify the true context of something reported in a clinical trial. It’s usually a much smaller number than Relative Risk Reduction (RRR), but it helps you assess the real world impact of a study finding.

https://www.tldrpharmacy.com/content/absolute-risk-reduction
I think I made the right decision not to take any of the vaccines :)

David
 
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Hmm... actually most of the top vitamin/nutriceutical brands are already BigPharma, such as Bayer, Pfizer, Glaxo and friends. (e.g. take Centrum Silver which is the one of the largest vitamin manufacturers in the US, owned by Pfizer). No need for a countering force :)

Just to nail down the coffin on this point, a quick GOOGLE shows that:

Cost of one dose of remdesivir is $390.

Cost of a bottle of Vitamin D tablets (the D3 form) is $10, and that contains 120 1-tablet doses.

So Silence, can you now see why a drug company might want to downplay treatment or prevention of COVID by Vitamin D in favour of remdesivir?

David
 
I think I made the right decision not to take any of the vaccines :)

David

You mean you don't want to take part in a the historical unapproved biological genetic immune modulatory experiment with absolutely zero long term safety data? :)

I was never intending to but I thought I would look into the actual information just a little. It is far worse than I had imagined actually. Far beyond a pitiful ARR score, which is used to define the NNTV score (number needed to vaccinate) BTW. Working out to be 142 for Pfizer and 88 for Moderna. Meaning 142 or 88 people need to be exposed to potential harmful side effects in order to prevent one single case of Covid-19!

Efficacy was determined through PCR test showing the antigen to be present. So it is determined by having virus particles present but not if you have a effective T-cell or B-Cell response as a result of the injection.

As already noted the true ARR score was omitted breaching the FDA guidelines for communicating risks and benefits to the public.
 
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Just to nail down the coffin on this point, a quick GOOGLE shows that:

Cost of one dose of remdesivir is $390.

Cost of a bottle of Vitamin D tablets (the D3 form) is $10, and that contains 120 1-tablet doses.

So Silence, can you now see why a drug company might want to downplay treatment or prevention of COVID by Vitamin D in favour of remdesivir?

David
Nail in the coffin? Nice touch.

We can go back to Eric's rather in depth insights into how insurance companies would factor into these market forces as well. (Hint: They don't want to pay $390 for something that could be treated for $10 either.)

There are conflicts of interest in capitalism. Its well known and we deal with it every day. It doesn't automatically mean there's a conspiracy in all cases.

Sorry for loosening the nail. ;)
 
Information from the manufacturer, in this case Pfizer. Information that should be known in order for proper informed consent.

In the event an EUA is issued for this product, it would still be considered unapproved and it would be under further investigation

As specified in the protocol, suspected cases of symptomatic COVID-19 that were not PCR confirmed were not recorded as adverse events unless they met regulatory criteria for seriousness

Unsolicited AEs related to pregnancy include spontaneous abortion and retained products of conception,

"AE" is Adverse effects, "products of conception" in context is a dead fetus!

The only common laboratory abnormality reported throughout the studies was transient decreases in lymphocytes 1-3 days after Dose 1, which increased in frequency with increasing dose,

it is not possible to assess sustained efficacy over a period longer than 2 months.

the subset of certain groups such as immunocompromised individuals (e.g., those with HIV/AIDS) is too small to evaluate efficacy

available data are insufficient to make conclusions about benefit in individuals with prior SARS-CoV-2 infection.

No efficacy data are available from participants ages 15 years and younger.

antigenically significant mutations to the S protein, and/or the effect of coinfections may potentially limit the generalizability of the efficacy conclusions over time.

Data are limited to assess the effect of the vaccine against asymptomatic infection as measured by detection of the virus and/or detection of antibodies

at present it is not possible to assess whether the vaccine will have an impact on specific long-term sequelae of COVID-19 disease in individuals who are infected despite vaccination.

A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality

Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination

Additional evaluations including data from clinical trials and from vaccine use post-authorization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.

The above is highlighted for convenience here in this PDF. Although the entire briefing should be familiar to anyone taking part in the experiment I would think.
https://21a86421-c3e0-461b-83c2-cfe...d/659775_335c5cbb4ad64f40bbca4768acfe0e76.pdf
 
Nail in the coffin? Nice touch.

We can go back to Eric's rather in depth insights into how insurance companies would factor into these market forces as well. (Hint: They don't want to pay $390 for something that could be treated for $10 either.)
I'm not sure what you mean - I googled the price for one dose of remdesivir.
There are conflicts of interest in capitalism. Its well known and we deal with it every day. It doesn't automatically mean there's a conspiracy in all cases.

Sorry for loosening the nail. ;)
Well basically any scam can be called a conflict of capitalism, and I guess most can be called conspiracies. You are just wriggling semantically.

David
 
I'm not sure what you mean - I googled the price for one dose of remdesivir.

Well basically any scam can be called a conflict of capitalism, and I guess most can be called conspiracies. You are just wriggling semantically.

David

Engagement with those whose words support the actual psychopath pseudo-reality is feeding the monster. This forum is infested but there's the lovely ignore feature. Sadly, I suspect a great administrator/moderator cannot use the feature so, I honor you, David and appreciate you and appreciate your stands against the monster(s).
 
I was never intending to but I thought I would look into the actual information just a little. It is far worse than I had imagined actually. Far beyond a pitiful ARR score, which is used to define the NNTV score (number needed to vaccinate) BTW. Working out to be 142 for Pfizer and 88 for Moderna. Meaning 142 or 88 people need to be exposed to potential harmful side effects in order to prevent one single case of Covid-19!

This is simply how vaccines work LS, these are actually very good numbers.

The death rate for confirmed cases is around 2% worldwide
So this one in fifty dies.

This means, for Moderna, that for every (88 . 50 =) 4400 people you vaccinate, you save a life.
For Pfizer this amounts to one life saved for every 7100 people vaccinated.
And that is just the benefit for people vaccinated.

If we take into account the cumulative effect, there is even more to gain.
Think about people not getting infected, and not potentially dying if we get anywhere near herd immunity.

Millions have been vaccinated worldwide with both of these vaccines. Serious side effects are incredibly rare, and certainly not as deadly as the virus.

The difference between relative risk reduction and absolute risk reduction is a red herring.
It is just looking at the same numbers a different way.

For those who actually get the vaccine, it does not change the efficacy of the vaccine for preventing getting infected.
It does not change the test results, they still show that you reduce your personal risk of getting the virus by about 95%, if you get the vaccine of course.

All this drama over lost freedoms, and yet not wanting to parttake in the only solution to get them back, makes no sense at all.

I for one can not wait to get my upgrade vaccine.
 
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Engagement with those whose words support the actual psychopath pseudo-reality is feeding the monster. This forum is infested but there's the lovely ignore feature. Sadly, I suspect a great administrator/moderator cannot use the feature so, I honor you, David and appreciate you and appreciate your stands against the monster(s).
Now I no longer moderate, I do take advantage of the ignore button, but I prefer to tangle with some people explicitly!

David
 
Hard to consider Dr. Pavelsky as an unbiased voice in all this.

https://www.insider.com/anti-vaccine-doctors-medical-license-free-speech-2019-5
What? Because he questions other unsafe vaccines? A doctor who questions the establishment brainwashing unlike most of the stupid parrots makes him an actual doctor. Am too tired to outline things. If anyone wants have posted a few things in this thread which crap all over Silence and Bart's (not saying you are an employed troll Bart unlike Silence) gibberish. The ex vice president of Phizer telling people not to vaccinate (covid-19) healthy people springs to mind as well as the irefutable evidence that almost everyone has had already contracted covid at least once, most people 2-3 times as natural immunity lasts about 6 months
 
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What? Because he questions other unsafe vaccines? A doctor who questions the establishment brainwashing unlike most of the stupid parrots makes him an actual doctor. Am too tired to outline things. If anyone wants have posted a few things in this thread which crap all over Silence and Bart's (not saying you are a troll Bart unlike Silence) gibberish. The ex vice president of Phizer telling people not to vaccinate healthy people springs to mind as well as the irefutable evidence that almost everyone has had already contracted covid at least once, most people 2-3 times as natural immunity lasts about 6 months

 
What? Because he questions other unsafe vaccines? A doctor who questions the establishment brainwashing unlike most of the stupid parrots makes him an actual doctor. Am too tired to outline things. If anyone wants have posted a few things in this thread which crap all over Silence and Bart's (not saying you are an employed troll Bart unlike Silence) gibberish. The ex vice president of Phizer telling people not to vaccinate (covid-19) healthy people springs to mind as well as the irefutable evidence that almost everyone has had already contracted covid at least once, most people 2-3 times as natural immunity lasts about 6 months
Its clear the point was beyond your comprehension Monkey. Get some rest and try again when you have a clear head.
 
Hard to consider Dr. Pavelsky as an unbiased voice in all this.

https://www.insider.com/anti-vaccine-doctors-medical-license-free-speech-2019-5

This is not surprising, and is another complicated can of worms. I understand that simply googling up people to find opinions is far easier than addressing the very real concerns but I don't find it helpful sorry.

His point that we do not have enough data is absolutely true and is clearly admitted in the briefing document highlights I posted above.
This point is in the true spirit of science don't you think?

The next crucial point is that it has never been evaluated that it produces antibody immunity from the injection. Antibodies can be produced but they are not all the same and the mere presence does not equal a adequate defense.

Next point, this technology has never been used in vaccine science before with any kind of success. True as far as I know.

Next, No study done to say that the production of the spike protein is ever turned off. True.

The spike protein has been known to cause a series of conditions (which he mentions). The spike protein is the means in which the virus enters the cell. This is also true.

Since we are delivering the means for creating the spike protein the rest is logically of very real concern and has nothing to do with character assassination.
 
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Here is some related research from Japan to support some of that.

An infectivity-enhancing site on the SARS-CoV-2 spike protein is targeted by COVID-19 patient antibodies
https://www.biorxiv.org/content/10.1101/2020.12.18.423358v1

Here, we screened a series of anti-spike monoclonal antibodies from COVID-19 patients, and found that some of antibodies against the N-terminal domain (NTD) dramatically enhanced the binding capacity of the spike protein to ACE2, and thus increased SARS-CoV2 infectivity.

Basically it is this... the spike protein is what covid uses to enter the cell. First red flag!

When the immune system is exposed to the spike protein regardless of the means,(virus or vaccine) the body produces the antibodies.
These antibodies target different sites on the spike protein.

Here is the thing, some antibodies will knock out the spike protein. Which is what we want.

Some will bind with the NTD segment of the spike protein making it easier to enter the cell making the virus far more infectious! Definitely not what we want!

The Pfizer, Moderna and AstraZeneca vaccines all retain the infectivity enhancing site on the NTD segment.

So these vaccines will produce antibodies that attack the NTD segment.

This will produce what is called vaccine enhanced disease. Yes it is a thing.

I can't be certain but I believe this is why some animal studies produced death when exposed to the wild virus.

I'm still looking into this, but this is what I can say for now.

If this research is solid it is proof the vaccines as they stand are not safe and that at the very least ones must be developed that exclude the NTD domain. Except it seems nothing can derail the freight train of fear and money that has been put in motion.

Speaking personally, given the evidence and especially lack of evidence there is no reason to play Russian roulette in this experiment against a virus that is only a worry for some. Especially when a much safer alternative, ivermectin, is showing growing support and evidence.

Fear is driving this whole thing in all aspects.
 
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Hard to consider Dr. Pavelsky as an unbiased voice in all this.

https://www.insider.com/anti-vaccine-doctors-medical-license-free-speech-2019-5
One of the problems with vaccines, is that they clearly have the potential to do catastrophic harm. What I mean by this, is that they are treatments that are not just given to ill people, they are given to everyone, including children.

Some people think vaccines may be responsible for the huge rise in autism in recent years. Whether that is true or not, it illustrates the real problem in this area. Clearly accepting the blame for such a disaster would be hard for anyone to do - let alone a pharmaceutical company! That fact alone makes it difficult to believe them when they claim to be not guilty!

Giving people vaccines for illnesses that are usually mild, is like playing Russian Roulette. Every time you 'play' it, you risk a disaster.

I have become extremely cautious about treatments given to well people as a preventative measure.

David
 
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