Reanalysis of mRNA Covid Vaccine Phase 3 Trial Data

New study released in peer review Japanese medical journal by experts from US, Spain & Australia.
In 1976 Swine Flu withdrawn when was discovered it had 1 adverse effect in 100,000.
You may remember the FDA wanted to sit on this data for 75 years. A judge ruled that they had to release it. But the FDA has been dragging its feet in the release. In any case these experts finally got the data & analyzed it.

Covid mRNA adverse effects were 1 in 800. Supported & pushed by national government. The authors of the article reviewing the trial data feel a full adverse effect/benefit study should be made. Unfortunately for such a study to be made the participant data has to be released. The FDA & Moderna & Pfizer are sitting on the data & wont release it.

WHY?

Questions?

Why a Japanese medical journal? Was the study rejected US/UK medical journals? If rejected what reasons were given?

A significant portion of the FDA budget is funded by pharmaceutical corporations. Has that fact influenced FDA refusal to release participant information?

Does the participant data reveal that certain medical conditions were linked to adverse effects?

The video was released New Year”s Eve. Will the main stream media report upon this new study?

Significant news story? Or just a part of tj’s conspiracy world?

I’ve listened to this fellow’s YouTube videos over the 18 months in regard to Covid. I think he provided good information. This particular video is quite different as it is sensational & controversial.
His videos:

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This post doesn’t violate any METAR rules. But I wish that you would keep conspiracy theories off of METAR.

Wendy

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Well, if someone has been following a YouTuber for an extended period and still thinks that person is providing good information, I reckon conspiracy theories have to be a regular part of their reality.

John Campbell has crossed my radar screen a few times since the start of the pandemic…oftentimes in the context of some contrarian point of view and presented with a veneer of hokey plausibility from his dining room table. The passage of time, rather than any need for fact checking, has demonstrated the implausibility of much of what he’s said. Still…

Manifestly someone who doesn’t follow TWiV

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Science Direct to description of study:

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

### Discussion

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

Dataset for the above:

Portion from a letter from those involved in the study:
*Last week, along with an international group of physicians and scientists, we published a study suggesting that the risks of COVID-19 vaccines may be greater than previously reported. Using publicly available data from PQzer and Moderna studies, we found one serious adverse event for each 800 vaccinees. *

We believe that scientists have a responsibility to report suspected hazards to authorities.

For sure, many colleagues pushed back against our report. Some asked why we concentrated on the randomized clinical trials when hundreds of millions of people have now received vaccines. For many physicians, randomized trials remain the gold standard for evaluating pharmaceutical products. Vioxx and postmenopausal hormone therapy are two examples of widely used drugs that were only accepted as harmful after large clinical trials examining harms were performed.

Regrettably, our analysis was hindered by an addressable problem: The individual level data that could conQrm or refute our analysis have not been made public. For example, we would have greater conQdence in our conclusions if we knew how often individuals experienced multiple serious adverse events. PQzer, Moderna and the FDA have these data, but have kept them hidden from public view. This information is essential to the understanding of the balance between vaccine beneQts and harms. We are calling upon PQzer, Moderna and the FDA to release all information needed for a comprehensive assessment of these products.

Robert M Kaplan is an Emeritus Distinguished Professor at the UCLA Fielding School of Public Health and an Adjunct Professor of Medicine at Stanford University’s Clinical Excellence

Perhaps not a conspiracy theory. But a true with holding of information.

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Deja vu all over again, as they say. Starting of the New Year with another iteration of Doshi et. al.'s anti vaccine “expose”.

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Veenee,

Nice catch. I maybe the only one liking the truth with you. Well there are a few others…that like the truth…

Yes the study is attacked due its apparent support for the anti vaxer position utilizing a statement “Last week, Peter Doshi managed to expand his penchant for deceptive “reanalyses” to Vaccine, one of the foremost journals about vaccine science,”. No links or proof linking studies authors to Doshi-whoever the hell he is. Just how did Machevellian Doshi cause this study to happen?
Nope we don’t like what the sea so link it anti vaxers.

We do know how money has perverted politics and the health care system and defense procurement . And perhaps vaccine development?
Always follow the benjamins.is my motto.
tj who did get the Covid vaccines. But is now saying hmmm.

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Proofread, proofread, proofread
Nope we don’t like what the “hear” so link it anti vaxers.

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That was not the case at all. The study was not attacked at all.

You are misconstruing the study. That was attacked because putting things on this board that are not true gets questioned. Attacked is only your word for it.

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Well, it’s not that good a catch. There were a series of link dumps to this Doshi paper in a Covid thread recently. Maybe everyone else is too hung over from last night to spot it this early.

This paper first hit the cyber world months ago as a pre-print…so it hadn’t even gone through any sort of editorial review at the time. Naturally, it was promoted mightily by the anti vaxx community and conspiracy theorists in general. The passage of time has refuted the assertions, of course, in that both vaccines have been demonstrated to be effective and the dire warnings (actually, more like broad hints) of serious adverse reactions…some of which, as folk might recall … *also" appeared in the placebo arm. This impediment has quieted the authors any, mind.

Just like playing whack-a-mole…you can’t keep a good conspiracy theory/theorist down.

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He’s the senior author. Didn’t you notice that?

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That’s rich!

and richer with 20 characters

ah that is why it is not in a major journal.

Folks some of the journals are not peer reviewed. I do not know in full in this case.

Either way the list of health problems were not all linked to the vaccine. Most of them were just life going on in general.

But Veenee, I did not want to put time into this so I need to exit because I am not going to read all the links. I am not in the know. I am in the middle of a major project taking a break to be here.

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It has, apparently, appeared in the BMJ … which, granted, doesn’t quite have the stature of Science, Nature or the New England Journal of Medicine (my husband calls it a community magazine for retired GPs) Still, it’s not The Daily Mail, either, so you’d expect a bit more editorial oversight, wouldn’t you. Except that Peter Doshi has some sort of associate editor gig there and is given to using the Opinion sounding board as a mouthpiece for a whole load of anti vaccine mythinformation that’s not restricted to Covid.

It is not really material that it has been reviewed in this case.

The dispute is over how health problems are counted in those who have been vaccinated. The paper counted every health problem which is perfectly okay. But mischaracterizing everything cited as vaccine caused is very confusing to the true believers.

This is the best part.

** After all, well over 12 billion doses have been administered since then, and numerous countries have safety and efficacy data. Say what you will about Peter Doshi’s “reanalysis” of the clinical trial data in January 2021 that falsely concluded that the Pfizer vaccine had only demonstrated 19% efficacy, in January 2021 the randomized clinical trial data for the vaccine was all that there was. It made sense to look at those data then. Today? Not nearly as much.**

For any of this conspiracy to be true than every government in the world would have to be involved, every scientist and doctor would have to be involved. Why isn’t Peter using today’s data from any country out there? Are they all hiding the data? Why would you go back to 2021 to look over old data when so many people have been vaccinated. When you put it that way the whole conspiracy starts to unravel.

Andy

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Except…the conspiracy theories always have a “non zero” rec count. Hard to fathom looking back…but Andrew Wakefield’s anti-vaxx tomfoolery was equally hard to counter with simple logic. What am I saying, even though he’s been shown to be a fraud and he’s been struck off the medical register in the UK, he’s still the darling of the anti-vaxx contingent!

Ya can’t make this steatorrhea up!

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Yes I did miss he was 1 of the 6 involved.

Still why not release the data for full transparency as the American taxpayer paid for the development of the vaccine? Independent experts with no skin in the game can analysis the data and make a report. Then the charlatans if there are any are exposed. If Doshi is distorting data he will be run out of the academic community. If adverse side effects data is much higher then–oh oh the public has been hosed again. WE need to see the original data prior to the approval of the vaccine.
Trust but verify.
The FDA originally wanted to withhold all information for 75 years. 75 years! That is sounding like the Warren commission files still not released. Actions like that, lack of transparency, drive conspiracy theories.

In the past such as COX 2 Inhibitors commercial distortion & fraud rises it’s ugly head to cause the removal of said drugs.
Medical journals have been infected with conflict of interests by pharmaceutical industry.

https://ahrp.org/medical-journals-complicit-in-corruption-of-medicine/
but physician-scientists, academic institutions, and medical journals are all invested in “keeping up appearances” rather than preserving the integrity of science, and honest medicine, we were ridiculed or dismissed as being “anti-science.”

We are no longer “blowin’ in the wind.” A growing number of prominent physician-scientists, including several former journal editors, and New York Times columnists, have written sobering critiques about the corrupting impact pharmaceutical industry influence has had on medicine.

Dr John Abramson quit medicine 20 years because he no longer had faith on what was written in Medical journal. Subsequently wrote a book:" Overdosed America: The Broken Promise of American Medicine"

At the heart of the crisis, he found, lies the changed purpose of medical knowledge—from seeking to optimize health to searching for the greatest profits. The lack of transparency that has become normal in commercially sponsored medical research now taints the scientific evidence published in even our most prestigious medical journals. And unlike the recent scandals in other industries that robbed Americans of money and jobs, this one is undermining our health.

Commercial distortion pervades the information that doctors rely upon to guide the prevention and treatment of common health problems, from heart disease to stroke, osteoporosis, diabetes, and osteoarthritis.

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Conspiracy theories are irrefutable, to people who want to believe them. How many times was a certain birth certificate disclosed, yet people still kept demanding it be disclosed, because they didn’t like what it said.

Steve

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[quote="tjscott0, post:18, topic:85538
Still why not release the data for full transparency as the American taxpayer paid for the development of the vaccine? Independent experts with no skin in the game can analysis the data and make a report. Then the charlatans if there are any are exposed. If Doshi is distorting data he will be run out of the academic community. If adverse side effects data is much higher then–oh oh the public has been hosed again. WE need to see the original data prior to the approval of the vaccine.
Trust but verify.
[/quote]

I agree with tj.
Release the data. Let anyone who is interested, access the data, analyze it their way, present their conclusions, and then let society discuss.

Hiding the data, refusing to release it, etc, just promotes the paranoia.

Me - I got all the COVID vaxes issued to date.
Shingles, flu, measles, etc, too. If they offer a vax, I’m ready to " trust"… But at the same time I DO like the “but verify” recommendation, too.

:tanabata_tree:
ralph

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