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BMJ Investigation Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

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But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

 

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With the government trying to make the third dose mandatory I'm suddenly sympathizing with the no-vaxxers and the conspiracy theorists.  Either I play the role of a guinea pig (since the health authorities clearly don't know what they are doing and all is now trial and error) or I'll be suspended from work without salary. There goes free choice and freedom. This is the new Western tyrannocracy.

My political inclinations are changing and I think my next vote will go to those opposing the mandatory vaccinations.

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18 hours ago, mccoy said:

With the government trying to make the third dose mandatory I'm suddenly sympathizing with the no-vaxxers and the conspiracy theorists. 

I see a silver lining.  The mandatory vaccine fever appears to be spreading fast.  In addition to Italy, Germany is also giving it serious consideration.  France, Spain and the UK have partial mandates in place and could easily expand to full mandates too.  Ties between Europe and South America are strong and with just a bit more luck Argentina, Brazil and Uruguay will follow Europe's lead.  2022 is shaping up to be our best shot ever for a FIFA World Cup!

https://summit.news/2021/11/09/german-newspaper-highlights-unusually-large-number-of-soccer-players-who-have-collapsed-recently/

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About increased cardio risks and MRNA vax ... here is the new CIRCULATION paper that's getttin' a lotta attn .... (Al, do you have the FULL PRINT ? Thx!!)

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Does the risk of a heart attack increase from 11% up to 25% 
Abstract 10712: Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning (8th November)

Measurement of multiple protein biomarkers, which generates a score predicting the 5 year risk (percentage chance) of a new Acute Coronary Syndrome

Score is based on changes from the norm of multiple protein biomarkers, IL-16, (a proinflammatory cytokine) 

[etc... see video Description for more...]
 

https://www.ahajournals.org/doi/10.1161/circ.144.suppl_1.10712

 

 

 

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On 2/19/2022 at 10:06 PM, KHashmi316 said:

mRNA vaccines elevate myocarditis risk

This is something I looked into. Just to clarify, myocarditis after vaccination is extremely rare. But more importantly myocarditis from getting covid unvaccinated is likely far higher than getting myocarditis from the vaccine (despite also being rare) . So you could logically argue that the vaccine is actually PREVENTING more cases of myocarditis than it causes. 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm

 

 

 

 

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On 8/29/2021 at 7:59 PM, Dean Pomerleau said:

No, the study and the Lancet preprint about it are fine. It simply shows what we already know, namely that it is possible to get infected with Delta even if you are vaccinated, such breakthrough delta infections are most often mild and infections with Delta result in a much higher viral load in the nasal cavity than previous variants whether you are vaccinated or not.

The obvious nonsense was the article you posted about the study, which falsely claims that breakthrough infections had a higher viral load in vaccinated people than infections in non-vaccinated people and bogusly suggests that the high viral load in vaccinated people was due to the vaccine and not the fact that the comparison in the study was done between recent breakthrough infections with Delta in vaccinated individuals and people who were infected last year with the original variant (when vaccines weren't available) which produced a much lower viral load.

What this shows is that there are a lot of bamboozled and/or duplicitous anti-vax folks who can't or won't read scientific studies carefully enough to understand and/or honestly convey their findings but instead misconstrue them in articles and posts on the internet to serve their anti-vax agenda. This fact is also something that has become abundantly clear.

--Dean

I was vaccinated w/ both pfizer shots in June 2021; got Delta in January 2022. Had fever (not radically high, around 100.1) for 2 days, cold chills, body aches (literally everything hurt), then was fatigued for 3-4 days; followed by loss of taste/smell for 1 month. Now feel totally fine.

What I really noticed during height of covid (fever) was that my appetite was still really good, so I just slammed a bunch of indian food, pizza, sushi, etc. Compared to influenza (which I have been sick w/ 2-3 times in my life), covid seemed like a virus that was 30% of the capacity of the flu.

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On 2/23/2022 at 2:04 PM, Gordo said:

This is something I looked into. Just to clarify, myocarditis after vaccination is extremely rare. But more importantly myocarditis from getting covid unvaccinated is likely far higher than getting myocarditis from the vaccine (despite also being rare) . So you could logically argue that the vaccine is actually PREVENTING more cases of myocarditis than it causes. 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm

 

 

 

 

Yes the actual virus will have a higher likelihood of impacting your circulatory system (and importantly, heart) than the vaccine. There is much that is unknown about covid (still), and it is totally unclear why some people develop blood clots and heart problems after having the virus, while others may show no symptoms (during infection) and after infection. 

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Safe and effective?  Maybe not...

Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials

Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase 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 absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).

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Another concern is how trustworthy are the published results for some vaccines.  

Apologies to those who do not have access to the source on The Economist website.  This a report on an article published on June 20th in the American Journal of Therapeutics

Are the Russian covid-vaccine results accurate?

If you flip a coin, your chances of getting heads or tails are equal. But if several people flip a dozen times each, the chance of them all getting a 50:50 split is small. Neither are they likely all to get exactly the same split, 50:50 or otherwise, between heads and tails.

[This concept shows] that clinical trial results for Russia’s Sputnik V covid-19 vaccine, published in the Lancet in 2021, contain some numbers which are extremely unlikely to occur in that type of trial.  Dr Sheldrick’s team examined what happens when various combinations of statistical noise occurred in a hypothetical sample of trial participants constructed according to the methods described in the Sputnik V paper. They used computer simulation to create 1,000 random variations of noise and counted in how many of these the vaccine efficacy resulting in each of the five age groups fell within the range reported by the Russian scientists.  For Sputnik V only 13 of 50,000 iterations fell in the reported ranges.  For the four comparison vaccines (AstraZeneca, Johnson & Johnson, Moderna and Pfizer), that result would be obtained in two of four repetitions.

These results thus call into question the efficacy numbers reported in the original Sputnik V paper. For its part, the Lancet said it recognised the concerns about the validity of the data and would be inviting the authors of the paper “to respond to these latest questions”.

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Getting endless boosters might be a poor strategy if these shots do more harm than good.  Note these results are from the original trial data when covid was more severe and before it was recognized how rapidly vaccine efficacy would fade.  One might also consider the trial results might have been worse if designed and conducted by independent 3rd parties without conflicts of interest.

 

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

Using a prespecified list of AESI identified by the Brighton Collaboration, higher risk of serious AESI was observed in the mRNA COVID-19 vaccine group relative to placebo in both the Pfizer and Moderna adult phase III trials, with 10.1 (Pfizer) and 15.1 (Moderna) additional events for every 10,000 individuals vaccinated. Combined, there was a risk difference of 12.5 serious AESIs per 10,000 individuals vaccinated (95 % CI 2.1 to 22.9). These results raise concerns that mRNA vaccines are associated with more harm than initially estimated at the time of emergency authorization. In addition, our analysis identified a 36 % higher risk of serious adverse events in vaccinated participants in the Pfizer trial: 18.0 additional SAEs per 10,000 vaccinated (95 % CI 1.2 to 34.9). Consistent with the FDA evaluation, our analysis found no clear difference in SAEs between groups in the Moderna trial.

Results between the Pfizer and Moderna trials were similar for the AESI analysis but exhibited substantial variation in the SAE analysis. Caution is needed in interpreting this variation as it may be substantially explained by differences in SAE recording practices in the trials rather than differences in actual vaccine harm profiles. For reasons that are not documented in the trial protocol, Moderna included efficacy outcomes in its SAE tabulations, while Pfizer excluded them. As a result, Moderna’s SAE table did not present a traditional SAE analysis but rather an all-cause SAE analysis. The FDA analysis of the Moderna trial presented an all-cause SAE analysis, which estimates total vaccine effects on SAEs, including effects transmitted via effects on COVID-19. It did not however present a traditional SAE analysis with efficacy endpoints removed, which attempts to estimate only the direct effects on SAEs. While our analysis attempted to perform a traditional SAE analysis by excluding efficacy SAEs (serious COVID-19 and its sequelae), our effort was hindered because we did not have access to patient level data. Easily recognizable efficacy SAEs (“COVID-19”, “COVID-19 pneumonia,” and “SARS-CoV-2 test positive”) could be removed, but many participants who experienced a COVID-19 SAE likely experienced multiple other SAEs (e.g. pneumonia, hypoxia, and thrombotic events) which could not be identified and therefore remain included in our analysis. Of 17 total efficacy SAEs (16 “COVID-19” and 1 “COVID-19 pneumonia”) removed from our analysis of the Moderna trial, 16 were in the placebo arm. As a consequence, the background SAE risk (risk in absence of COVID-19) would be overestimated by the Moderna placebo group, resulting in underestimation of the actual risk of SAEs and AESIs attributable to the vaccine in the Moderna comparisons as well as in the combined analysis. Access to patient-level data would allow adjustments for this problem.

Rational policy formation should consider potential harms alongside potential benefits. [29] To illustrate this need in the present context, we conducted a simple harm-benefit comparison using the trial data comparing excess risk of serious AESI against reductions in COVID-19 hospitalization. We found excess risk of serious AESIs to exceed the reduction in COVID-19 hospitalizations in both Pfizer and Moderna trials.

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I expect this is merely the first leak in what will soon become a deluge from countries around the world.  Anyone want to start a betting pool predicting the date Pfizer is sued out of existence? 

Serious Vaccine Side-Effects Covered Up by Israeli Government, Leaked Video Reveals

 

 

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When the official report came out, it compared the number of reports to the total number of vaccines given out since the beginning of the vaccination campaign. It did not mention that the adverse event reports came only from this small HMO. Furthermore, only people receiving vaccination after December 9th 2021 were likely to report to the system (though others could and did). But only about 10% of all vaccines given out in Israel were given out during the period of the study. Finally, when it reported on the menstrual adverse events, it compared them to the number of vaccines given to both women and men. All of these manipulations made the rate of reported events appear much smaller. And if all of this wasn’t enough, reports of events that resulted in or involved hospitalisation were not part of the analyses, as those were dealt with by a different team.

The researchers can also be heard in the meeting asking to get a meeting or have the results conveyed to Dr. Sharon Alroy-Preis, Head of Public Health Services at the Ministry of Health.

And as if all this wasn’t damning enough, Prof. Berkowitz says, in reference to the long-lasting side effects:

Here we will need to think about this medico-legally. Why? Because for not a few side-effects, we said “OK, it exists and there’s a report, but please get vaccinated”. So we need to think about how to write it and present it in the correct way, so they won’t come afterwards with lawsuits: “Wait a second, you said it would go away and it’s OK to get vaccinated, now look what happened to me.”

 

 

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