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Suspected COVID in (Moderna and Pfizer) Vaccine Trials Was Not Counted

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Warning. Here's some alarming news about the Caucasian crap vaccine based on dangerous and unproven mRna technology. It's a death trap. That 95% effectiveness data is a LIE based on heavily manipulated data. The actual effectiveness rate is between 19% (realistic) to 29% (optimistic).

This study is supported by real world data. See bottom of page.



Suspected COVID in Vaccine Trials Was Not Counted

January 11, 2021

Writing in The BMJ (British Medical Journal) Opinion blog, associate editor Peter Doshi calls for more information and details from the raw data that the two current COVID-19 vaccine makers, Moderna and Pfizer, did not report. Homing in on what the drug companies classified as “suspected COVID” but not counted because they were not PCR test-confirmed, Doshi says: “With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test...

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Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data

January 4, 2021




Five weeks ago, when I raised questions about the results of Pfizer’s and Moderna’s covid-19 vaccine trials, all that was in the public domain were the study protocols and a few press releases. Today, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of each company’s mRNA vaccine. While some of the additional details are reassuring, some are not. Here I outline new concerns about the trustworthiness and meaningfulness of the reported efficacy results.


“Suspected covid-19”


All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected covid-19”—those with symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”


With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).



If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may be due to a different causative agent.


But why should etiology matter? If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.


However, if confirmed covid-19 is on average more severe than suspected covid-19, we must still keep in mind that at the end of the day, it is not average clinical severity that matters, it’s the incidence of severe disease that affects hospital admissions. With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.


There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected covid-19” cases. Nor did its publication in the New England Journal of Medicine. Nor did any of the reports on Moderna’s vaccine. The only source that appears to have reported it is FDA’s review of Pfizer’s vaccine.


The 371 individuals excluded from Pfizer vaccine efficacy analysis


Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)


What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group? The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.


Fever and pain medications, unblinding, and primary event adjudication committees



Last month I expressed concern about the potential confounding role of pain and fever medications to treat symptoms. I posited that such drugs could mask symptoms, leading to underdetection of covid-19 cases, possibly in greater numbers in people who received the vaccine in an effort to prevent or treat adverse events. However, it seems their potential to confound results was fairly limited: although the results indicate that these medicines were taken around 3–4 times more often in vaccine versus placebo recipients (at least for Pfizer’s vaccine—Moderna did not report as clearly), their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidence curves suggest a fairly constant rate of confirmed covid-19 cases over time, with symptom onset dates extending well beyond a week after dosing.


That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in. The primary endpoint in the trials is relatively subjective making unblinding an important concern. Yet neither FDA nor the companies seem to have formally probed the reliability of the blinding procedure, and its effects on the reported outcomes.


Nor do we know enough about the processes of the primary event adjudication committees that counted covid-19 cases. Were they blinded to antibody data and information on patients’ symptoms in the first week after vaccination? What criteria did they employ, and why, with a primary event consisting of a patient-reported outcome (covid-19 symptoms) and PCR test result, was such a committee even necessary? It’s also important to understand who was on these committees. While Moderna has named its four-member adjudication committee—all university-affiliated physicians—Pfizer’s protocol says three Pfizer employees did the work. Yes, Pfizer staff members.


Vaccine efficacy in people who already had covid?


Individuals with a known history of SARS-CoV-2 infection or previous diagnosis of Covid-19 were excluded from Moderna’s and Pfizer’s trials. But still 1125 (3.0%) and 675 (2.2%) of participants in Pfizer’s and Moderna’s trials, respectively, were deemed to be positive for SARS-CoV-2 at baseline.


Vaccine safety and efficacy in these recipients has not received much attention, but as increasingly large portions of many countries’ populations may be “post-Covid,” these data seem important—and all the more so as the US CDC recommends offering vaccine “regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.” This follows on from the agency’s conclusions, regarding Pfizer’s vaccine, that it had ≥92% efficacy and “no specific safety concerns” in people with previous SARS-CoV-2 infection.


By my count, Pfizer apparently reported 8 cases of confirmed, symptomatic Covid-19 in people positive for SARS-CoV-2 at baseline (1 in the vaccine group, 7 in the placebo group, using the differences between Tables 9 and 10) and Moderna, 1 case (placebo group; Table 12).


But with only around four to 31 reinfections documented globally, how, in trials of tens of thousands, with median follow-up of two months, could there be nine confirmed covid-19 cases among those with SARS-CoV-2 infection at baseline? Is this representative of meaningful vaccine efficacy, as CDC seems to have endorsed? Or could it be something else, like prevention of covid-19 symptoms, possibly by the vaccine or by the use of medicines which suppress symptoms, and nothing to do with reinfection?


We need the raw data


Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.


Pfizer says it is making data available “upon request, and subject to review.” This stops far short of making data publicly available, but at least leaves the door open. How open is unclear, since the study protocol says Pfizer will only start making data available 24 months after study completion.


Moderna’s data sharing statement states data “may be available upon request once the trial is complete.” This translates to sometime in mid-to-late 2022, as follow-up is planned for 2 years.


Things may be no different for the Oxford/AstraZeneca vaccine which has pledged patient-level data “when the trial is complete.” And the ClinicalTrials.gov entry for the Russian Sputnik V vaccine says there are no plans to share individual participant data.


The European Medicines Agency and Health Canada, however, may share data for any authorized vaccines much earlier. EMA has already pledged to publish the data submitted by Pfizer on its website “in due course,” as has Health Canada.


Peter Doshi, associate editor, The BMJ


Competing interests: I have been pursuing the public release of vaccine trial protocols, and have co-signed open letters calling for independence and transparency in covid-19 vaccine related decision making.



Footnote


Calculations in this article are as follows: 19% = 1 – (8+1594)/(162+1816); 29% = 1 – (8 + 1594 – 409)/(162 + 1816 – 287). I ignored denominators as they are similar between groups.

Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data - The BMJ


As things stand at the moment, it is hard to deny the possibility of a correlation between mass vaccination and a sharp spike in Covid-19 cases in both Israel and Britain. It is hard to deny the fact that Israeli Arabs who at large avoid the vaccine are doing far better than the Jewish orthodox who seem to also believe in Pfizer.


 
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Oracle

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They banned tweets for anti vaccines and false data.

And people with zero knowledge have started blogs
Don't know how they camw up with 19% success rate
 

Mista

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They banned tweets for anti vaccines and false data.

And people with zero knowledge have started blogs
Don't know how they camw up with 19% success rate
By pulling out of their arse, of course.


 

khansaheeb

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13 Israelis suffer FACIAL PARALYSIS after taking Pfizer Covid jab, amid influx of reports detailing adverse effects
16 Jan, 2021 14:52
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13 Israelis suffer FACIAL PARALYSIS after taking Pfizer Covid jab, amid influx of reports detailing adverse effects

A medical worker prepares to administer a vaccine injection in Tel Aviv, Israel January 10, 2021 © REUTERS/ Ronen Zvulun
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At least 13 Israelis have experienced facial paralysis after being administered the Pfizer Covid-19 vaccine, a month after the US Food and Drug Administration reported similar issues but said they weren’t linked to the jab.
Israel has been hailed for its speedy and efficient mass inoculation program, which has vaccinated a staggering 20 percent of the country’s population since the drive began at the end of December.
For a handful of Israelis, however, the initiative has led to some unexpected health scares. At least 13 people have reported mild facial paralysis after receiving the Pfizer/BioNTech jab, Israeli outlet Ynet reported, citing the Health Ministry, adding that officials believe the number of such cases could be higher.
“For at least 28 hours I walked around with it [facial paralysis],” one person who had the side effect told Ynet. “I can't say it was completely gone afterwards, but other than that I had no other pains, except a minor pain where the injection was, but there was nothing beyond that.”
ALSO ON RT.COM4 volunteers develop FACIAL PARALYSIS after taking Pfizer Covid-19 jab, prompting FDA to recommend ‘surveillance for cases’
The unnamed individual noted, though, that the unpleasant reaction was “something rare” and stressed that it was “important” people get vaccinated. However, he conceded that he was undecided about receiving a second dose of the vaccine.
Israel’s Health Ministry has stated that it is safe to administer the second shot, provided the facial paralysis passes and there are no lingering, long-term effects from the first jab. But some Israeli medical experts have chosen to ignore this advisory.
Ynet quoted Prof. Galia Rahav, director of the Infectious Diseases Unit at Sheba Medical Center, who said she did not feel “comfortable” with administering the second dose to someone who had received the first jab and subsequently suffered from paralysis.
“No one knows if this is connected to the vaccine or not. That's why I would refrain from giving a second dose to someone who suffered from paralysis after the first dose,” she told the outlet.
Last month the FDA disclosed that Bell’s palsy, a form of temporary facial paralysis, was reported by four participants during phase three trials of the Pfizer vaccine. All four cases involved individuals who had been given the actual jab. There were no reports of paralysis among the control group that received a placebo.
In its report, the FDA noted the “numerical imbalance” of Bell’s palsy cases among the vaccine and placebo groups, but it said there were no other “non-serious adverse events” that showed a similar pattern.
Ultimately, the US drug regulator concluded that the issue was “consistent with the expected background rate in the general population,” and added that there was no clear evidence linking the coronavirus vaccine to the unpleasant medical condition. Still, the agency recommended“surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations.”
ALSO ON RT.COM‘We see nothing alarming,’ says Norwegian drugs regulator, after 13 deaths linked to Pfizer vaccine jabs
Over the past several weeks, the Pfizer drug has received emergency approval from governments scrambling to vaccinate their citizens. In December, the UK became the first country in the world to begin administering the jab to the general population. Although health officials have described the vaccine as safe and effective at reducing Covid-19 symptoms, worrying reports continue to surface about serious adverse effects. Mexico launched a probe in early January after a young doctor was left paralyzed minutes after being administered the drug. There have also been numerous cases in which people who suffer from allergies have experienced severe reactions to the shot.
Several reports have also linked the jab to unexplained deaths, but authorities have insisted that there is no evidence to suggest the vaccine is to blame in such cases. For example, a Portugese doctor who was reportedly in “perfect health”died shortly after being given the jab, but officials later concluded that there was no relationship between the death and the vaccine, adding that they could not disclose the exact cause of her death for legal reasons.
 

TaiShang

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I will wait at least few years till all the side effects of this new application is clarified.

Luckily, as I Taiwan resident, I have access to Mainland vaccine. Free of charge.
 

Menthol

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The most surprising is how can there be no report on side effects during the third trial?

It's after it has been approved and started mass vaccination, all the problems occurred.


The western brand than to be trustful compare with Chinese brand because of Western countries has stricter regulation.

But to be honest, in this mRNA vaccine case, those regulations don't work because of the emergency situation.


So basically, in this case, the brand alone will not guarantee 100% safety.

To be honest, in my opinion, it's problematic.

But quite effective in the eyes of politicians in terms of politics and economy.
 

52051

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The most surprising is how can there be no report on side effects during the third trial?

It's after it has been approved and started mass vaccination, all the problems occurred.


The western brand than to be trustful compare with Chinese brand because of Western countries has stricter regulation.

But to be honest, in this mRNA vaccine case, those regulations don't work because of the emergency situation.


So basically, in this case, the brand alone will not guarantee 100% safety.

To be honest, in my opinion, it's problematic.

But quite effective in the eyes of politicians in terms of politics and economy.
The west media is much "stricter" towards Chinese vaccines, but after 14 million shots of Chinese vaccines world-wide now, so far the only negative news the west media/brainwashing machine can dig about Chinese vaccines is the so-called "low efficiency", which itself is computed by typical west interception about the trail results and test method.

So we can say its pretty safe to say the Chinese vaccines are VASTLY superior to the death traps from the West.
 

Menthol

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The west media is much "stricter" towards Chinese vaccines, but after 14 million shots of Chinese vaccines world-wide now, so far the only negative news the west media/brainwashing machine can dig about Chinese vaccines is the so-called "low efficiency", which itself is computed by typical west interception about the trail results and test method.

So we can say its pretty safe to say the Chinese vaccines are VASTLY superior to the death traps from the West.
Western governments think this is a game of geopolitical rivalry.

It's suicidal.

They injected almost all of their own people with the questionable vaccine, just to win the geopolitical race with China.
 

Han Patriot

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Western governments think this is a game of geopolitical rivalry.

It's suicidal.

They injected almost all of their own people with the questionable vaccine, just to win the geopolitical race with China.
Don't forget the Brazilian president is trying to sabotage Chinese vaccine, they intentionally injected infected people with the Sinovac vaccine. Look at how mild CNN is treating Pfitzer even with a few dozen deaths. If it was Chinese, we would have been grilled alive.
 

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