November 26, 2021

Vaccines Approved Based On Statistical Analysis Which Would Fail 'Statistics 101'

James Doogue

When the new Covid-19 vaccines were approved by health authorities around the world, (e.g. FDA in the US, TGA in Australia), we were excitedly told the vaccines, mostly with two doses, had an efficacy rate of between 90% and 95%.

They admitted they didn't know how long 'immunity' lasted, but thought it possible there may need to be a booster after say 12 months, and perhaps every 12 months.

It's important to understand the definition of 'efficacy'. It is the rate at which the disease is blocked in the vaccinated group, compared to the unvaccinated group, in a controlled study with randomised selection of subjects, and exclusion of any factors which may adversely influence the results.

In the simplest terms, for laypersons if 100% of unvaccinated subjects caught the disease and only 5% of vaccinated subjects, then the vaccines efficacy rate would be 95%. In their study, Pfizer says it recorded 170 covid-19 cases (in 44,000 volunteers), with a remarkable split: 162 in the placebo group versus just 8 in the vaccine group.

As I and many others pointed out given the studies were done over a period of months, not years, we couldn't rightly draw any sound conclusions from this data. Certainly not like what we were being told. Get vaccinated because it will prevent you from becoming infected and spreading the disease.

Importantly the study told us nothing about the vaccine’s ability to save lives, nor the ability to prevent infection over any decent period, nor the efficacy in important subgroups (e.g. frail elderly).

The results reflected a time point relatively soon after vaccination, and we knew nothing about vaccine performance at 3, 6, or 12 months, nor any medium or long term adverse effects.

Also missing from the group studied were children, pregnant women and a range of other subgroups.

Regardless, our politicians and health authorities were keen to launch mass vaccination programs having deliberately dismissed any other options including prophylaxis and treatments which were being used with reported success around the globe.

Anyone who suggested any combination of treatments such as vitamin D, zinc, hydroxychloroquine, chloroquine, antibiotics, ivermectin etc, were dismissed as quacks, anti-vaxers or worst.

It seemed at least in much of the world, it had been predetermined that mass vaccination was the only way out of the pandemic.

What we know now is that the efficacy of vaccines is significantly lower than 95% in the real world application. We now know that whatever the efficacy, it wanes very quickly, so that within 3 to 6 months immunity is on par with an unvaccinated person and a third shot is needed.

In fact it's worse than that, because in some of the most vaccinated places in the world, infection rates are spiking.

A study published Sept. 30, in the peer-reviewed European Journal of Epidemiology Vaccines found "no discernible relationship” between the percentage of population fully vaccinated and new COVID cases.

The study found the most fully vaccinated nations had the highest number of new COVID cases, based on the researchers’ analysis of emerging data during a seven-day period in September. https://link.springer.com/article/10.1007/s10654-021-00808-7

The authors said the sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences "needs to be re-examined,” especially considering the Delta (B.1.617.2) variant and the likelihood of future variants.

They wrote:

"Other pharmacological and non-pharmacological interventions may need to be put in place alongside increasing vaccination rates. Such course correction, especially with regards to the policy narrative, becomes paramount with emerging scientific evidence on real-world effectiveness of the vaccines.”

The ability for vaccines to keep people out of hospital, or from dying is questionable too. It's generally agreed that the Delta variant is more infectious, but less deadly, which might be the only reason why severe cases and death rates have fallen.

None of this would be a surprise, had we studied the published results of vaccine trials as closely as Peter Doshi as explained in the linked article. 'Pfizer and Moderna’s "95% effective” vaccines—we need more details and the raw data'. https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/

We were sent along this mass vaccination path which is at best, not working, and at worse, placing healthy people in unnecessary danger of adverse vaccine reactions. This occured through either incompetence, fraud, or as a pre-determined strategy, or some combination of the three.

Here are some key points raised by Doshi just about the Pfizer trials which should not have allowed them to claim a 95% efficacy rate:

- The reported 170 Covid-19 positive cases numbers in the Pfizer study 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. But it was for the purpose of calculating efficacy. Madness!

Had those numbers been included, the official efficacy rate for the Pfizer vaccine would have fallen below 50%.

- The Pfizer report should have done an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants, as it 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.'

- Another great concern regarding Pfizer's report on efficacy is also found not in their 93 page report, but the FDA's report - 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.

What if the vaccine participants were feeling ill, so took some medication? That would have placed them outside the trials 'controls', so they were dropped from the study. They may have actually had Covid-19.

'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.'

What Peter Doshi points out is that had the vaccine study results been more critically analysed by health authorities and made public by a critical media, the public would not have acquiesced to a mass vaccine mandate the way we have done.

Why were such amateurish vaccine study reports allowed to dictate the global response to the pandemic?

Posted by: Timothy Birdnow at 09:28 AM | Comments (4) | Add Comment
Post contains 1175 words, total size 8 kb.

1 Well, the bigger fail in reporting of the study is that it was unknown how many of the test subjects were exposed to the virus. You cannot possibly calculate efficacy when you do not know the degree of exposure. How many of those who were not infected were protected by the vaccine, and how many simply never came in contact with the virus? Idiots.

The only valid test for efficacy is to vaccinate one group and not the other, and then deliberately infect, positively and actively infect, both groups. Then compare the groups as to the number of subjects who were affected by the infection – that is, those who were made sick versus those who shrugged it off.

Obviously, this test is done on animals with immune systems similar to that of humans, and it has never been done for the coronavirus vaccine. They have no idea what the efficacy rate is, and are coming up with numbers my methods similar to voodoo doctors throwing bones.


Posted by: Bill H at November 26, 2021 09:43 AM (/sW5m)

2 Absolutely agree Bill. We can't produce proper numbers without knowing who is exposed or not. That is basic science.

Posted by: Timothy Birdnow at November 27, 2021 08:27 AM (1eXJd)

3 Bill has some good stuff here, but I think it's all basically a side issue, in the sense that governments' (not only ours) response to COVID has basically been political rather than scientific. I think that COVID is a companion to Climate Change in the quivers of governments the world around. In other words, it's not about COVID at all (and not about Climate Change either). It's all a big money transfer. "Follow the money" is as good advice now as it has always been.

Posted by: Dana Mathewson at November 27, 2021 11:31 PM (Ys0s/)

4 Ding! Ding! Ding!  We have a winner Dana!

Posted by: Timothy Birdnow at November 28, 2021 09:38 AM (uza+z)

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