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by Madhava Setty, M.D., Childrens Health Defense:

The Canadian COVID Care Alliance assembled a presentation that demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have definitively answered questions about the vaccine’s safety and efficacy.

The disagreements around whether COVID-19 vaccinations are “safe and effective” stem not only from the subjective nature of such descriptors but also from the lack of consensus around the data used to substantiate or refute such a claim.

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The Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Reports (MMWR) often draw from limited observations, and their assessment of vaccine effectiveness is based on relatively small subsets of our population.

Their conclusions are sometimes reflective of outdated data and conflict with their own recommendations.

For example, here the CDC’s latest estimation of vaccine effectiveness is upwards of 80% in preventing COVID-19 (i.e. the risk of becoming infected is 5 times less if vaccinated). Why then the recommendation for boosters?

Note that this latest metric is based on the CDC’s most recent data from more than one month ago and represents data drawn only from 27 jurisdictions.

Eric Topol, a professor of molecular medicine at Scripps Research, is a former advisory board member of the Covid Tracking Project, a team that worked to collect and synthesize local COVID-19 during the peak of the pandemic.

Politico recently quoted Topol:

“I think we’ve done a horrible job from day one in data tracking for the pandemic. We’re not tracking all the things that we need to to get a handle on what’s going on. It is embarrassing.”

Meanwhile, vaccine injuries continue to accumulate in the Vaccine Adverse Event Reporting System (VAERS) and go unacknowledged, making any constructive discussion around risk impossible.

In order to find common ground, it is perhaps most appropriate to focus on published data from the vaccine trials themselves.

Was Emergency Use Authorization justified? Was the current confusion around vaccine effectiveness and safety predictable from the beginning?

A presentation by the Canadian COVID Care Alliance

Canadian COVID Care Alliance (CCCA) is a group of “Independent Canadian doctors, scientists and healthcare professionals committed to providing top quality and balanced evidence-based information to the Canadian public about COVID-19 so that hospitalizations can be reduced, lives saved and our country restored as safely as possible.”

CCCA assembled a presentation that comprehensively demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have answered the safety and efficacy questions definitively.

In this concise slide deck with an explanatory video, CCCA powerfully summarized why Pfizer’s trial was not designed to adequately demonstrate its product’s safety and efficacy.

Here are a few key points from the CCCA presentation:

  • Initial data demonstrated a high relative risk reduction of infection yet this amounted to an absolute risk reduction of only 0.84%. It is the absolute risk reduction that determines the risk-benefit ratio required to make informed decisions around inoculation.
  • Early unblinding: Several months before publishing six-month observational results Pfizer opted to offer its product to those participants who received the placebo. By eliminating nearly all participants in the placebo wing Pfizer effectively closed the curtain on its experiment because long-term comparisons can no longer be made.
  • All-cause mortality and morbidity, the only sensible outcomes to use in determining efficacy and risk, were not considered. Indeed, all-cause mortality was higher in the vaccinated group after six months.
  • Severe adverse events outnumbered cases of severe COVID prevented after six months of observation.
  • Trial participants were not reflective of the most vulnerable members of our population — more than 50% of people dying from COVID are 75 years of age or older. This age group made up only 4.4% of trial participants. Also, 95% of those who have died from COVID had one or more comorbidities. Nearly 80% of trial participants had none.
  • Not every trial participant was tested for COVID. Asymptomatic or paucisymptomatic (presenting few symptoms) cases were missed.

Questions regarding unblinding and data integrity

The CCCA presentation also resurrects a puzzling observation mentioned in a briefing document Pfizer submitted only to the FDA’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA, but nowhere else — including the widely cited summary of the trial reported in New England Journal of Medicine.

Read More @ ChildrensHealthDefense.org


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