Tag Archives: clinical trials

Shouldn’t They Have Done This First?

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On Sunday, The Conservative Review reported:

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Dec. 11, 2020. A week later, the FDA issued an EUA for Moderna’s COVID-19 vaccine. Now, nearly two years later, Pfizer and Moderna will launch clinical trials to track adverse health issues stemming from the COVID-19 vaccines, such as myocarditis – inflammation of the heart muscle.

Pfizer is in the infancy of beginning clinical trials to determine if there are any health risks associated with their own vaccine. In a partnership with the Pediatric Heart Network, the trial will focus on vaccine recipients who have suffered heart issues following being jabbed with the COVID-19 vaccine. The clinical trials will monitor patients for five years.

Enrollment for the study in the U.S. and Canada has not started yet. However, the research team has already identified more than 250 patients with myocarditis, according to Dr. Dongngan Truong – a pediatrician at the University of Utah Health and a co-lead on the Pfizer study.

NBC News reported on Friday, “The team will also compare the patients to a subset of patients with multisystem inflammatory syndrome in children, also known as MIS-C, which is associated with a COVID infection.”

The article concludes:

In July 2021, the Centers for Disease Control and Prevention (CDC) released a report that stated: “An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 12–29 years.”

The report found, “Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 12−29 years.”

The CDC added, “Myocarditis and pericarditis have rarely been reported. When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna).”

In April, an Israeli large-population study of 196,992 unvaccinated adults who were post-COVID-19 infection were “not associated with either myocarditis or pericarditis.”

“We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection,” the authors wrote.

I believe that the federal government wants to include the Covid vaccine in its list of vaccines required for children to attend school. Until this study is completed, that is not a good idea.

The Dog Ate My Homework

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Yesterday The Conservative Treehouse posted an article with the following headline:

What!?

The article reports:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

(Via NPR) […] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots. (read more)

The article notes:

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed.

Whiskey – Tango – Foxtrot !!!  This is nuts.

That NPR article is one to bookmark when people start claiming the vaccination is effective.

How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?

Somehow I don’t believe this fits the requirement of “follow the science.” Please follow the link to read the entire article. We are definitely being played.