With Pfizer Likely to Get FDA Approval Monday It’s Worth Remembering Pfizer and Moderna Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety
According to the New York Times and multiple media outlets, Pfizer is expected to get full FDA approval today. “The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.” With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:
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)
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. 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?
Good grief, the entire healthcare system is operating on a massive hive mindset where science, and the scientific method, is thrown out the window in favor of ideological outcomes and self-fulfilling prophecies. The fact that the researchers and doctors, apparently under the payroll of the pharmaceutical companies that have a vested financial interest in the vaccine outcome, lost the control group on purpose is alarming.
Of course, Big Pharma will promote the vaccine as beneficial, and the controlled media will promote that message with a complete disconnect from the clinical trial details, and the FDA will grant approval on results that were intentionally constructed to produce only one outcome.
As noted by Dr. Malone, the commonsense therapeutic approach should be the primary focus, not vaccination, for ongoing healthcare systems as the COVID-19 variants will continue to evolve. Ultimately, the natural immunity process will be of greater overall benefit than vaccinations which will require continual boosters to deal with the ever-evolving variants (a similar approach to dealing with reoccurring and evolving flu strains).
In essence, both Dr. Andrew Pollard (Director of the U.K. Oxford Vaccine Group), and Dr. Malone state that variants of the COVID-19 virus will continue to spread throughout the population regardless of vaccine status; and the virus will continue to evolve into more infectious but less deadly or pathogenic strains.
There simply is no way to vaccinate the population and stop the spread of COVID variants, because the vaccinated will contract and spread the virus just like the non-vaccinated. The vaccine approach should be targeted to the elderly and those most at risk.
Specific to the position of Dr. Malone – given the untested nature of the vaccine itself; no one knows the long-term side-effects; the benefit of the vaccine should be weighed against the individual’s current health status. Elderly populations with lower immune responses should be the target for vaccination; they are the most at risk. However, younger -less at risk- individuals will likely benefit more from therapeutic treatment after exposure *if* they experience any symptoms at all.
The problem is…. this commonsense approach is less favorable to the interests of the pharmaceutical industry and the healthcare systems that are controlled by the financial mechanisms inside the business of healthcare. Big Pharma would obviously make less money from a smaller target population for vaccination; ergo the therapeutic approach is a threat to the preferred approach of those who operate the business model. This is the overarching political battle.
The influence of the massive pharmaceutical corporations, inside the institutions of government controlled healthcare on a global basis, is massive. This outlook is the origin of the vaccinate push and vaccine narrative as the *only* and *best* solution. Anyone who raises a point, any point, in opposition to the mandated mass vaccine approach then becomes a target to be isolated, marginalized, ridiculed and removed.
Madness…. All of it.
- Source : The Last Refuge
