Pfizer Just Got ‘Full FDA Approval’ For Its COVID Vaccine. There’s Just One Thing…
Pfizer got full FDA approval yesterday.
“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:
[…] “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.
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. – READ MORE