(Headline USA) The U.S. gave full approval to Pfizer‘s COVID-19 vaccine on Monday, a milestone intended to help lift public confidence in the shots as the nation battles a contagious coronavirus mutant that shots don’t seem to be able to prevent.
The vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration. More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said acting FDA Commissioner Janet Woodcock. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
However, the agency took shortcuts to reach its decision of final approval, as related by ConservativeTreehouse.com based on reports from CNBC and NPR:
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.
The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said in a statement he hoped the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”
The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.
That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot still has emergency authorization for 12- to 15-year-olds.
Adapted from reporting by Associated Press.
