I am not a doctor. Do not take my OPINION as medical proof of anything. I am only presenting information from government and news resources. That being said, please consider the following.
The Food and Drug Administration posted the following press release – FDA Approves First COVID-19 Vaccine. Here is a quote…
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, 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, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
I think as a result of the FDA approval, several people will acquiesce and take the shot in full confidence that their health is assured. However, I have a concern after reading a NPR article published earlier this year.
Here are some quotes from the article. First the opening paragraph.
Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won’t be easily answered, because many people who had been in the placebo group have now opted to take the vaccine.
Further down in the article it reads…
Mott was one of about 650 volunteers who took the experimental Moderna vaccine at a company called Johnson County Clinical Trials in Lenexa, Kan. 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.
How can you perform a study of this type without a control group? And if you have no control group, how does it meet the “FDA’s rigorous, scientific standards for emergency use authorization?” Someone please explain this to me. I’ll wait.
