Originally Posted by
Flying Binghi
Lets pull a few quotes from that article:
Seems I were wrong with me 8 to 10 years approval time frame.. Oh well, can’t be right all the time..
This isn’t cutting corners. Rather, it’s an extensive standard review process that is expedited, he said.
“The standards could never be compromised even under an emergency authorization use of the vaccines; the data integrity is there and the safety of the participants is paramount,”
Burton pointed out that in the fall of 2020, the Moderna, Pfizer-BioNTech, and Johnson & Johnson vaccine trials all paused due to a safety signal.
“[The] truth is, that is part of the clinical trial process… we have people watching for any sign or symptom from the individuals that are in the trial, and the fact is that when we see something that meets the criteria, we [pause] the study… It’s integral to the design of every single study and shows that the process is working,” she said.
At one point in the trial the use was halted due a concern, the concern was addressed and the trial resumed. This is exactly how it’s meant to be.
“The reason that there is not a full licensure given to the vaccines is essentially because we have very limited time in understanding… the mid-term and long-term benefits of the vaccine in the individuals that were vaccinated
The key word is benefits. They know from the trials the vaccine is safe. But the long term efficiency over a large scale was partially unknown. The early indications were it would be effective at reducing severe disease. So it was assessed as safe and probably effective enough to put into mass production. And it worked.