- Jul 28, 2021
Did the vaccine work? YesFor the 100th time, it's not the pressure to cut red tape in clinical development and manuafacturing, to allow rapid development of vaccines, that anyone is complaining about.
That is, in fact, laudable.
It's the pressure to skip steps regarding clinical data requirements necessary for approval, either EUA or fill approval, that is not acceptable. To skip steps to gain votes is abhorrent.
The scientists set the bar for data (>2 months of safety data for EUA, >12 months of full approval) based upon a long track record of safety data for other drugs and other vaccines.
It would not be acceptable, for example, for Biden to force the FDA to grant full approval tight now, even though that might convince more people to get vaccinated. 12 months of data is not in hand. It will be by the end of August, when you can expect the Pfizer vaccine to be fully approved. Biden has no say in that, nor should he.
Did any of your quoted steps get broken? No
So where is the proof he tried to break those rules? I think that proof was what the rumors were referring too… you speak as if it is fact that he was trying to circumvent protocols in place to protect people and that just isn’t true. I’m sorry but it’s not. Anonymous sources are not proof… nor are rumors