Fast Facts for May 7, 2021
Pfizer has submitted its formal request to the FDA to gain full regulatory approval of its Covid19 vaccine for Americans aged 16 and up.
Pfizer’s two dose vaccine was the first to be given Emergency Use Authorization by the FDA back in December and so far, the company has distributed more than 170 million vaccine doses in the United States.
So what’s the difference between emergency use authorization and full authorization by the FDA?
Not a lot. Just more data. Among many other things – and after the vaccine application is approved both the EUA and full vaccine approval require three-phase clinical trials with tens of thousands of participants to determine safety and efficacy. EUA requires two months of follow up data after the trial and full approval requires six months. Which Pfizer now has. That’s of course – in addition to manufacturing and chemical information and data proving the benefits outweigh any and all risks.
Pfizer will continue to provide “rolling data” to the FDA over the coming weeks and the company has requested “priority review” of its full approval application from the FDA.
It’s unclear if the FDA will allow the “priority review” but it certainly may because FDA Emergency Use Authorization for all Covid19 vaccines will expire “when the pandemic is over”. The full regulatory FDA approval could take months.
Explaining the FDA’s Emergency Use Authorization process here and here.
PLUS
A federal grand jury indicted all four former officers involved in the homicide of George Floyd on civil rights violations after a Justice department investigation.
Count one against Derek Chauvin says he took away George Floyd’s constitutional right “to be free from an unreasonable seizure, which includes the right to be free from the use of unreasonable force by a police officer” specifically because Chauvin knelt on Floyd’s neck and back for more than 9 minutes.
Count two indicts Tou Thao and J. Alexander Kueng on charges of violating Floyd’s constitutional right because they “willfully failed to intervene to stop defendant Chauvin’s use of unreasonable force.”
And count three indicts all four including Thomas Lane for violating Floyd’s constitutional right to due process of law and health concerns while in police custody because all of them “willfully failed to aid Floyd, thereby acting with deliberate indifference to a substantial risk of harm to Floyd.”
Before you ask – no. These charges have no impact on the state charges Thao, Lane and Kueng are still facing. And no this isn’t double jeopardy for Chauvin either. These are separate and different charges from the federal government which are allowed after a ruling by the supreme court.
Chauvin’s sentencing on the state murder charges is set for June 25. His lawyer has already filed an appeal seeking a new trial. The other three officers are expected to go to trial on the state charges in late August.
If convicted on these federal charges these men could be looking at additional prison time and penalties
Read the federal indictment here.
