Roseanne Roseannadanna this ain’t. But the late great Gilda Radner might have said Simmer down now after the news from the FDA.
There has been a lot of discussion, debate and even some side bets made upon the approval by FDA for the Pfizer BLA of its Comirnaty vaccine. I have trouble pronouncing it.
This approval has created a lot of confusion whether or not the new biologic (vaccine) or what ever you want to call it, about its future. I refer to the new product as Cinderella.
Upon approval from the FDA, the airwaves, the social media posts, TV news reports, all speculating Cinderella will be under the jurisdiction of the NVICP for injury petitions seeking compensation.
The current program for all of the EUA (Emergency Use Authorization) products relating to the COVID epidemic belong to the CounterMeasures Injury Compensation Program (CICP), administered by HRSA.
Whether it is an injury or death as the result of a ventilator, medications, or the EUA biologics from Moderna, Pfizer or J&J, all claims must be submitted to HRSA under the guidance of The PREP Act and the CICP.
With the FDA approval of Pfizer’s Cinderella, the first step to transfer the biologic from the Black Hole of Hell (CICP) to the NVICP has begun.
The 1st step is ACIP approval of Cinderella to be routinely administered to children and pregnant mothers. Done. Poor or even the lack of science to support this approval.
But there are 2 remaining steps that need to accomplished. One of them might be very problematic.
The 2nd step is for Congress to approve a tax or levy upon Cinderella. The $0.75 current levy would be collected from monthly sales from Pfizer and the proceeds send to the Vaccine Injury Trust Fund. The $0.75 levy is a lie but I will reserve that issue for another time.
The 3rd step is the problem. The Secretary of HHS must announce Cinderella can attend the dance, publicize in the Federal Register so the town crier can announce to the entire public, then allow for public comment. This could take at a minimum of 6 months and maybe as long as 2 years. Will her ugly step sisters allow this to happen is doubtful at best.
Why would Pfizer allow experienced vaccine bar attorneys and medical experts to pick apart the science, clinical trial data or even FDA conclusions? This would happen with every petition filed in the NVICP.
In the CICP, petitioners do not have this luxury. Its you and the Sec’y of HHS. Guess who is going to win? Its not even a fair fight.
If Cinderella gets to attend the ball, I believe there will be no Prince looking for her, holding the little glass slipper.
So simmer down now, simmer down. Gilda, we miss you.
Keep learning, keep challenging yourself and always, always question authority.
Have a good day.