Photo by Diana Polekhina on Unsplash
There is a dwindling group of people in the United States who will be among the last Americans still able to refuse to take the Pfizer BioNTech BNT-162b2 vaccine…
As the President asserts that he has the authority to mandate vaccines for just about everyone in the United States, there remains one stubborn group of people who are beyond his reach: the people who are still a part of the ongoing clinical trial for the Pfizer BioNTech vaccine. And as the linked protocol indicates, the study will not be completed until May 2023. Now, in case you didn’t know, the FDA has licensed one Pfizer vaccine called COMIRNATY… but it’s not available. The only one that’s available in the United States, the BioNTech BNT-162b2 (“BNT”), is still NOT an FDA-licensed vaccine. While it may be ‘approved’ for Emergency Use Authorization (EUA), BNT is absolutely not a “licensed product” under federal law.
So, here’s the Columbo moment that quite frankly I missed and so has every lawyer litigating this issue:
The study protocol linked above began just after the start of the pandemic – in April 2020. In order to have a Phase 3 clinical trial for BNT, Pfizer had to solicit volunteers. Let me pause and let that sink in for a moment. Pfizer, Inc. was not allowed to, for example, go out on the street and threaten to take away people’s jobs if they didn’t participate in the Phase 3 Clinical trial… which is still ongoing. They had to get every single subject’s VOLUNTARY, INFORMED CONSENT, in order to give them Pfizer BNT-162b2. Again, THAT CLINICAL TRIAL STILL HASN’T ENDED.
How can it be possible that at the same time that the Phase 3 clinical trial is still ongoing – and under Institutional Review Board (IRB) procedures requiring informed consent – that the same exact drug for the same exact indication, can be mandated for 100 million Americans?? Upon pain of losing your job? Of being given a court-martial and throw in jail? Of being deprived of all of your rights? Because you won’t give your consent to take that same exact (STILL) EXPERIMENTAL drug??
Under this upside-down world reading of the law, the 44,000 people in the BNT clinical trial – especially the ~22,000 who originally received the placebo (although they were later unblinded, dissolving the control group) – could be among the last people in the US who have the option to refuse that experimental shot. Is it really possible to force American citizens to take an experimental drug at the same time that people in the ongoing clinical trial had the right to refuse – i.e. had to be volunteers? If there is any question or ambiguity in the Emergency Use Authorization statute – and there shouldn’t be, the statute is plain on its face that EUA products cannot be mandated – but even if the FDA concocts some word-twisting justification, shouldn’t simple logic tell us that it can’t be possible to mandate a vaccine for huge swaths of the public when (a) the people who had to be recruited for the ongoing clinical trial had to be asked for their permission to join the study, and (b) the study still hasn’t finished.
And here’s the final puzzler for you, Dear Reader, perhaps hypothetical, perhaps not: if one of the people in the (now-unblinded) placebo group were a federal contractor, air traffic controller, or member of the military, could they simultaneously have refused to accept the vaccine – while still being part of the experiment – and yet somehow, simultaneously, with Schroedinger’s vaccine, be prosecuted and thrown in jail for refusing to take it as a condition of continued honorable service in the military?
…if this sounds ridiculous and impossible, I would encourage anyone to have a close look at the paperwork that the FDA requires be given to people being currently forced to take the shot. (Hint: there is a clause in there that shows that the ridiculous situation we are in is known to folks at both the military and FDA).
