The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies and local governments to make vaccinations mandatory.
The Pentagon promptly announced it will press ahead with plans to require members of the military to get vaccinated amid the battle against the extra-contagious delta variant. Louisiana State University likewise said it will demand its students get the shot.
All this means is that the people refusing because the vaccine was experimental or was authorized under emergency use provisions have lost their basis for refusal. More and more schools and employers will mandate getting the vaccine, or quitting. For those in the service, it will be get the vaccine or take an OTH discharge.
I am sure you've read the relevant documents from the FDA on their approval of the use of the Pfizer vaccine, as they are freely posted. How do you square the drive to have everyone take this when the approval does not meet normal Federal standards for medical approval, and is all according to emergency use authorizations that hold the manufacturer and government harmless?
ReplyDeleteSearch for the following on the document: https://www.fda.gov/media/150386/download
Pg 12 - This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
and (Pg 7 / 8) - The emergency use of Pfizer-BioNTech COVID‑19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and Page 8 – Pfizer Inc. under the circumstances set forth in the Secretary of HHS’s determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), Pfizer-BioNTech COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 12 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal
law.
This says to me, "We can tell you what to do, because we say we can, not because we're following the science that we would normally follow." Very not cool with me. My body, my choice comes to mind.
The same people who said they didn't trust an "experimental" vaccine will tell you that giving it full approval is a conspiracy plot.
ReplyDeleteI'll be so happy when the have an approved vaccine for children; then the conspiranoids can get as sick as they want.
When TFG was campaigning he was pushing for an approval of the vaccine to give himself a win and something to crow about and his supporters were cheering. Reading the comment section of the area newspaper the MAGATs are already saying the FDA pushed it through too fast. Some of these people are broken and you just can't fix them no matter how hard you try.
ReplyDeleteThere's' a toon of a character surrounded by flames and saying, "I'm worried about the long term effects of fire extinguishers". Yep, your choice, affecting your life and everyone else's.
ReplyDeleteGromit, the EA is no longer relevant. If you want to risk staying unvaccinated and spreading COVID, then you’re making a choice for those around you who cannot get vaccinated because of their age and immune status. Whatever else you do, don’t take any horse pills.
ReplyDeleteClassic!
ReplyDeleteThe Experimental use was the original and now dated statement.
The act of using old facts now invalid is a form of news being
faked. Its an attempt to ignore the fact that its approved for
use and not under any exception.
One might then use that as a way to justify the lie of "rushed to
use and approval". However it ignores the fact that at things point
it has a better safety record of the original polio vaccine (salk)
the injection that needed to be done 3 times at one month spacing!.
The later Sabin was oral and one dose.
I think its an application of shading the truth. Shining a light
elsewhere and calling that the truth while casting a shade on the
real, complex, and more current truth.
Eck!
In a demonstration of the dangerous nature of propaganda, Fergus, the "Operation Warp Speed" guy, was booed at one of his rallies for encouraging rallygoers to get vaccinated.
ReplyDelete-Doug in Sugar Pine