Thursday, September 23, 2021

As IF Parameters for Usage of the 3rd Booster Shot Weren't Already Confusing Enough, the CDC Weighs In.


So, I was wondering, after the FDA approved the third shot - of exactly the same vaccine formulation as before, mind you - how they were going to stratify who worked in a "high-risk COVID exposure" environment or not?    

I mean, they'd have to be pretty specific, and I don't think they were - because if they leave it too vague and open, you could be like a dog-walker and say you're at increased risk, going into people's several people's homes or something lol.

And what about the immunocompromised, whether they work or not -  like people on immunosuppressants for organ transplants or cancer? 

The FDA completely ignored them unless they were 65 and older. 

So now, the CDC is about to weigh in and announce and publish its guidelines for use, and their advisory panel voted for the FDA's 65+ rule -  but against the FDA guideline of those 18 and older who work in environments with "high-risk exposure to COVID" - AND - they added those 50+ with particular health conditions (now including the immunocompromised.)

However, the panel was nearly split on that -  they can't even agree on that, because the scientific community is still grappling with the small population size that Pfizer used in its application study that did not prove the usual statistical significance required for approval.

So we're shooting in the dark, here, and doing a lot of presuming, about both the efficacy of a third shot and whether or not vaccine-induced immunity wanes over time. 

I mean, it's likely and it could, still - but there's a possibility it could not, too - because the study wasn't conclusive.

I'm not sure this has ever happened, where the CDC publishes guidelines separate from what the FDA approves, because that would mean the boosters were being given "off-label" to what the FDA authorized - and ultimately, the FDA has authority over the CDC, as executive branch, so-?

And what would that mean for payers, if the FDA hasn't authorized what the CDC recommends, because essentially we'd be using the product "off-label?"

I have no idea -  like I said, I don't think this has happened before?

Maybe it has and I don't know about it, but it's pretty rare. I mean, I'm sure it happens with some common, non-life-threatening conditions - like using an inexpensive product like steroids for rheumatoid arthritis or something - but I'm not sure it has ever happened with a really high-profile drug product in a life-threatening condition? 

So all righty, so get your popcorn - because IF the CDC does indeed end up publishing guidelines contrary to what the FDA authorized, they're essentially endorsing "off-label" usage of a product (meaning it's not authorized for use in this population/indication) -  it's about to get crazy up in here.

Because it would be testing the boundaries of which federal agency has authority over what (constitutionally, the FDA should win, as executive branch), as well as the American health system overall, that's for sure.

In fact, other countries have often based their coverage decisions on FDA approvals, so-?

I think they're making this too complicated again, even more than some states did with the vaccines and stratifying groups lol.

It's a nightmare for both providers and payers, even they won't know what the hell to do lol.

I mean, what if a doc gives the booster to someone whom the FDA does not consider an authorized use, but the CDC does - will they receive payment for it? And from whom?

Again, keep it simple  - most people have the attention span of gnats, these days, anyway.

Either approve it or don't.

If approved,   BE SPECIFIC, BUT ALSO DON'T OVER-STRATIFY - just stratify by like by age and health condition - period?!?

And dang, Pfizer - just work on a truly reformulated booster that includes all known variants and study it, already, rather than all this disruption and nonsense over a marginally effective third shot, at best, why don'tcha?

I mean, I'm sure you, and other Big Pharma,  would just love it if there was no regulatory authority at all, on your products, in America, but at least we are the most lenient Western country on you, so do you really want to pit it against itself and tear it down completely?

If so, I'm moving to France lol.

(Because IMO, they do the best job of keeping your greedy sh*t in check, Big Pharma lol. )

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