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Friday, September 24, 2021

CDC Chief Overrules Its Advisory Panel and Sticks With the FDA Authorization; the NEJM Publishes Studies Proving Moderna's Longer Effectiveness

 

(Edited)


The CDC's Chief, Dr. Rachel Walensky, has announced the CDC overruled its own advisory panel (ACIP) and stuck with the FDA's label for authorized use for their public-policy guidelines. 


As stated below, this was not the best choice, but likely the wisest choice.

I say the wisest choice because it avoids even more provider and payer confusion than there already is, because otherwise they'd be risking administering the vaccine potentially "off label" - not to mention avoiding a constitutional legal war with the FDA over who truly has authority over the new products.

That is a war which the FDA constitutionally should win, being executive branch, and the CDC knows it, even if they disagree.


The FDA has the authority to actually approve drugs and creates the authorized-usage label.

The CDC comes into play afterwards, creating usage guidelines for providers, as well as create public-health protective-precaution guidelines -  especially for public-health inoculation.  


However, this was not the wisest choice for public health overall, it's too confusing - but this time, that's the FDA's fault, not the CDC's.

Because what the CDC's advisory panel was trying to do was fill in the gaps left by the FDA in their authorization label - because they left off the specifics of certain at-risk subpopulations (certain immunosuppressed groups or other health conditions), whether employed or not - so I do understand what the panel was trying to do, too.


The CDC was in an awkward position to create guidelines for use and public health, after they inherited what most feel like is an incomplete authorization for "on-label" use by the FDA.  


The best authorization by the FDA would've been those 50 and older and others at greater risk due to health conditions, are immunocompromised, or are on immunosuppressive agents -  regardless of employment status (but perhaps including front-line healthcare workers)  - but the FDA didn't specify only healthcare workers  :/


The "over 18 by employment risk" thing is just weird and vague and will also cause a lot of authorized use questions and confusion for providers and payers over what constitutes being an "at-risk" job, but that's what the FDA said.

I mean, what does that mean, and how can you prove it?

(In fact, it sounds very Republican to me, only focused on making sure the laborers are protected - at least until they fall down dead and can be replaced, but eff the weakest members, the elderly and the infirm - and the FDA is already suspected to be Republican-legacy-led after the whole Aduhelm thing, breaking its own rules and appearing to collaborate with a Big Pharma company rather than objectively rule on it.)


In my opinion, food authorization and drug authorization should be two separate agencies anyway, unless a pharmaceutical is found within food, and then perhaps a product would need authorization by both.

I could be wrong, but I think we're the only Western country that puts our food and pharmaceuticals together in one agency.  Most European countries, for example,  have separate agencies or ministries for food and pharmaceuticals.


But then we're America and have to be different - sometimes this has been a good thing, and other times, not so much.

Because though we have some of the best education and training in the world for healthcare, we often over-streamline and overly trim our government, cutting off our noses to spite our faces, because people here fear the government control too much (when in actuality, our government is one of the most lenient in the Western world).

Don't get me wrong, I'm all for trimming the fat from government  and getting rid of government waste - but combining food and drug authorizations into one agency is not the way to do this, IMO.


Though the CDC has a choice to publish different guidelines, it has rarely, if ever, done so - that would be unprecedented, at least with such a high-profile treatment and life-threatening illness.

However, also unprecedented would be for the CDC to break with its advisory panel - which it actually did, this go round.

I get it, though - the CDC was between a rock and a hard place - because as I said, it was the wisest choice to avoid provider and payer confusion on authorized "on-label" use, as well as avoid a internal/constitutional war with the FDA. 


Keep in mind, however, that this was a difficult decision for all, because Pfizer's study was small, only done in Israel, and did not show meaningful clinically statistical significance for a third shot of the same formulation.

In other words, the FDA's authorization is mostly speculative anyway,  rather than based on hard evidence, only because we have nothing else.  



Otherwise, I'm reading an article this morning about a series of studies published in the New England Journal of Medicine proving Moderna's vaccine being effective for longer.


Which of course sets Moderna in a good position to be next authorized for a third shot with the FDA - HOWEVER - what is also does, by default, is also help Pfizer, in a way - by proving the efficacy of vaccines does wane over time - something that Pfizer was unable to prove definitively in their small study.


Well, that's awesome for Moderna, but being a small company, they had supply issues.

In fact, I wanted Moderna's vaccine from the start, because of the extra subgroup study, but by the time my subgroup was authorized, here in Kentucky, they ran out and all that was left was Pfizer's.

Don't get me wrong, both Pfizer and Moderna kick butt with protection nearly equally - but these studies apparently show Moderna's effectiveness lasts longer.




So ...then my next question would be, if Moderna gets FDA approval for a third shot, too, in a few months, their studies having proven longer efficacy - what happens if your first two shots were Pfizer, but you want your third shot to be Moderna?

Or vice versa - in fact, that question comes into play now for some - because what if you had Moderna the first go round, and you want, and are authorized as eligible population for, the Pfizer booster - what happens and can they do that?


Now, the official answer should be "NO" - because crossing Pfizer with Moderna shots hasn't been  authorized because it hasn't been studied.


HOWEVER -  are all booster givers going to check your card, which vaccine version you got, before they administer it?

For example, we know already that some people were given third shots of Pfizer before it was authorized. 

Also, I know that some people who lost their cards, went to a different company to get their second shot, and were given the second shot anyway. 


That is because unlike in most European countries, in America, there's no national or federal government registry database with your actual identifying information on it, that can be checked, before you're given a shot.

In America, though the shots were paid for by the federal government, the federal government did not administer the shots (until it was formally authorized by the FDA for general use, as opposed to emergency use, just over a month ago).

Thus, the shots administered were through private companies (and a few state governments) - which means, of course, you're essentially only registered with the private company registry (or state registry, in some cases, and your private insurance company merely received notification) that you used to get the shots, i.e. CVS, Walgreens, Kroger, etc.


Regardless, they better study crossing vaccines and make a decision on that quickly, because it's going to happen, authorized or not.

Plus people want that choice between drugs, especially in America.

Supply issues can't be helped, of course - but they better figure it out soon, because we need to be forward thinking (while still following the science)







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