Cumberland Falls, Cumberland Falls State Park, Honeybee/Corbin, Kentucky

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Sunday, December 20, 2020

Links to: 1) FDA Advisory Committee's Approval of COVID Vaccines, 2) NEJM Articles on COVID Vaccines, and 3) The CDC's Statement on Allergic Reactions to COVID vaccines


Make of these what you will, but here are links to PDFs of the FDA Advisory Committee's publicly released approvals for both Pfizer and Moderna's vaccines. 

1)  PDF of the FDA approval of Pfizer/BioNTech's vaccine.  

2) PDF of the FDA approval of Moderna's mRNA-1273 vaccine. 

Additionally, results were just published in the New England Journal of Medicine.

Here are the NEJM articles for Pfizer's BNT162b2 vaccine: 

(Note:  Pfizer actually had a first draft found called BNT162b1 that was effective, but had side effects - their second version, BNT162b2, was the product launched and approved by the FDA.)

1) NEMJ: Safety and Efficacy of  BNT162b2 mRNA.

2) NEMJ: Safety and Immunogenicity of BNT162b1 and BNT162b2 versus Placebo.

Here is the recently published article on Moderna's mRNA-1273 vaccine, just FDA-approved for emergency use last Friday:

NEJM: Safety and Immunogenecity of mRNA-1273. 

So what about those severe allergic reactions we've been hearing about?

The CDC has recognized these reported severe allergic reactions as legitimate.  

*HOWEVER*  - their statement about existing drug allergies leads me to believe that there is some suspicion the reactions may be due to other ingredients included in the administration fluid of the vaccine, rather than the mRNA vaccine molecule itself, much like that which already happens in other vaccines. 

For example - this is why you are asked if you're allergic to eggs before receiving the flu vaccine, and why there are two variations of the flu vaccine that do not contain egg proteins for people with severe egg allergies. 

Apparently, the causes are still being investigated, but the CDC did just document them and verify them as legitimate.

Now, you may be asking yourselves, "Why didn't these show up in the clinical trials as SAE's (severe adverse events)?

Well, actually, these serious adverse events did show up in the trial - even 1% of  40,000 people would be 40 people - and we don't even have 40 reported cases yet. 

(Actually, I'll have to go back and check the above links, but I believe the SAEs ranged from 1% to 9%, depending on vaccine and certain individual factors).  

However, the question is still valid because it is curious we've as many as we've had already, even if still consistent with the clinical trial.

And that, ladies and gentlemen, is the biggest reason I will delay getting the vaccination and observe a bit longer,  other than monitoring for long-term side effects and long-term efficacy - because often, what doesn't happen in a controlled clinical study environment, does happen in real-world application.  The greatest value derived from clinical trials is not that they're the final, conclusive answer, but a general snapshot overall "big picture" impression.

And as I alluded to above, in addition to not knowing possible long term side effects, we still don't know long-term efficacy, because enough time hasn't passed yet - we don't know how long we're protected against COVID with the vaccines, nor do we know if those vaccinated can still carry it/transmit it to others.

Now -  I understand that mRNA technology has been in the works for 10 years - but not on SARS-CoV2 specifically.

Thus, simply telling me "It's been in the works in prep for a pandemic for 10 years" does NOT reassure me that the vaccine specifically made for SARS-CoV2 wasn't rushed and is fully ready. 

That is NOT a reassuring argument - that's like telling me we've had the technology for self-driving cars, for the last 20 years, and they passed all their crash tests in labs.

Then what happened when we put them on the streets in the real world -  particularly in certain specific car models? 

CRASH - people died.  

Whups, serious problems.

*NOT because anyone's (necessarily) "hiding" anything , but because too many variables naturally exist in the real world that were innocently and legitimately not thought of/encountered/observed/included in controlled clinical trials*

In fact, I am always amazed, transcribing these interviews, at what variables that particularly the real-world clinicians and pharmacists come up with, which were overlooked during initial study design research.

In fact,  that is why manufacturers do these KOL interviews before they actually perform the study or launch a product - to see if there's any variable they might have missed.

Even still, sometimes, something still gets left off - not because anyone's hiding anything, but because we're human - we just didn't think of that possibility, at the time.

And this premise is why I'd like to wait longer - we just haven't had time to consider all of the variables that naturally exist in real-world application.

Also, telling me that vaccines aren't a big money-maker for companies doesn't help reassure me either.

That's apparently true, vaccines aren't big money-makers as far as immediate actual sales - but they still will make some profit - and they certainly are big money makers, when it comes to new stock-holding investments in the companies themselves, now aren't they? ;)

I'm in good company, apparently, listening to NPR - and not from political people and/or crazy anti-vaccer conspiracists - about half of the reputable medical community wants more time to observe, too, having the exact same questions that I do.

Thus, again, if/when I get the vaccine - and I'd better get a choice - I'm still leaning towards Moderna's, due to what I felt like was a more comprehensive demographic inclusion of the population, plus being a bit more careful to subsegment subpopulations, based on age, reproductive status, and underlying health conditions than Pfizer did. 

Otherwise, I'll observe for quite a while longer first, if you don't mind - because these vaccines seem to me to be not unlike the "self-driving cars" of the pharmaceutical world lol - great performance in a controlled lab environment, but too many variables exist in the real world we haven't encountered yet  ;)


UPDATE:  As of 11 a.m. on 12/22/2020 ...

Dr. Anthony Fauci received Moderna's vaccine today.

Kentucky Governor, Andy Beshear, received Moderna's vaccine today.

VP-elect Kamala Harris is expected to receive Moderna's vaccine on Friday.

VP Mike Pence and President-Elect Biden have instead received Pfizer's vaccine this past week. 

Thus, I feel like I'm in pretty good company, leaning towards Moderna, as I've said repeatedly - that is, if we lowly people get to choose, rather than our insurance company/local governments choose for us - and after a longer period of observation  ;)

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