Always Check the Label!

[BeauGeste]

Just to be clear, I'm in the 60+ category, and I voluntarily took the Moderna vaccine. My main beef is forcing a vaccine on the very healthy young when: 1) they are very unlikely to suffer any serious or lasting harm from acquiring Covid-19; and 2) the natural immunity they would gain would far exceed the immunity potentially gained from any of the current vaccines.

That said, the only vaccine the DOD may lawfully mandate is the Pfiser variant recently approved by the FDA, called "Comirnaty." Mandating service members to take a vaccine not FDA-approved is prohibited by law (expect in particularly dire circumstances not here present). (See, 10 U.S.C. § 1107a.) Fine, you might say, but now we have the approved Comirnaty. But that is the interesting thing. At least for now, it appears that Pfiser has little interest in actually making and distributing Comirnaty -- it's just not available anywhere. Perhaps Pfiser is more comfortable selling the "experimental" vaccine under the umbrella of legal immunity? Hard to tell. But you can't take a vaccine that's not available.

Wait, you say, Comirnaty is identical to the existing experimental Pfiser, the one that millions have taken. True, but unless it actually says "Comirnaty" on the label, it legally remains the experimental drug, cannot be mandated by he DOD, and good luck trying to enforce such an order. And, so far at least, Pfiser appears to be slow-walking that labelling. We'll see if it becomes available by the new Naval Reserve deadline of December 28, 2021, now made applicable to our USMMA mids.

The DOD is mandating a vaccine that practically does not exist. But what the DOT may require for our long-suffering mids? All bets are off.

 

[JP4]

Heh, the yellow dog and vetoing hecklers will be here shortly to zap this thread.

 

[FutureAcademyDad?]

...That said, the only vaccine the DOD may lawfully mandate is the Pfiser variant recently approved by the FDA, called "Comirnaty."...

...Wait, you say, Comirnaty is identical to the existing experimental Pfiser, the one that millions have taken. True, but unless it actually says "Comirnaty" on the label, it legally remains the experimental drug, cannot be mandated by he DOD, and good luck trying to enforce such an order...

Sorry, but that is simply incorrect. From the FDA:

. ."Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine."...

 

[BeauGeste]

Sorry, but that is simply incorrect. From the FDA:

. ."Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine."...

A civilian "provider" is not the DOD, and is not governed by 10 U.S.C. § 1107a.

 

[FutureAcademyDad?]

That may be so, but that section no longers applies to the Pfizer vaccine with regard to individuals 16 and over, since the vaccine has received full approval.

Apparently all of the branches of the military agree with this assessment, since all of them have used orders setting compliance dates. For example, all active-duty DON personnel must be vaccinated by Nov. 28. Failure to comply with the lawful order is punishable under Article 92, UCMJ.

As per the order of the SecNav on Aug 21.

 

[KPEngineer]

This is a moot argument for this thread. The SECDEF memo only instructs Active Duty and Ready Reserve be mandated the "vaccine". USMMA M/N are neither so any mandates must be based on something else.

 

[BeauGeste]

This is a moot argument for this thread. The SECDEF memo only instructs Active Duty and Ready Reserve be mandated the "vaccine". USMMA M/N are neither so any mandates must be based on something else.

If only it were moot. The USMMA Facebook page posted this unsigned memo yesterday (sorry for the blurry screen shot; check its FB page for the original):

That may be so, but that section no longers applies to the Pfizer vaccine with regard to individuals 16 and over, since the vaccine has received full approval.

Apparently all of the branches of the military agree with this assessment, since all of them have used orders setting compliance dates. For example, all active-duty DON personnel must be vaccinated by Nov. 28. Failure to comply with the lawful order is punishable under Article 92, UCMJ.

As per the order of the SecNav on Aug 21.

Only Comirnaty has been approved. Try asking for it by name at, say, Walgreens.

Requiring a service member to take an unapproved vaccine is not a lawful order. Unanimity among "the branches" does not make it lawful. As I said, good luck attempting to administratively separate a service member who insists on receiving only the approved vaccine.

 

[KPEngineer]

If only it were moot. The USMMA Facebook page posted this unsigned memo yesterday (sorry for the blurry screen shot; check its FB page for the original):

So they are requiring Inactive Reservists to be vaccinated based on a "DOD Policy" which specifically limits itself to Active and Ready Reserve. Good luck with that. That is a very winnable fight.

 

[bob'sburgers]

 

[BeauGeste]

View attachment 10224

I hate to be the house crank on this issue, but allow me to point out a few things, all relating to paragraph 4, the money paragraph.

Notice the insidious ambiguity of paragraph 4. "No later than 28 Dec 2021, you will complete receipt of the COVID-19 vaccination using an FDA approved vaccine...." So far so good, this part is a clear and lawful order. However, this clear language is immediately muddied up by what follows (I paraphrase): "But hey, if you want to take the experimental vaccine, you can do that as an alternative," without clearly saying "By the way, we can only force you to take the Comirnaty." Finally, as the last stab at confusion, it implies that the old Pfizer is really just the same as the new Pfizer, just a "marketing" thing.

The DOD has had months (a year?) to wordsmith this order, and this is best they can do? The ambiguity is, I think, intentional --it confuses the lawfully ordered Comirnaty with the non-Comirnaty vaccines, which can't be lawfully ordered. It is an effort to buffalo as many as possible to take any available experimental vaccine. After all, there is terrific pressure from the Administration to get all military services 100% vaccinated, and yet the DOD knows Comirnaty is simply not available. This is the best they can do.

Very tough situation for mids (and service members). Stand on principle, check the label and insist that it be Comirnaty or nothing, and likely get disenrolled (and of course have recourse to legal action). No fun. Or take whatever vaccine is issued. There is also, for some, the ability to apply for a religious accommodation. Perhaps with the passage of time, naturally acquired immunity will be recognized as "just as good" as the vaccine.

For all my bad-mouthing, this is actually a clearer statement than the one issued by the USMC.

 

[JP4]

Interesting. It says "you will" for the FDA version and names it correctly as Comirnaty. Then, "optionally and alternately" for all the other EUA versions.

As far as I am aware Comirnaty still isn't made or available in this country while there is a flood of the EUA versions. What happens come December 28 (or actually December 14 as it is a two shot administration) if Comirnaty still isn't available?

 

[OldRetSWO]

Interesting. It says "you will" for the FDA version and names it correctly as Comirnaty. Then, "optionally and alternately" for all the other EUA versions.

As far as I am aware Comirnaty still isn't made or available in this country while there is a flood of the EUA versions. What happens come December 28 (or actually December 14 as it is a two shot administration) if Comirnaty still isn't available?

I think that its already been said here but in case it is not, the difference between "Comirnaty" and the former Pfizer (EUA) vaccine is simply the label itself. It is the IDENTICAL vaccineand they are simply slapping their trade name on it.

 

[JP4]

They are not identical. They use the same formulation for the active part (and may have the same exact effect) but they are not entirely the same.

Furthermore they are legally distinct as is stated on page one of the FDA fact sheet for health care providers.

There is a reason they had to put that in there and a reason the letter attached above is worded they way it is. BeauGeste has it right.

There will be others along shortly who will focus on the language just above the footnote stating they are legally distinct that says "The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.1"

The 1 there is for this footnote: "The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."

They can be used to get the same effect as the active part is stated as being the same formulation. They can't both be legally mandated because only Comirnaty is FDA approved.

We will know in three months what ultimately happens. I still wonder what will happen to those that wait for the approved version if this analysis is correct. Will they be seen as selfish or not team players and their future prospects tainted even if legally they were correct? More concerning is what happens if there is an unknown long term consequence to the perhaps close to 100% of service members who get the injections. Will take a bit more than three months to know that one.

Here is a link to the FDA document: https://www.fda.gov/media/144413/download

 

[KPEngineer]

Any arguments regarding the labeling or naming of the drug and whether that is in fact what is FDA approved is a losing argument and won't get you anywhere.

I have issue with this being a "lawful order". If they have to tell you it's a lawful order it usually makes me a little on the skeptical side.

The 30 Aug in item No. 1 is the date of the SECNAV ALNAV message which specifically reference the SECDEF Memo of 24 Aug 2021 as it's underlying authority.

SUBJ/2021-2022 DEPARTMENT OF NAVY MANDATORY COVID-19 VACCINATION POLICY//

REF/A/DOC/SECDEF/24AUG21//

AMPN/REF A IS THE OFFICE OF THE SECRETARY OF DEFENSE MEMO MANDATING
CORONAVIRUS DISEASE 2019 VACCINATION FOR DEPARTMENT OF DEFENSE SERVICE
MEMBERS//

The SECDEF Memo only requires the vaccine for Active Duty and Ready Reserve.

The SECNAV ALNAV exceeded the authority granted by SECDEF Memo by expanding its application to the entirety of the "Reserve Component". Any orders in it or relying on it that go beyond the scope of the SECDEF Memo could be argued then to not be a "lawful orders". Once the SECNAV referenced the SECDEF Memo as his authority to mandate the shot he limited himself to it's scope.

 

[JP4]

"Any arguments regarding the labeling or naming of the drug and whether that is in fact what is FDA approved is a losing argument and won't get you anywhere."

You may be correct on this. We will know come December.

 

[FutureAcademyDad?]

I will leave it at this:

If Comirnaty and the Pfizer-Biontech Covid-19 Vaccine are separate products, then there will be 2 distinct Safety Data Sheets - one for each product.

Go ahead...find me those 2 distinct SDSs.

I'll wait...

 

[KP Eng]

 

[JP4]

I will leave it at this:

If Comirnaty and the Pfizer-Biontech Covid-19 Vaccine are separate products, then there will be 2 distinct Safety Data Sheets - one for each product.

Go ahead...find me those 2 distinct SDSs.

I'll wait...

Still waiting for you to show us where Comirnaty is available in this country.

Lot of waiting going on around here.

 

[KP Eng]

Lot of waiting going on around here.

Lots of sea lawyering too, but something tells me if you are a MIDN and you don't comply you're going to be doing your waiting outside Vickey Gate as of 29 December.

 

[FutureAcademyDad?]

Apparently you can get Comirnaty at Kaiser Permanente:

https://healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.covid-19-vaccine-mrna-bnt162b2pfizerpf-30-mcg-0-3-ml-im-susp-eua.604632

And virtually everywhere else in the country, whether under the brand name, or the generic name.

But, I guess that you consider Advil and ibuprofen to be different medications. And Tylenol and acetaminophen. And Sudafed and pseudoephedrine. And so forth, ad nauseum.