Always Check the Label!

[BeauGeste]

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.

The unchallenged point here is that there is a significant legal distinction between a brand drug that has been FDA-approved (and therefore compatible with 10 U.S.C. § 1107a), and a drug that continues to be identified (by Pfizer itself, mind you) as experimental, i.e., "received an EUA from the FDA." See the careful distinction between the two drawn out by Pfizer in the "Indication & Authorized Use" section of Pfizer's own statement:

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older | Pfizer

COMIRNATY is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories...

www.pfizer.com

As for Kaiser, I don't see that it says Comirnaty™ is available. Kaiser has no incentive to distinguish between the two vaccines because, medically speaking, the two vaccine versions "have the same formulation and can be used interchangeably." But is there actual evidence that Kaiser or anyone else is now has Comirnaty™ stocked and available in the US? It may happen before December, but has not so far.

The now tiresome point remains that these are two legally distinct (even if chemically identical) vaccines, only one of which the DOD is lawfully able to mandate (and, as KPEngineer points out, only mandate for those to whom it may lawfully mandate, which apparently does not include mids).

if you are a MIDN and you don't comply you're going to be doing your waiting outside Vickey Gate as of December 29.

No real disagreement, but no fun, and very sad for the relative few unvaccinated mids. But, in the absence of little jars of Comirnaty™ readily available, they'll at least have a very strong claim for reinstatement, for what that's worth.

 

[FutureAcademyDad?]

The unchallenged point here is that there is a significant legal distinction between a brand drug that has been FDA-approved (and therefore compatible with 10 U.S.C. § 1107a), and a drug that continues to be identified (by Pfizer itself, mind you) as experimental, i.e., "received an EUA from the FDA." See the careful distinction between the two drawn out by Pfizer in the "Indication & Authorized Use" section of Pfizer's own statement:

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older | Pfizer

COMIRNATY is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories...

www.pfizer.com

As for Kaiser, I don't see that it says Comirnaty™ is available. Kaiser has no incentive to distinguish between the two vaccines because, medically speaking, the two vaccine versions "have the same formulation and can be used interchangeably." But is there actual evidence that Kaiser or anyone else is now has Comirnaty™ stocked and available in the US? It may happen before December, but has not so far.

The now tiresome point remains that these are two legally distinct (even if chemically identical) vaccines, only one of which the DOD is lawfully able to mandate (and, as KPEngineer points out, only mandate for those to whom it may lawfully mandate, which apparently does not include mids).


No real disagreement, but no fun, and very sad for the relative few unvaccinated mids. But, in the absence of little jars of Comirnaty™ readily available, they'll at least have a very strong claim for reinstatement, for what that's worth.

1. There is definitely a legal difference between Comirnaty and the Pfizer Covid-19 Vaccine in that Pfizer is now allowed to market Comirnaty to individuals 16 and above because the FDA has granted full approval for that purpose. The ability to market the product is the key legal difference between the two. There is nothing experimental about Comirnaty when used for the fully authorized purpose.

2. The Pfizer Covid 19 Vaccine remains under the emergency use authorization for purposes other than administration to individuals 16 years of age and older.

3. Again, the DOD is legally authorized to mandate the vaccine for it's fully authorized purpose, because from a medical administration perspective, there is only one product.

4. Anyone who tries to use your argument to avoid a mandate, whether from DOD, DOT, any other government agency, or a private employer, will fail. Miserably.

I agree that your argument has become, and has been from it's inception, tiresome, because there is absolutely no foundation for it. Essentially, you are arguing that the FDA fully approved a vaccine that doesn't yet exist.

Don't you see the illogic of that argument? Oh wait, of course you don't.

But maybe, some less entrenched individuals will, which is the only reason I continue to rebut this silliness.

 

[nuensis]

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.

Reference NAVADMIN 190/21, which provides guidance for implementation (i.e. fixes this).

 

[KPEngineer]

Reference NAVADMIN 190/21, which provides guidance for implementation (i.e. fixes this).

Nope ... the NAVADMIN actually adds to the argument that the DoD mandate does not apply to USMMA M/N.

2.a. Navy Service Members. Active duty service members, service members in
the selected reserve, and service members in the Individual Ready Reserve are
considered Navy service members for the purposes of this NAVADMIN.

USMMA M/N are not Active Duty, Selected Reserve, or IRR unless things have significantly changed. At the bottom of the Page 13 it has a block "Branch and Class" It is already filled in USNR-202 with room for more "___" What does that mean is my question. Does the "202" confirm USMMA M/N are in fact S2 which are not "Navy serve members for the purposes of this NAVADMIN."

The SECDEF Memo, the SECNAV ALNAV Message and the CNO NAVADMIN Message ALL limit the mandate to the Ready Reserve which USMMA M/N are not.

Where in the chain of command did this order get expanded? On what authority? If the person who expanded it did not have authority to do so, then is it in fact a lawful order under the UCMJ?

 

[nuensis]

Nope ... the NAVADMIN actually adds to the argument that the DoD mandate does not apply to USMMA M/N.

2.a. Navy Service Members. Active duty service members, service members in
the selected reserve, and service members in the Individual Ready Reserve are
considered Navy service members for the purposes of this NAVADMIN.

USMMA M/N are not Active Duty, Selected Reserve, or IRR unless things have significantly changed. At the bottom of the Page 13 it has a block "Branch and Class" It is already filled in USNR-202 with room for more "___" What does that mean is my question. Does the "202" confirm USMMA M/N are in fact S2 which are not "Navy serve members for the purposes of this NAVADMIN."

The SECDEF Memo, the SECNAV ALNAV Message and the CNO NAVADMIN Message ALL limit the mandate to the Ready Reserve which USMMA M/N are not.

Where in the chain of command did this order get expanded? On what authority? If the person who expanded it did not have authority to do so, then is it in fact a lawful order under the UCMJ?

Same page. No argument. The ALNAV is flawed; the NAVADMIN clarifies further.

 

[TheRightStuff]

George Washington, founding father of this country, required our troops to be vaccinated against smallpox. This undoubtedly assisted in the efforts to win the Revolutionary War and in turn, helped found the United States of America.

Just sayin'.......

Where did the article “George Washington and the First Mass Military Inoculation” go? - Ask a Librarian

www.loc.gov

 

[KPEngineer]

George Washington, founding father of this country, required our troops to be vaccinated against smallpox. This undoubtedly assisted in the efforts to win the Revolutionary War and in turn, helped found the United States of America.

Just sayin'.......

Whether or not the Military can or should mandate the COVID shot hasn’t actually been questioned in this thread.

What has been questioned is simply whether or not that mandate applies to the M/N at USMMA.

The Secretary of Defense, Secretary of the Navy, and Chief of Naval Operations, in their written guidance all limited the mandate to some portion of the Reserve Component and DID NOT mandate with a broad brush that everyone with military status get the shot. Simply saying that USMMA M/N are in the Navy Reserve and so must abide by the SECDEF, SECNAV and CNO mandate is either overly simplistic or agenda driven.

If I were a current M/N who had not had any of the shots and didn’t want on I would simply ask for clarification on applicability noting that SECDEF, SECNAV and CNO did not mandate someone with my status get a shot. Where between CNO and USMMA NavSci did the order get expanded from Ready Reserve to Ready and Inactive Reserve? Threatening someone with ADSEP over for non-compliance with an order given to someone else is not leadership but bullying.

If a USMMA M/N went to NavSci and asked for orders to a local reserve unit so they could drill for pay they would be told they are not eligible because they are not in the Ready Reserve. If I am not in the Ready Reserve why am I being held to Ready Reserve standards under the threat of Admin Separation?

And it’s not sea-lawyering when there is actual case law that M/N are not in the Ready Reserve. Someone took it to court and it was adjudicated that you cannot earn retirement points for your time as a M/N in the reserves because you are not in the Ready Reserve.

I know there are some current M/N lurking here. I would love for one of them to look at their Navy paperwork and tell us what their USNR status is. Is it SELRES, IRR, S1 or S2?

 

[TheRightStuff]

I understand that can/should hasn’t been discussed here, it was a point of reference to add to the context of interpretation.

 

[BeauGeste]

George Washington, founding father of this country, required our troops to be vaccinated against smallpox. This undoubtedly assisted in the efforts to win the Revolutionary War and in turn, helped found the United States of America.

Just sayin'.......

Where did the article “George Washington and the First Mass Military Inoculation” go? - Ask a Librarian

www.loc.gov

As well he should. The most common strain of smallpox "has a case-fatality rate of about 30%." God Bless George Washington and all the Founding Fathers!

From the FDA: "Variola major is the severe form of smallpox, with a more extensive rash and higher fever. It is also the most common form of smallpox. There are four types of variola major smallpox: ordinary (the most frequent); modified (mild and occurring in previously vaccinated persons); flat; and hemorrhagic. Historically, variola major has a case-fatality rate of about 30%. However, flat and hemorrhagic smallpox, which are uncommon types of smallpox, are usually fatal."

Smallpox

Smallpox is a serious, highly contagious, and sometimes fatal infectious disease. There is no specific treatment for smallpox disease, and the only prevention is vaccination. The name is derived from the Latin word for "spotted" and refers to the raised bumps that appear on the face and body of...

www.fda.gov

 

[BeauGeste]

1. There is definitely a legal difference between Comirnaty and the Pfizer Covid-19 Vaccine in that Pfizer is now allowed to market Comirnaty to individuals 16 and above because the FDA has granted full approval for that purpose. The ability to market the product is the key legal difference between the two. There is nothing experimental about Comirnaty when used for the fully authorized purpose.

Here, we are in agreement. The two vaccines are legally distinct, as Pfizer again admitted in a Fact Sheet released last week. (See below -- I can't seem to paste Pfizer's 9-22-21 "Fact Sheet" right here.)

2. The Pfizer Covid 19 Vaccine remains under the emergency use authorization for purposes other than administration to individuals 16 years of age and older.

Almost correct. Check the Fact Sheet below. The Experimental Use Authorization ("EUA") vaccine is authorized for pretty much anyone over the age of 12, not 16.

3. Again, the DOD is legally authorized to mandate the vaccine for it's fully authorized purpose, because from a medical administration perspective, there is only one product.

Here, you traffic in ambiguity. Yes, "the DOD is legally authorized to mandate the vaccine for its fully [approved] purpose." A bit of a tautology, but we assume you're referencing the branded Comirnaty.™ Why? Because the FDA "approval" Pfizer received was for stuff it now labels Comirnaty.™ And the DOD may only mandate an approved vaccine, remember? This has little to do with a "medical administration perspective." Certainly the harried Kaiser doctor will have no qualms about pulling any vaccine -- approved or just "authorized" -- from among what is available. That's a medical perspective. Here we're talking about a legal perspective -- what's legally permissible for the DOD to mandate.

And again, check Pfizer's Fact Sheet. As noted, Pfizer still carefully distinguishes Comirnaty™ from the experimentally approved vaccine, calling them "legally distinct." (Footnote 1.) So not "one product," but two. Just ask Pfizer.

4. Anyone who tries to use your argument to avoid a mandate, whether from DOD, DOT, any other government agency, or a private employer, will fail. Miserably.

We're just talking here about the unique statutory limitation imposed on the DOD's ability to mandate an experimental vaccine. There's been no suggestion on what impact Comirnaty™'s unavailability at your local Kaiser, CVS, Walgreens, RiteAid, etc., would have in other situations. Hate to be rude, but your conflation of the legally unique DOD situation with other legally distinct situations kind of gives you away.

I agree that your argument has become, and has been from it's inception, tiresome, because there is absolutely no foundation for it. Essentially, you are arguing that the FDA fully approved a vaccine that doesn't yet exist.

Self knowledge and humility are virtues. Slipshod arguments are not. What I've argued is that the FDA has approved a vaccine that certainly exists, but which Pfizer has not yet actually made available for US pharmacy shelves. At least as far as anyone can tell. Sounds like a foundation. Is there an offer to post a photo of Comirnaty™ bottles just waiting to be used at your local pharmacy? Perhaps not.

Check the label.

Oh, and here's the Pfizer "Fact Sheet" from last week. Take special note on how many times it carefully distinguishes between the two vaccines. Comirnaty each time described as actually "FDA-approved," the other "FDA-authorized ... under Emergency Use Authorization." I lost track at the 15th repetition.

Pfizer-BioNTech COVID-19 Vaccines

Comirnaty, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

www.fda.gov