Navy Reserve COVID Vaccinations by October

[Pags]

The intent of my argument about labeling was to point out an issue with regulation and enforcement. A fancy can of Bud Light still has the same required labeling that any alcoholic beverage requires to be legally sold, and is still labeled as “Bud Light” somewhere.

Think of it this way. I have an experimental airplane that I want to sell to customers, and eventually certify. After selling a bunch, I finally get it certified. I continue churning out airplanes that have “experimental” labeling on them and none of the required certification labeling. It’s the same airplane, so who cares, right? My customers need to fly, and I need to make money.

Turns out, the FAA cares a lot, and shuts me down. Just like they’d punish a pilot for flying a perfectly fine airplane without the required documentation on board. With me so far?

So, again, why is it OK to mandate a vaccine when that vaccine is not available under approved FDA labeling? This at least need to be addressed publicly. I’m looking for honesty and transparency here, and I’m not seeing any.

I understand fully what you're saying wrt airplanes. And usually there's a specific, if minute, technical or paperwork difference between the experimental and regular aircraft. But if there actually isn't a difference then your company needs to articulate that to the FAA and not let your customers deal with using an experimental aircraft in the real world.

But, as I said, I get the argument. For the specific case of the Pfizer dose my understanding is that the only difference is the sticker and what the FDA approval paperwork says. Now, I haven't seen the formal FDA paperwork so perhaps it draws the line between the two different stickers or the fact that what's in each bottle is the same. Or it says that the old bottles are chemically equivalent and are an approved substitute.

So unless there's something I'm missing then it seems like frantic sea lawyering that could be solved by new stickers or by paperwork that says "these are the same (if it doesn't already exist)."

 

[bubblehead]

A service member waiving an ADSEP board isn't cutting corners. It is, and always has been, part of the process.

How dare you!! Stop point out facts ??

MILPERSMAN 1910-226 for you Sea Lawyers accusing people of cutting corners. You cannot waive the board for everything, however.

 

[Mirage]

How dare you!! Stop point out facts ??

MILPERSMAN 1910-226 for you Sea Lawyers accusing people of cutting corners. You cannot waive the board for everything, however.

I'm continually astonished with the lack of reading comprehension here.

Please point out who said trying to convince folks to waive a board is cutting corners? All I asked was what motivation do the sailors who agree to waive the board have?

Cutting corners was discussed wrt the mandate itself applying to a vax with labels that do not exists. It might be nit picky, and seems silly to me, but I won't be surprised at all if at some point a judge decides that no correctly labeled and authorized vaccines exist, so it was impossible for sailors to comply with the order by the deadline. The lawsuits have already been filed. But I'm sure the judge in that lawsuit will take your word for it that no corners were cut.

 

[sevenhelmet]

I understand fully what you're saying wrt airplanes. And usually there's a specific, if minute, technical or paperwork difference between the experimental and regular aircraft. But if there actually isn't a difference then your company needs to articulate that to the FAA and not let your customers deal with using an experimental aircraft in the real world.

But, as I said, I get the argument. For the specific case of the Pfizer dose my understanding is that the only difference is the sticker and what the FDA approval paperwork says. Now, I haven't seen the formal FDA paperwork so perhaps it draws the line between the two different stickers or the fact that what's in each bottle is the same. Or it says that the old bottles are chemically equivalent and are an approved substitute.

So unless there's something I'm missing then it seems like frantic sea lawyering that could be solved by new stickers or by paperwork that says "these are the same (if it doesn't already exist)."

I can make my question even simpler: If it’s as simple as changing a label to meet FDA approval, why haven’t they?

As far as I can tell, two possibilities exist: it’s not that simple, or it’s to Pfizer/USG’s advantage somehow to not update the labeling. Either way, I’m curious why more people haven’t been talking about this, and I’m willing to be educated if pointed in the right direction.


One postulation I’ve discussed with friends is that the label change is being slow-rolled so demand is spread evenly among the 3 vaccines. If Comirnaty is available under approved label, what reason would most people have to use the other two under EUA? However, that brings us to the subject of mandates, and enforceability. It would seem the government is trying to have their cake and eat it too. I’m fairly sure there is a legal difference in enforcing a mandate on a pharma product authorized under EUA, versus one that is used under an approved label. But it’s being discussed as if it’s the latter when- legally, it seems to be the former. That smacks of an abuse of power, and if it isn’t, that needs to be made objectively clear.

You never know, the clarification might even convince a few people to get vaccinated. What I find objectionable is the arrogance of the mandate, and the seemingly intentional divisiveness with which it’s been instituted. “Take this, and don’t you dare ask questions.” I say this as someone who got willingly vaccinated against COVID-19 last spring, so if that completely undermines my credibility on this subject, so be it.

 

[Brett327]

I'm continually astonished with the lack of reading comprehension here.

This is so meta.

 

[Pags]

I can make my question even simpler: If it’s as simple as changing a label to meet FDA approval, why haven’t they?

As far as I can tell, two possibilities exist: it’s not that simple, or it’s to Pfizer/USG’s advantage somehow to not update the labeling. Either way, I’m curious why more people haven’t been talking about this, and I’m willing to be educated if pointed in the right direction.

Or that it's not in the contract. I've seen this same sticker issue in the DOD and no one is going to swap out millions of labels for free (although I did once offer up the services of my children who loved stickers at the time).

So yes, it'd cost more $$$. Maybe it's someone being a good steward of your tax dollars instead of spending millions on stickers.

 

[sevenhelmet]

Or that it's not in the contract. I've seen this same sticker issue in the DOD and no one is going to swap out millions of labels for free (although I did once offer up the services of my children who loved stickers at the time).

So yes, it'd cost more $$$. Maybe it's someone being a good steward of your tax dollars instead of spending millions on stickers.

Contractual stipulations is certainly a possibility, although I think the “good steward” part is a little naive. I’d like to think government officials consider tax dollars carefully but, in my experience, they don’t (unless I’m trying to stay in a hotel in the good part of town). Contracts can also be changed during the execution phase, and the cost of one label vs another should not be significant. In addition, the FDA approval wasn’t a surprise, so why the slow-roll in response?

If a contract limitation the case (or whatever the real reason for the discrepancy) the appropriate official should just SAY that, and not expect people to blindly fall in line. Treat people like adults, and they’ll tend to act the part more often than when treated like children.

 

[bubblehead]

Are f**cking stickers and labels really the basis for some people's legal arguments?

 

[sevenhelmet]

Are f**cking stickers and labels really the basis for some people's legal arguments?

They sure seem to matter to the government. Until they don’t. I’d just like to see some consistency.

 

[bubblehead]

They sure seem to matter to the government. Until they don’t. I’d just like to see some consistency.

I am honestly curious to read the legal pleading.

 

[Tycho_Brohe]

The intent of my argument about labeling was to point out an issue with regulation and enforcement. A fancy can of Bud Light still has the same required labeling that any alcoholic beverage requires to be legally sold, and is still labeled as “Bud Light” somewhere.

Think of it this way. I have an experimental airplane that I want to sell to customers, and eventually certify. After selling a bunch, I finally get it certified. I continue churning out airplanes that have “experimental” labeling on them and none of the required certification labeling. It’s the same airplane, so who cares, right? My customers need to fly, and I need to make money.

I doubt, though certainly can't say for sure, that doses made after the FDA approval would still be labeled as EUA or BNT-whatever the old name was. The thing is, Pfizer has made hundreds of millions of these doses in the past year, prior to FDA approval. Is it really worth re-labelling all the remaining old doses, which are exactly the same as the new doses, considering almost nobody cares about the naming distinction? Is a requirement to do so listed in the approval paperwork from the FDA?

 

[Hair Warrior]

Yeah I’m aware of what it does. Just interesting how you frame it. For all practical purposes, a vaccine being something that triggers an immune response to develop an immunity is a perfectly fine definition. If you’re going to say that the mRNA shots aren’t vaccines for all intents and purposes because they don’t have the pathogen, then that’s peak pedantic and pointless.

If from now on on Airwarriors somebody says “vaccines” and they mean both the mRNA and traditional ones, please do everyone a favor and don’t “aCtUaLlY” them. There’s no point. The person is not trying to convey the message of a pathogen or not, they’re conveying a message of artificial immunity.

It’s a pretty big difference medically. This wide use of mRNA to innoculate people - c’mon, any rational person can look and see that this is very new and first of its kind. The administration had a whole Warp Speed program bc it was so new and different and required expedited reviews and approvals beyond regular channels. The drug makers have been granted immunity - which they asked for specifically bc the waters are uncharted and they didn’t want the liability.

And it’s no more pedantic than correcting someone about the difference between NFOs and Navy pilots.

 

[Brett327]

Still a vaccine. Seriously dude. You wonder why people here give you shit. It's nonsense like this.

 

[sevenhelmet]

I doubt, though certainly can't say for sure, that doses made after the FDA approval would still be labeled as EUA or BNT-whatever the old name was. The thing is, Pfizer has made hundreds of millions of these doses in the past year, prior to FDA approval. Is it really worth re-labelling all the remaining old doses, which are exactly the same as the new doses, considering almost nobody cares about the naming distinction? Is a requirement to do so listed in the approval paperwork from the FDA?

Good question. What I’m most interested by is nobody knows the answer, or seems to care.

Maybe it’s because I work in a HEAVILY regulated industry where even the best efforts often aren’t good enough to satisfy regulators, but given the sheer number of people this affects, it would be nice to have more transparent info on what heavy lifting is being done to address issues like these. Could take some of the wind out of the “big pharma conspiracy” crowd to boot.

 

[Mirage]

Just the fact that the vax was fully approved many months ago now makes it weird no "Comirnaty" doses have been produced and it's not even a registered drug in the database yet. Agreed it just gives folks one more thing to question and wonder about.