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Message
re: So where is the OSHA mandate?
Posted on 10/5/21 at 3:46 pm to Indefatigable
Posted on 10/5/21 at 3:46 pm to Indefatigable
quote:
The FDA has acknowledged that,
You're going to have to link this please. I have not read this. Everything you have written in your post are assumptions that sound plausible but remain assumptions.
In fact in the FDA FAQ I linked doctors are required to inform their patients receiving the BioNTech-Pfizer vaccine that the vaccine remains under EUA.
0
Posted on 10/5/21 at 3:48 pm to Indefatigable
quote:
That is your legal distinction. Just as Tylenol and walgreens-labeled acetominaphen are "legally distinct" despite being made on the same assembly line and being otherwise totally identical.
Where are you reading this?
quote:
The FDA has already stated that the two vaccines are identical in formulation and effect, and that they are interchangeable.
I know. I read that.
quote:
Its a manufacturing hurdle, and nothing more.
Where are you reading this?
Posted on 10/5/21 at 3:50 pm to Strannix
I can give you my 2 cents...
I am a Safety Manager by occupation, over 10 years of experience
A lot of experience dealing with OSHA, some with OSHA lawyers, and even have a few friends that are OSHA Reps
Legally, the mandate has no standing
OSHA's main purpose is the right to safe workplace
OSHA cannot regulate a safe workplace if 100% of the population isn't mandated.
Example 1: Fall Protection: By only saying companies with 100 employees have to get the shot, is like saying only companies with 100 people are require to wear fall protection at 6ft(1926) and 4ft(1910) You can't enforce the rule if not everyone is required to follow it
Example 2: Business (Retail): So say all Wal-Mart employees are required to get the shot because it employs over 100 people. Well, if I work for a company with less than 100 people and don't get the shot, then I go to Wal-Mart, by this "regulation", I just created an unsafe workplace for Wal-Mart employees....but I am not required to get the shot so I am not at fault.
It has to be 100% of the population or none (ie the 14th Amendment - Equal protection of the law)
But then again.... We are dealing with the administration that is constantly breaking the law
I am a Safety Manager by occupation, over 10 years of experience
A lot of experience dealing with OSHA, some with OSHA lawyers, and even have a few friends that are OSHA Reps
Legally, the mandate has no standing
OSHA's main purpose is the right to safe workplace
OSHA cannot regulate a safe workplace if 100% of the population isn't mandated.
Example 1: Fall Protection: By only saying companies with 100 employees have to get the shot, is like saying only companies with 100 people are require to wear fall protection at 6ft(1926) and 4ft(1910) You can't enforce the rule if not everyone is required to follow it
Example 2: Business (Retail): So say all Wal-Mart employees are required to get the shot because it employs over 100 people. Well, if I work for a company with less than 100 people and don't get the shot, then I go to Wal-Mart, by this "regulation", I just created an unsafe workplace for Wal-Mart employees....but I am not required to get the shot so I am not at fault.
It has to be 100% of the population or none (ie the 14th Amendment - Equal protection of the law)
But then again.... We are dealing with the administration that is constantly breaking the law
This post was edited on 10/5/21 at 3:52 pm
Posted on 10/5/21 at 3:52 pm to Strannix
quote:
It would take 5 minutes to issue
Is this the way you go through life? Not considering any consequences or planning any major decisions?
Posted on 10/5/21 at 3:53 pm to GumboPot
quote:
legal distinction. Just as Tylenol and walgreens-labeled acetominaphen are "legally distinct" despite being made on the same assembly line and being otherwise totally identical.
Where are you reading this?
I don't need to read anything to know that two products, whether identical or not, that have different marketing names are legally distinct. There may not be an industry where this is as common as medicine and pharmaceuticals, which is why I don't understand how so many are confused by it.
quote:
Its a manufacturing hurdle, and nothing more.
Where are you reading this?
The FDA's formal notice of authorization to Pfizer states it:
quote:
Although COMIRNATY...is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety
I know you desperately want this to be a thing, but it isn't. This distinction you are drawing between the two is effectively meaningless and has no bearing on the legality of OSHA's never-going-to-happen mandate.
OSHA can't issue the mandate because promulgating a rule requiring only a portion of the population to do something on an arbitrary basis (number of employs) is unconstitutional.
This post was edited on 10/5/21 at 3:59 pm
Posted on 10/5/21 at 3:53 pm to LSUweights
quote:
LSUweights
Excellent post.
Posted on 10/5/21 at 3:56 pm to GumboPot
quote:
GumboPot
Thank You Sir
This post was edited on 10/5/21 at 3:57 pm
Posted on 10/5/21 at 4:00 pm to Indefatigable
quote:quote:
The FDA's formal notice of authorization to Pfizer states it:
quote:
Although COMIRNATY...is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety
I'm calling bull shite on Pfizer's inablity to get ramped up on relabeling existing BioNTech-Pfizer vaccine vials. This just sounds like a convenient excuse to continue to issue BioNTech-Pfizer under EUA and nothing more.
We are dealing with a multibillion dollar company. Switch the damn labels from BioNTech-Pfizer to Comirnaty in your manufacturing facility. It would probably take less than 30 minutes for some technician to do this.
Posted on 10/5/21 at 4:01 pm to BROffshoreTigerFan
quote:
You already have to answer questions about the covid vaccine when applying for jobs. It doesn't matter if the mandate comes down or not. It worked.
Not for everyone, my POE is waiting for the OSHA rule.
"mandatory vaccination will not be implemented."
Global company, 30K+ employees.
Posted on 10/5/21 at 4:02 pm to GumboPot
quote:
I'm calling bull shite on Pfizer's inablity to get ramped up on relabeling existing BioNTech-Pfizer vaccine vials.
They can’t do that, and do you really want big pharmacy swapping labels on vials post production?
They have to make them under the Comirnaty label if they are operating and marketing them under the full authorization. As we’ve already established, they are legally distinct products. That’s exactly why the generic version got a renewed EUA—to continue distribution while approved and labeled vials of the vaccine are produced.
Besides, It’s not like Pfizer has all the generics just sitting around. They are shipped as they are made. They would have to get them all back to re-label them.
quote:
This just sounds like a convenient excuse to continue to issue BioNTech-Pfizer under EUA and nothing more.
To what end, exactly, would they do that? Who benefits from that?
quote:
Switch the damn labels from BioNTech-Pfizer to Comirnaty in your manufacturing facility.
See above. That isn’t how it works.
This post was edited on 10/5/21 at 4:10 pm
Posted on 10/5/21 at 4:09 pm to Indefatigable
quote:
I know you desperately want this to be a thing, but it isn't. This distinction you are drawing between the two is effectively meaningless and has no bearing on the legality of OSHA's never-going-to-happen mandate.
It only has a bearing in terms of employer basing their mandate on a fully approved vaccine and I agree that it has no bearing on the legality of OSHA enforcement.
Seriously, if BioNTech-Pfizer and Comirnaty are the same thing just fully approve BioNTech-Pfizer then this entire issue evaporates.
quote:
OSHA can't issue the mandate because promulgating a rule requiring only a portion of the population to do something on an arbitrary basis (number of employs) is unconstitutional.
I agree with this.
Posted on 10/5/21 at 4:13 pm to GumboPot
quote:
Seriously, if BioNTech-Pfizer and Comirnaty are the same thing just fully approve BioNTech-Pfizer then this entire issue evaporates.
The vaccine being submitted for approval as Comirnaty is the reason for this piece.
Point being it’s not really an issue. It’s a legal quirk that uniquely appears here because of the speed all this was developed and the fact that the “generics” are still EUA while the name brand is fully authorized.
quote:
It only has a bearing in terms of employer basing their mandate on a fully approved vaccine
Eh. Maybe. My opinion is that the FDA is providing cover on that through the “interchangeable” language but it would make for an interesting case. However any litigation on that is going to be mooted by Comirnaty (or Moderna’s impending approval) becoming available
Confusing and nuanced? Definitely. Conspiracy or legal end-around? Nah. Just a product of the red tape our alphabet agencies have created over the decades.
This post was edited on 10/5/21 at 4:18 pm
Posted on 10/5/21 at 4:15 pm to LSUbest
quote:
Not for everyone, my POE is waiting for the OSHA rule.
You're right. 3 out of the 5 I filled out today had questions about Covid vac status.
I'm glad your company is doing the right thing. The ones here are caving.
Accepting resumes?
Posted on 10/5/21 at 4:24 pm to Indefatigable
But when the rubber hits the road the doctor is still required to tell their patients that the BioNTech-Pfizer vaccine is not an FDA-approved vaccine:
On one had you have the FDA saying the BioNTech-Pfizer vaccine is not an FDA-approved vaccine, your doctor is required to communicate that information to you and then we have people in the MSM and the White House saying the "vaccine" (purposely not being specific) is fully approved.
The logic to go from "not and FDA-approved vaccine" to fully approved rivels string theory in terms of logic.
On one had you have the FDA saying the BioNTech-Pfizer vaccine is not an FDA-approved vaccine, your doctor is required to communicate that information to you and then we have people in the MSM and the White House saying the "vaccine" (purposely not being specific) is fully approved.
The logic to go from "not and FDA-approved vaccine" to fully approved rivels string theory in terms of logic.
Posted on 10/5/21 at 4:27 pm to Strannix
Mandating that employers with over 100 employees require vaccines or testing of its employees is a violation of 14th Amendment’s Equal Protection Clause because it doesn’t apply to employees working at companies with 100 or less employees. In addition, exempting USPS workers, members of congress and their staff is also a violation of the clause.
The creation of an OSHA standard to force companies with >100 employees to comply with mandates will define workplace exposure to COVID-19 resulting in illness as a work-related illness and will result in workman’s comp claims and lawsuits.
For a company like Walmart whose employees will be compelled to abide by the mandates, what about the millions of customers that enter Walmart stores each day? Shouldn’t the Walmart employees be afforded the same “protection” from unvaccinated customers entering its stores? By not requiring that customers be vaccinated or have a negative test result, would Walmart not be guilty of creating a “workplace hazard” for its employees?
The creation of an OSHA standard to force companies with >100 employees to comply with mandates will define workplace exposure to COVID-19 resulting in illness as a work-related illness and will result in workman’s comp claims and lawsuits.
For a company like Walmart whose employees will be compelled to abide by the mandates, what about the millions of customers that enter Walmart stores each day? Shouldn’t the Walmart employees be afforded the same “protection” from unvaccinated customers entering its stores? By not requiring that customers be vaccinated or have a negative test result, would Walmart not be guilty of creating a “workplace hazard” for its employees?
Posted on 10/5/21 at 4:29 pm to Strannix
quote:
It would take 5 minutes to issue, i just wonder why they havent issued it yet....
OSHA told the WH they don't have a mechanism for such a mandate and had no idea how they could have such a mandate.
Posted on 10/5/21 at 4:31 pm to GumboPot
quote:
But when the rubber hits the road the doctor is still required to tell their patients that the BioNTech-Pfizer vaccine is not an FDA-approved vaccine:
Of course they are….it isn’t. Only the Comirnaty branded version is. But I don’t know why you think that’s so significant or surprising. They have been required to do that the whole time, same with Moderna and JNJ. As I understand, that’s part of the EUA framework. Blame lawyers for disclaimers like that I guess.
quote:
On one had you have the FDA saying the BioNTech-Pfizer vaccine is not an FDA-approved vaccine, your doctor is required to communicate that information to you and then we have people in the MSM and the White House saying the "vaccine" (purposely not being specific) is fully approved.
Doctors and pharmacists make the same pronouncements when they are giving you generic versions of drugs all the time.
Again, my man, I really, really think you are trying too hard to read something into this situation that isn’t there. What is it that you think is the end to all of this, if tomfoolery is afoot? It’s not like Pfizer gets preferential legal treatment on one hand and not the other. They’re immune regardless, and there are injury compensation programs in both instances.
quote:
The logic to go from "not and FDA-approved vaccine" to fully approved rivels string theory in terms of logic.
The political messaging—I agree. All they needed to do was explain the name difference. Like I said, blame lawyers and government bureaucracy foe the confusion and needless nuance.
But in a practical sense, it’s really a nothingburger.
This post was edited on 10/5/21 at 4:36 pm
Posted on 10/5/21 at 4:34 pm to GumboPot
I agree it's some seriously faulty logic.
They can't say two products are "legally distinct", but the same. Mandate I get it, but dont allow me to get the one legally approved.
Pfizer wants to play marketing and legal games during a pandemic, and then complain when they get called on it. Gtfoh
They can't say two products are "legally distinct", but the same. Mandate I get it, but dont allow me to get the one legally approved.
Pfizer wants to play marketing and legal games during a pandemic, and then complain when they get called on it. Gtfoh
Posted on 10/5/21 at 4:37 pm to Mac Power
quote:
They can't say two products are "legally distinct", but the same.
Cmon baw. That happens ALL the time across all industries, particularly pharma.
quote:
Pfizer wants to play marketing and legal games during a pandemic, and then complain when they get called on it.
They gave their product a name
What legal advantage do you guys think Pfizer is obtaining by this “shadiness”? That’s what I don’t see here. You guys are implying some level of malevolence and/or legal opportunism by Pfizer, but I don’t even understand what that would be?
I mean, if yalls point is that the *actually* approved vaccine is not generally available, then you’re correct. But it’s just a technicality, and a temporary one at that.
This post was edited on 10/5/21 at 4:42 pm
Posted on 10/5/21 at 4:41 pm to Strannix
I’ll take gaslight for $200 Alex
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