It is very simple. Comirnaty is a BioNtech product, not Pfizer. That is the whole thing. Many people forget that BioNtech and Pfizer are two distinct companies, and their products are hence legally distinct. For completeness, there actually are also in terms of actual product, small differences. This as they are produced in different factories with different supply chains causing small differences in non-active ingredients.
But key is, BioNtech's Comirnaty has never been available in the US ever, except in tiny quantities imported by the military because a judge actually ruled that soldiers could not be forced to take an emergency authorized product.
So practically, Comirnaty is still approved in the US, but has never been available, and BioNtech has no plans to start importing it. So it is moot. All that ever was available here were Pfizer's product variants, and Pfizer's mono-shot is now pulled.
Spikevax is a more interesting story. Spikevax is product wise identical to the Moderna emergency authorized shot. It is however unclear how many Spikevax products were actually administered, as at time of approval there were large stocks of the emergency authorized shots. These may be physically identical, but legally not. It is hence unclear, whether anything was produced and then administered under the legal umbrella of Spikevax.
Nevertheless, Moderna could hence continue selling it today. However, as they also have moved on to the bi-valent shots, this is also moot. It will no longer be produced and hence not administered either.
If you go into get a shot today - as an adult - you'll get the emergency approved bivalent shots.
(For kids the story of course is more simple: there is nothing approved.)
Comirnaty is approved by the FDA (or at least, it was), regardless of whether it was actually sold or distributed in the US or not. Despite the existence of an approved product, Pfizer opted to continue distributing the BioNTech formulation under the aegis of an Emergency Use Authorization, and the FDA accommodated them.
The same is largely true for Moderna's SpikeVax.
Based on the descriptions and labels used for both the Pfizer/BioNTech and Moderna mRNA inoculations, both Comirnaty and SpikeVax are monovalent formulations.
The FDA has withdrawn the EUA for monovalent COVID inoculations, stating that no monovalent formulations are authorized. However, Comirnaty and SpikeVax were never "authorized" in the first place--they were "approved". Section 564 of the Food Drug and Cosmetic Act explicitly details Emergency Use Authorization as a legal mechanism applicable only to "unapproved" products (or unapproved uses of approved products). Thus the FDA announcement, strictly speaking, does not apply to Comirnaty and SpikeVax. They are still approved and could legally be administered as COVID inoculations by a healthcare professional.
If the FDA wishes to end the administration of monovalent mRNA inoculations for COVID, it technically needs to withdraw approval of Comirnaty and SpikeVax. It has not done so. Indeed, Comrinaty and SpikeVax appear to be largely forgotten within the US--forgotten by the media, forgotten by the FDA, forgotten by Big Pharma.
Comirnaty and SpikeVax are the products which nominally went through the most rigorous scrutiny. They have been largely set aside within the US.
Instead, the FDA has used the EUA mechanism to permit Pfizer/BioNTech and Moderna to bring new mRNA formulations to bear with less scrutiny and less data on both safety and efficacy. HHS Secretary Becerra has used a loophole in Section 564 to permit the FDA to continue relying on EUAs instead of the approval process even after the COVID PHE declaration expires on May 11, and has done so in a fashion which suggests there will be no recurring 90-day renewal of the authority, and thus no scrutiny or oversight by anyone, Congress in particular.
Which means Pfizer/BioNTech, Moderna, Janssen, Merck, Astra-Zeneca, and any other Big Pharma player will never need to develop COVID therapeutics which will withstand the scrutiny of the approval process. The Emergency Use Authorization has fully replaced the approval process for ALL COVID therapeutics, including those not yet developed.
Becerra's regulatory shell game is one that can be extended to any medical condition, and thus to any new therapeutic for any medical condition.
And that means the formal FDA approval process has been effectively replaced in its entirety by the EUA process. This was done unilaterally, without a regulatory hearing, without Congressional oversight, without the participation of even a single representative of We The People.
The ramifications are less about mRNA inoculations and more about the future of Big Pharma therapeutics in general. HHS and the FDA have given Big Pharma a much easier regulatory path to distributing new therapeutics. The protection against ineffective and unsafe therapeutics which the FDA approval process notionally provides has been effectively vitiated for all time.
That does not bode well for our future health and safety where Big Pharma is concerned.
You missed my main point. But first, I'm agreeing with you that the formal FDA approval process has been effectively replaced in its entirety by the EUA process. I'm only explaining that what they did is very simple trick and you don't need to read the EUA fine print. But otherwise we agree I believe.
The key thing to keep remembering is that legally Pfizer's shot is not Comirnaty.
So here is the small thing you go wrong: Pfizer did NOT opt to continue distributing the BioNTech formulation under the aegis of an Emergency Use Authorization. They continued selling their OWN formulation. These are two different products. Both legally but even product wise (even though the differences are minute and non-active) as they are made in different factories.
Once you get that, it all becomes clear.
So I'm not disputing that the FDA process as indeed been set aside and that it is a shell game. I agree! I'm just pointing out that the shell game was actually very simple. But congress now coded it into law (hidden in the December budget bill) effectively extending UEA for existing COVID-19 products for ever. New shots will need to go through full approval, reformulations (hence Pfizer+Moderna) will not.
Note, there is one more twist now we are being detailed anyway: After BioNtech got approval, about 6 months later they asked the FDA for permission for a reformulation, which changed a preservative. This was granted. But this new formulation was also never produced, imported and hence never sold/administered in the US. Instead, Pfizer also sought - legally separate - permission for the SAME reformulation for their UEA product. That was also granted, and that did get produced. Just to indicate, it wasn't just old Pfizer in-stock shots being used. They deliberately wanted to stay under UEA umbrella.
So we are in full agreement the FDA effectively replaced its formal FDA approval process, but allowing Pfizer to pretend to have FDA approval, but continuing sell under UEA.
With Moderna it is more complicated. It is not clear whether Spikevax was actually produced and sold. It may have been. It may not have been. I don't know. So it could be that their legal game was slightly less sinister. Of course their legal product will now, no longer be produced, and because the FDA no longer recommends it, any old shots remaining will surely be discarded. So all they sell is UEA too, also for them any reformulation is close to auto-approved unless the FDA gets some spine again.
Oh, there's no doubt that Pfizer and BioNTech have the world's most bizarre corporate mating dance around.
But, as you have also articulated, Pfizer is not distributing Comirnaty in the US. Globally the picture is less clear, as in places such as Malaysia the media uses "Comirnaty" as shorthand for the gamut of Pfizer/BioNTech formulations.
My great fear is less about the corruption surrounding the mRNA inoculations and more about the contagion that is being introduced into pharmaceutical regulation more broadly. The clot shots are , at this point, easily avoided for most people. Future Big Pharma concoctions may not be so easily dodged, even as the quality control mechanisms governing their manufacture are being dismantled right in front of us.
Yes and no. Coming from the medical sector, I think it is more that they do it more visibly. If you believed the full FDA approval process was rigorous, I got some bad news for you.
But first. I'm not sure of I'm reading between the lines, but my key point was that the Comirnaty trick wasn't just an artifact of their joint venture. No it was a deliberate trick to avoid legal liability. Pfizer is not distributing Comirnaty in the US, because they don't own the product. Just like Ford isn't distributing Chevy cars, despite having joint ventures in making parts.
In the EU you'd actually hence get a BioNTech shot, legally and physically. Two fun anecdotes: in the Netherlands you get BioNTech Comirnaty, even though street-name was Pfizer. In Germany you get the same BioNTech Comirnaty, but the name Pfizer was not used at all, resulting in US servicemen who wanted to get their 'green pass' were turned away at pharmacies as the person behind the computer could find the 'Pfizer' name in the dropdown list of approved vaccines. If there ever will be trials, Pfizer will have never given any approved shot, and will not be liable and people also cannot use any process associated with officially approved vaccines. The story with the preservatives shows Pfizer deliberately wanted that, and it was not an artifact of their legal structure. It was deliberately to avoid the quality control mechanisms you mention.
Moderna may not be so lucky if they were 'dumb enough' to actual produce Spikevax.
But I hate to break it to you, the actual approval process wasn't robust either, due to a trick known as the shortened procedure. That procedure in theory is great, as it allows a manufacturer to make small incremental improvements to an existing drug or vaccine, without going through the whole year-long process. Else they likely would just never do it, hurting innovation.
But this process is being abused at a structural scale. So many products with official FDA approval stamp, did not actually go through the rigorous process, but merely through something that is similar like UEA. The trick is, if you can state that your improved product is just a variant of an existing product, you only have to prove safety and effectiveness is similar.
However, the FDA allows products which are radically different to go though this process. Two examples:
1) in 2021 a new Hepatitis B 3-shot vaccine was approved based on comparison with the older 3-shot approved shot most doctors and medical professionals have taken since the 90's. The new shot however is using a completely different antigen. It is binding to different viral proteins, so any effectiveness cannot be proxied. Still it was allowed. Even worse, this old 3-shot vaccine was already superseded by a newer 2-shot vaccine that did go through full classic FDA approval in 2008. That newer 2-shot vaccine performed much better despite requiring a shot less and has distinctively less side effects. Why do you think the 2021 3-shot vaccine did not compare with the 2008 2-shot, but the older superseded one? You can guess the answer ...
2) The current Monkeypox shots. These were in fact not actually ever tested for effectiveness on Monkeypox, despite trials actually taking place in areas where monkeypox is endemic. The new Monkeypox shots are actually a smallpox vaccine, which was designed to be a safer version of the original smallpox vaccines. Safer due to the usage of the Ankara vaccina-strain that cannot multiply in the human body unlike classic smallpox strains. However, when smallpox was still around, we learned these safer strains were also far less effective against smallpox, compared to the already not very effective regular shots. So that means less than the 3-5 year protection normal shots give according to CDC data. These strains were hence rarely used, excerpt for immunocompromised people who couldn't take the normal shots, or as a primer to reduce side effects for the regular shot.
So how did it get approved. Well, as we obviously and fortunately cannot do real trials for smallpox, they were allowed to use antibodies as proxy against the original smallpox shots despite us knowing that they are likely less effective. That is fair, as these shots were primarily intended as alternative for workers who actually work with smallpox in labs and need yearly shots, and don't want the classic shots which often have severe side effects including heart damage.
But as that commercially is not interesting, the manufacturer also wanted monkeypox approval, and monkeypox is a distinct cousin so you may get some cross-protection. And because the original better shots were loosely evaluated against Monkeypox, these new ones are also approved for that without ever having to go though actual FDA full approval. A double proxy approval!
And I can give you five more recent examples.
So the bad news is, the UEA is not a break from quality control mechanisms, but merely a continuation of what was already done. Both proxy and UEA allow shortened procedures, except UEA also evades some extra legal protections. Hence, why I keep hammering on that aspect, as that is the real news IMHO. With the proxy process actual fraud would still be punishable. Under UEA even that is almost impossible.
Given that FDA approved drugs are recalled at an average pace of 2 per year, one would have to be hiding in a deep cave to have any illusions about the overall efficacy of the FDA approval process. Vioxx alone is a damnation of the state of the approval process. Adulhelm will likely become another.
Even so, the FDA approval process was still far more rigorous than the EUA process that has now effectively supplanted it.
The approval process was bad. The EUA process is several orders of magnitude worse--as will the likely damage to people's health will be as a consequence.
Line all the bastards up and let us give them the vaccines to be sure they are getting them and let us see how the issues with adverse reactions affect them not just the children.
I am tired of the rules for thee and not for me by those with no experience.
On the same day President Biden ended the EUA he funded a "faster, better mRNA for Covid"...why cant Covid be left alone and go the way of the flu? Will be interesting to see if they mandate the newly rushed "Project NextGen" Covid jabs...
It is very simple. Comirnaty is a BioNtech product, not Pfizer. That is the whole thing. Many people forget that BioNtech and Pfizer are two distinct companies, and their products are hence legally distinct. For completeness, there actually are also in terms of actual product, small differences. This as they are produced in different factories with different supply chains causing small differences in non-active ingredients.
But key is, BioNtech's Comirnaty has never been available in the US ever, except in tiny quantities imported by the military because a judge actually ruled that soldiers could not be forced to take an emergency authorized product.
So practically, Comirnaty is still approved in the US, but has never been available, and BioNtech has no plans to start importing it. So it is moot. All that ever was available here were Pfizer's product variants, and Pfizer's mono-shot is now pulled.
Spikevax is a more interesting story. Spikevax is product wise identical to the Moderna emergency authorized shot. It is however unclear how many Spikevax products were actually administered, as at time of approval there were large stocks of the emergency authorized shots. These may be physically identical, but legally not. It is hence unclear, whether anything was produced and then administered under the legal umbrella of Spikevax.
Nevertheless, Moderna could hence continue selling it today. However, as they also have moved on to the bi-valent shots, this is also moot. It will no longer be produced and hence not administered either.
If you go into get a shot today - as an adult - you'll get the emergency approved bivalent shots.
(For kids the story of course is more simple: there is nothing approved.)
Except it is not that simple.
Comirnaty is approved by the FDA (or at least, it was), regardless of whether it was actually sold or distributed in the US or not. Despite the existence of an approved product, Pfizer opted to continue distributing the BioNTech formulation under the aegis of an Emergency Use Authorization, and the FDA accommodated them.
The same is largely true for Moderna's SpikeVax.
Based on the descriptions and labels used for both the Pfizer/BioNTech and Moderna mRNA inoculations, both Comirnaty and SpikeVax are monovalent formulations.
The FDA has withdrawn the EUA for monovalent COVID inoculations, stating that no monovalent formulations are authorized. However, Comirnaty and SpikeVax were never "authorized" in the first place--they were "approved". Section 564 of the Food Drug and Cosmetic Act explicitly details Emergency Use Authorization as a legal mechanism applicable only to "unapproved" products (or unapproved uses of approved products). Thus the FDA announcement, strictly speaking, does not apply to Comirnaty and SpikeVax. They are still approved and could legally be administered as COVID inoculations by a healthcare professional.
If the FDA wishes to end the administration of monovalent mRNA inoculations for COVID, it technically needs to withdraw approval of Comirnaty and SpikeVax. It has not done so. Indeed, Comrinaty and SpikeVax appear to be largely forgotten within the US--forgotten by the media, forgotten by the FDA, forgotten by Big Pharma.
Comirnaty and SpikeVax are the products which nominally went through the most rigorous scrutiny. They have been largely set aside within the US.
Instead, the FDA has used the EUA mechanism to permit Pfizer/BioNTech and Moderna to bring new mRNA formulations to bear with less scrutiny and less data on both safety and efficacy. HHS Secretary Becerra has used a loophole in Section 564 to permit the FDA to continue relying on EUAs instead of the approval process even after the COVID PHE declaration expires on May 11, and has done so in a fashion which suggests there will be no recurring 90-day renewal of the authority, and thus no scrutiny or oversight by anyone, Congress in particular.
Which means Pfizer/BioNTech, Moderna, Janssen, Merck, Astra-Zeneca, and any other Big Pharma player will never need to develop COVID therapeutics which will withstand the scrutiny of the approval process. The Emergency Use Authorization has fully replaced the approval process for ALL COVID therapeutics, including those not yet developed.
Becerra's regulatory shell game is one that can be extended to any medical condition, and thus to any new therapeutic for any medical condition.
And that means the formal FDA approval process has been effectively replaced in its entirety by the EUA process. This was done unilaterally, without a regulatory hearing, without Congressional oversight, without the participation of even a single representative of We The People.
The ramifications are less about mRNA inoculations and more about the future of Big Pharma therapeutics in general. HHS and the FDA have given Big Pharma a much easier regulatory path to distributing new therapeutics. The protection against ineffective and unsafe therapeutics which the FDA approval process notionally provides has been effectively vitiated for all time.
That does not bode well for our future health and safety where Big Pharma is concerned.
You missed my main point. But first, I'm agreeing with you that the formal FDA approval process has been effectively replaced in its entirety by the EUA process. I'm only explaining that what they did is very simple trick and you don't need to read the EUA fine print. But otherwise we agree I believe.
The key thing to keep remembering is that legally Pfizer's shot is not Comirnaty.
So here is the small thing you go wrong: Pfizer did NOT opt to continue distributing the BioNTech formulation under the aegis of an Emergency Use Authorization. They continued selling their OWN formulation. These are two different products. Both legally but even product wise (even though the differences are minute and non-active) as they are made in different factories.
Once you get that, it all becomes clear.
So I'm not disputing that the FDA process as indeed been set aside and that it is a shell game. I agree! I'm just pointing out that the shell game was actually very simple. But congress now coded it into law (hidden in the December budget bill) effectively extending UEA for existing COVID-19 products for ever. New shots will need to go through full approval, reformulations (hence Pfizer+Moderna) will not.
Note, there is one more twist now we are being detailed anyway: After BioNtech got approval, about 6 months later they asked the FDA for permission for a reformulation, which changed a preservative. This was granted. But this new formulation was also never produced, imported and hence never sold/administered in the US. Instead, Pfizer also sought - legally separate - permission for the SAME reformulation for their UEA product. That was also granted, and that did get produced. Just to indicate, it wasn't just old Pfizer in-stock shots being used. They deliberately wanted to stay under UEA umbrella.
So we are in full agreement the FDA effectively replaced its formal FDA approval process, but allowing Pfizer to pretend to have FDA approval, but continuing sell under UEA.
With Moderna it is more complicated. It is not clear whether Spikevax was actually produced and sold. It may have been. It may not have been. I don't know. So it could be that their legal game was slightly less sinister. Of course their legal product will now, no longer be produced, and because the FDA no longer recommends it, any old shots remaining will surely be discarded. So all they sell is UEA too, also for them any reformulation is close to auto-approved unless the FDA gets some spine again.
Oh, there's no doubt that Pfizer and BioNTech have the world's most bizarre corporate mating dance around.
But, as you have also articulated, Pfizer is not distributing Comirnaty in the US. Globally the picture is less clear, as in places such as Malaysia the media uses "Comirnaty" as shorthand for the gamut of Pfizer/BioNTech formulations.
My great fear is less about the corruption surrounding the mRNA inoculations and more about the contagion that is being introduced into pharmaceutical regulation more broadly. The clot shots are , at this point, easily avoided for most people. Future Big Pharma concoctions may not be so easily dodged, even as the quality control mechanisms governing their manufacture are being dismantled right in front of us.
Yes and no. Coming from the medical sector, I think it is more that they do it more visibly. If you believed the full FDA approval process was rigorous, I got some bad news for you.
But first. I'm not sure of I'm reading between the lines, but my key point was that the Comirnaty trick wasn't just an artifact of their joint venture. No it was a deliberate trick to avoid legal liability. Pfizer is not distributing Comirnaty in the US, because they don't own the product. Just like Ford isn't distributing Chevy cars, despite having joint ventures in making parts.
In the EU you'd actually hence get a BioNTech shot, legally and physically. Two fun anecdotes: in the Netherlands you get BioNTech Comirnaty, even though street-name was Pfizer. In Germany you get the same BioNTech Comirnaty, but the name Pfizer was not used at all, resulting in US servicemen who wanted to get their 'green pass' were turned away at pharmacies as the person behind the computer could find the 'Pfizer' name in the dropdown list of approved vaccines. If there ever will be trials, Pfizer will have never given any approved shot, and will not be liable and people also cannot use any process associated with officially approved vaccines. The story with the preservatives shows Pfizer deliberately wanted that, and it was not an artifact of their legal structure. It was deliberately to avoid the quality control mechanisms you mention.
Moderna may not be so lucky if they were 'dumb enough' to actual produce Spikevax.
But I hate to break it to you, the actual approval process wasn't robust either, due to a trick known as the shortened procedure. That procedure in theory is great, as it allows a manufacturer to make small incremental improvements to an existing drug or vaccine, without going through the whole year-long process. Else they likely would just never do it, hurting innovation.
But this process is being abused at a structural scale. So many products with official FDA approval stamp, did not actually go through the rigorous process, but merely through something that is similar like UEA. The trick is, if you can state that your improved product is just a variant of an existing product, you only have to prove safety and effectiveness is similar.
However, the FDA allows products which are radically different to go though this process. Two examples:
1) in 2021 a new Hepatitis B 3-shot vaccine was approved based on comparison with the older 3-shot approved shot most doctors and medical professionals have taken since the 90's. The new shot however is using a completely different antigen. It is binding to different viral proteins, so any effectiveness cannot be proxied. Still it was allowed. Even worse, this old 3-shot vaccine was already superseded by a newer 2-shot vaccine that did go through full classic FDA approval in 2008. That newer 2-shot vaccine performed much better despite requiring a shot less and has distinctively less side effects. Why do you think the 2021 3-shot vaccine did not compare with the 2008 2-shot, but the older superseded one? You can guess the answer ...
2) The current Monkeypox shots. These were in fact not actually ever tested for effectiveness on Monkeypox, despite trials actually taking place in areas where monkeypox is endemic. The new Monkeypox shots are actually a smallpox vaccine, which was designed to be a safer version of the original smallpox vaccines. Safer due to the usage of the Ankara vaccina-strain that cannot multiply in the human body unlike classic smallpox strains. However, when smallpox was still around, we learned these safer strains were also far less effective against smallpox, compared to the already not very effective regular shots. So that means less than the 3-5 year protection normal shots give according to CDC data. These strains were hence rarely used, excerpt for immunocompromised people who couldn't take the normal shots, or as a primer to reduce side effects for the regular shot.
So how did it get approved. Well, as we obviously and fortunately cannot do real trials for smallpox, they were allowed to use antibodies as proxy against the original smallpox shots despite us knowing that they are likely less effective. That is fair, as these shots were primarily intended as alternative for workers who actually work with smallpox in labs and need yearly shots, and don't want the classic shots which often have severe side effects including heart damage.
But as that commercially is not interesting, the manufacturer also wanted monkeypox approval, and monkeypox is a distinct cousin so you may get some cross-protection. And because the original better shots were loosely evaluated against Monkeypox, these new ones are also approved for that without ever having to go though actual FDA full approval. A double proxy approval!
And I can give you five more recent examples.
So the bad news is, the UEA is not a break from quality control mechanisms, but merely a continuation of what was already done. Both proxy and UEA allow shortened procedures, except UEA also evades some extra legal protections. Hence, why I keep hammering on that aspect, as that is the real news IMHO. With the proxy process actual fraud would still be punishable. Under UEA even that is almost impossible.
Given that FDA approved drugs are recalled at an average pace of 2 per year, one would have to be hiding in a deep cave to have any illusions about the overall efficacy of the FDA approval process. Vioxx alone is a damnation of the state of the approval process. Adulhelm will likely become another.
Even so, the FDA approval process was still far more rigorous than the EUA process that has now effectively supplanted it.
The approval process was bad. The EUA process is several orders of magnitude worse--as will the likely damage to people's health will be as a consequence.
It's not a good trend.
Excellent analysis. I have been waiting to post something about this and I will feature this article in my post.
Thank you for your kind words and for featuring my article!
Good article and good catch, Peter. Linking today @https://nothingnewunderthesun2016.com/
Last summer I described the HHS emergency declaration power as an "enabling act" for pharmaceutical authoritarianism.
https://newsletter.allfactsmatter.us/p/covid-19-the-endless-emergency
Secretary Becerra is proving me correct.
.
Dear Heavily Vaccinated,
I Am Old Enough To Remember,
When Comedy
Was Supposed To Be Funny.
.
Line all the bastards up and let us give them the vaccines to be sure they are getting them and let us see how the issues with adverse reactions affect them not just the children.
I am tired of the rules for thee and not for me by those with no experience.
"That government is best which governs not at all." -- Henry David Thoreau.
We are living the proof of this.
How funny you quoted HDT, I've been rereading Civil Disobedience.
He's one of my favorites.
Mine too, along with Thomas Paine.
Excellent!!!!
Wow. Something is going on.
Yes, and they are such WEASELS!
Lawsuits must be pursued relentlessly. They must not be allowed to continue to harm everyone!
Definitely want to see a lawsuit over the EUAs. Becerra has basically rewritten the key portions of the FD&C Act.
Someway somehow SCOTUS needs to weigh in here.
On the same day President Biden ended the EUA he funded a "faster, better mRNA for Covid"...why cant Covid be left alone and go the way of the flu? Will be interesting to see if they mandate the newly rushed "Project NextGen" Covid jabs...
https://www.reuters.com/business/healthcare-pharmaceuticals/us-spending-5-billion-speed-up-development-new-covid-vaccines-2023-04-10/