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The approved versions of the vaccine are not actually being distributed, at least as of a few months ago. Your own FDA article differentiates them. >The vaccin

The approved versions of the vaccine are not actually being distributed, at least as of a few months ago. Your own FDA article differentiates them. >The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older. The Pfizer-BioNTech version is different than the Comirnaty version. Even if the difference is just the label, we have no way of knowing. The difference is likely the difference between name brand and generic. There's no reason, as far as I know, to believe there's any difference in efficacy or safety. However, the one that is being distributed is still the Pfizer-BioNTech version because that one carries liability immunity for Pfizer due to the EUA. They would be foolish to produce and distribute the approved version. I believe the prevailing narrative that the vaccines are safe enough and effective enough to use.

wrl 4y ago
> The Pfizer-BioNTech version is different than the Comirnaty version. How do they differ? Aren't they both tozinameran?
- Consultant32452 4y ago
  As I stated in my comment, the difference may only be the label. But the FDA article clearly differentiates them and explicitly discusses how the approvals vs EUA are different for each.
  - google234123 4y ago
    They are the same. Changing the name of something doesn’t mean anything substantial. https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different https://www.nebraskamed.com/COVID/you-asked-we-answered-are-...
    - incrudible 4y ago
      From your source: The products are legally distinct with certain differences that do not impact safety or effectiveness I for one do care about legal distinctions. So, what are these differences?
      - google234123 4y ago
        From: https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download "The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.35 35 Analytical comparability assessments use laboratory testing to demonstrate that a change in product formulation does not impact a product's safety or effectiveness. For the Pfizer-BioNTech COVID-19 Vaccine, multiple different release parameters were evaluated to assess the comparability of the modified formulation (the formulation with the Tris buffer) to the originally-authorized formulation (the formulation with the PBS buffer). These release parameters ranged from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the product. Release and characterization tests include tests for purity, composition, and critical attributes of mRNA associated with the activity of the vaccine. The combination of release testing and characterization testing demonstrated that the modified formulation is analytically comparable to the original formulation." Changing one buffer to another (to keep the vaccine at a similar pH to the body) isn't likely to have any active effect.
        incrudible 4y ago
        Advil and Motrin are two products with differences in inactive ingredients that are analytically comparable. They are however legally distinct. If Motrin slips on QC, you don't get to sue the manufacturer of Advil. So, what are the legal distinctions? Is this legally distinct product actually available and what are the distinctions, for instance, regarding liabilities?
jltsiren 4y ago
At least in the EU, the vaccine that was approved in December 2020 was already called Comirnaty.
- Consultant32452 4y ago
  I'm less familiar with EU liability laws. In the US the FDA differentiates an EUA version and the regular FDA approved version. The difference may only be the label, but Pfizer would be foolish to distribute a version with liability attached when they could distribute a version without liability attached. Are you familiar enough with EU drug liability laws to speak to whether Pfizer has any liability? I hate having these autistic fine detail discussions in this context because people assume I'm anti-vax. I will state here again I believe the vaccines are safe enough and effective enough to justify use.
bb88 4y ago
> The Pfizer-BioNTech version is different than the Comirnaty version. You haven't proved this to be the case. It seems like fearmongering to me. It's "marketed" differently, not "formulated" differently.
- Consultant32452 4y ago
  They are approved differently, as is detailed further in the article. I already stated the difference may just be the label. Or perhaps like the difference between name brand and generic. I explicitly stated there's no reason to believe there's any difference in safety or efficacy. My commentary is about skirting liability laws, not efficacy or safety.
  - bb88 4y ago
    Again, you haven't proved it. Just more fearmongering.
    - Happos 4y ago
      Pfizer themselves prove it for him (https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download, Page 18): “The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.” They go on to explain that the modified formulation uses a different buffer. He is correct at least regarding a formulation difference.
      - bb88 4y ago
        Okay, now the next issue is whether or not they're withholding Comirnaty from the US Market. Again, no proof of this. Just speculation and fearmongering. Further they have to show that have potential legal exposure from a fully approved vaccine over an EUA. From my understanding of the PREP [1] act, Alex Azar declared a public health emergency in 2020. The PREP act gives immunity for all medical companies working on Covid 19 treatments until 2024. [1] https://crsreports.congress.gov/product/pdf/LSB/LSB10443 https://crsreports.congress.gov/product/pdf/LSB/LSB10443
mint2 4y ago
Edit: I did the OPs homework. The claim about a legal liability difference is false per https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/ https://www.washingtonpost.com/politics/2021/08/30/false-cla.... In fact both the eua and fully approved version have the same protection due to the PREP act. OP please stop spreading false rumors that originated on Steve bannons war room. Now that you know the rumors you posted are false it would be appreciated if you go back to wherever you’ve posted the wrong info and post updates indicating the mistake. Original post: Please provide a citation for saying the fda approved version is not being distributed because it seems highly illogical that the full approval wouldn’t supersede the eua, with all the legal entailing implications, and the eua would cease to be valid. The fda has done some odd things in the past but a citation is needed on that claim that the approved version is not distributed and that both approvals coexist rather then the eua is superceded.
joshuamorton 4y ago
According to vaccines.gov, I can get COMIRNATY at a number of drugstores near by. There are subtleties around the precise vaccine series, in that the FDA approved, and COMIRNATY marketed thing is precisely a two dose series for people 12 and up, and there are a bunch of places where only the EUA applies (a three dose, non-booster series for immunocompromised folks, anything for kids 4-12 years old, etc.). Your claim about the EUA appears to be wholly unfounded, as I don't think there are significant liability differences between an EUA and full FDA approval anyway (you get limited liability with FDA approval normally, the National Vaccine Injury Compensation Program existed pre Covid-19). And there's tons of resources that trivially confirm that the vaccines are identical and that you can even get half COMIRNATY and half not, which makes the whole liability argument even less legitimate looking.
Izkata 4y ago
> Even if the difference is just the label, we have no way of knowing. They actually said in the approval document that they're not the same, there were changes to inactive ingredients (to improve shelf life IIRC).

wrl 4y ago

> The Pfizer-BioNTech version is different than the Comirnaty version. How do they differ? Aren't they both tozinameran?

Consultant32452 4y ago
As I stated in my comment, the difference may only be the label. But the FDA article clearly differentiates them and explicitly discusses how the approvals vs EUA are different for each.
- google234123 4y ago
  They are the same. Changing the name of something doesn’t mean anything substantial. https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different https://www.nebraskamed.com/COVID/you-asked-we-answered-are-...
  - incrudible 4y ago
    From your source: The products are legally distinct with certain differences that do not impact safety or effectiveness I for one do care about legal distinctions. So, what are these differences?
    - google234123 4y ago
      From: https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download "The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.35 35 Analytical comparability assessments use laboratory testing to demonstrate that a change in product formulation does not impact a product's safety or effectiveness. For the Pfizer-BioNTech COVID-19 Vaccine, multiple different release parameters were evaluated to assess the comparability of the modified formulation (the formulation with the Tris buffer) to the originally-authorized formulation (the formulation with the PBS buffer). These release parameters ranged from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the product. Release and characterization tests include tests for purity, composition, and critical attributes of mRNA associated with the activity of the vaccine. The combination of release testing and characterization testing demonstrated that the modified formulation is analytically comparable to the original formulation." Changing one buffer to another (to keep the vaccine at a similar pH to the body) isn't likely to have any active effect.
      - incrudible 4y ago
        Advil and Motrin are two products with differences in inactive ingredients that are analytically comparable. They are however legally distinct. If Motrin slips on QC, you don't get to sue the manufacturer of Advil. So, what are the legal distinctions? Is this legally distinct product actually available and what are the distinctions, for instance, regarding liabilities?

jltsiren 4y ago

At least in the EU, the vaccine that was approved in December 2020 was already called Comirnaty.

Consultant32452 4y ago
I'm less familiar with EU liability laws. In the US the FDA differentiates an EUA version and the regular FDA approved version. The difference may only be the label, but Pfizer would be foolish to distribute a version with liability attached when they could distribute a version without liability attached. Are you familiar enough with EU drug liability laws to speak to whether Pfizer has any liability? I hate having these autistic fine detail discussions in this context because people assume I'm anti-vax. I will state here again I believe the vaccines are safe enough and effective enough to justify use.

bb88 4y ago

> The Pfizer-BioNTech version is different than the Comirnaty version. You haven't proved this to be the case. It seems like fearmongering to me. It's "marketed" differently, not "formulated" differently.

Consultant32452 4y ago
They are approved differently, as is detailed further in the article. I already stated the difference may just be the label. Or perhaps like the difference between name brand and generic. I explicitly stated there's no reason to believe there's any difference in safety or efficacy. My commentary is about skirting liability laws, not efficacy or safety.
- bb88 4y ago
  Again, you haven't proved it. Just more fearmongering.
  - Happos 4y ago
    Pfizer themselves prove it for him (https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download, Page 18): “The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.” They go on to explain that the modified formulation uses a different buffer. He is correct at least regarding a formulation difference.
    - bb88 4y ago
      Okay, now the next issue is whether or not they're withholding Comirnaty from the US Market. Again, no proof of this. Just speculation and fearmongering. Further they have to show that have potential legal exposure from a fully approved vaccine over an EUA. From my understanding of the PREP [1] act, Alex Azar declared a public health emergency in 2020. The PREP act gives immunity for all medical companies working on Covid 19 treatments until 2024. [1] https://crsreports.congress.gov/product/pdf/LSB/LSB10443 https://crsreports.congress.gov/product/pdf/LSB/LSB10443

mint2 4y ago

Edit: I did the OPs homework. The claim about a legal liability difference is false per https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/ https://www.washingtonpost.com/politics/2021/08/30/false-cla.... In fact both the eua and fully approved version have the same protection due to the PREP act. OP please stop spreading false rumors that originated on Steve bannons war room. Now that you know the rumors you posted are false it would be appreciated if you go back to wherever you’ve posted the wrong info and post updates indicating the mistake. Original post: Please provide a citation for saying the fda approved version is not being distributed because it seems highly illogical that the full approval wouldn’t supersede the eua, with all the legal entailing implications, and the eua would cease to be valid. The fda has done some odd things in the past but a citation is needed on that claim that the approved version is not distributed and that both approvals coexist rather then the eua is superceded.

joshuamorton 4y ago

According to vaccines.gov, I can get COMIRNATY at a number of drugstores near by. There are subtleties around the precise vaccine series, in that the FDA approved, and COMIRNATY marketed thing is precisely a two dose series for people 12 and up, and there are a bunch of places where only the EUA applies (a three dose, non-booster series for immunocompromised folks, anything for kids 4-12 years old, etc.). Your claim about the EUA appears to be wholly unfounded, as I don't think there are significant liability differences between an EUA and full FDA approval anyway (you get limited liability with FDA approval normally, the National Vaccine Injury Compensation Program existed pre Covid-19). And there's tons of resources that trivially confirm that the vaccines are identical and that you can even get half COMIRNATY and half not, which makes the whole liability argument even less legitimate looking.

Izkata 4y ago

> Even if the difference is just the label, we have no way of knowing. They actually said in the approval document that they're not the same, there were changes to inactive ingredients (to improve shelf life IIRC).