5 ms·

My random guess which should be taken with a grain of salt is there is some kind of workaround based on the fact that the original vaccine and this are both und

My random guess which should be taken with a grain of salt is there is some kind of workaround based on the fact that the original vaccine and this are both under the EUA. Context info: FDA approved one of the original vaccines (Pfizer I think?) but the approved version has never hit the market because the approved version comes with liability. Literally no one has access to the approved vaccine, only the EUA one. If the EUA version harms/kills you then you can't sue anyone.

ok_dad 4y ago
Both Pfizer[0] and Moderna[1] vaccines are full-approved, so your "context info" is absolutely false. [0] - https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines https://www.fda.gov/emergency-preparedness-and-response/coro... [1] - https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines https://www.fda.gov/emergency-preparedness-and-response/coro...
- Consultant32452 4y ago
  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.

ok_dad 4y ago

Both Pfizer[0] and Moderna[1] vaccines are full-approved, so your "context info" is absolutely false. [0] - https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines https://www.fda.gov/emergency-preparedness-and-response/coro... [1] - https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines https://www.fda.gov/emergency-preparedness-and-response/coro...

Consultant32452 4y ago
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.