4 ms·

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

by wrl 4y ago

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?

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

by 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?