3 ms·

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 bet

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
    - Happos 4y ago
      I didn’t read fearmongering from OP’s comments, just speculation. I have no idea about the liability issue. The more interesting one to me was the government vaccine mandates last year (medical vs legal interchangeability, eua vs approved). Interestingly, according to Pfizer the 08/23/2021 originally approved Comirnaty formulation (PBS buffer) was never available: “… These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced” (https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-c...). The updated Tris buffer Comirnaty formulation was FDA approved on 10/29/2021 (https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download, Page 8). As for if its available, I guess you would have to go check a few pharmacies and ask if the Pfizer vaccine they have is labeled ‘Comirnaty.’ Some articles from the end of last year say they couldn’t find it, but who knows now. I have not looked into this at all, and to be honest I’ve already spent too much time searching this stuff up today so I’ll leave that for another person.

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
  - Happos 4y ago
    I didn’t read fearmongering from OP’s comments, just speculation. I have no idea about the liability issue. The more interesting one to me was the government vaccine mandates last year (medical vs legal interchangeability, eua vs approved). Interestingly, according to Pfizer the 08/23/2021 originally approved Comirnaty formulation (PBS buffer) was never available: “… These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced” (https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-c...). The updated Tris buffer Comirnaty formulation was FDA approved on 10/29/2021 (https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download, Page 8). As for if its available, I guess you would have to go check a few pharmacies and ask if the Pfizer vaccine they have is labeled ‘Comirnaty.’ Some articles from the end of last year say they couldn’t find it, but who knows now. I have not looked into this at all, and to be honest I’ve already spent too much time searching this stuff up today so I’ll leave that for another person.