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No, that is incorrect. The FDA Only renewed emergency use authorization for Pfizer; Approval was for BioNTech’s Comirnaty with additional safety studies require

No, that is incorrect. The FDA Only renewed emergency use authorization for Pfizer; Approval was for BioNTech’s Comirnaty with additional safety studies required (until 2027). It's currently not available in the US.

ceejayoz 5y ago
False. https://www.reuters.com/article/factcheck-fda-pfizer/fact-check-media-reports-have-not-lied-about-pfizer-biontechs-fda-approval-idUSL1N2PY0OL https://www.reuters.com/article/factcheck-fda-pfizer/fact-ch... > The FDA state that Comirnaty has the same formulation as the EUA-approved (Emergency Use Authorization) Pfizer vaccine and is interchangeable (here). Their website says: “Providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed dose.” (here).
- guilhas 5y ago
  "Reuters is seeking comment on the legal specificities of the FDA approval and will update the check in due course." How convenient. Pfizer states that both vaccines are legally different. Meaning even with the same formula 'Pfizer' vaccine has no liability for compensation claims, 'Comirnaty' has but it is not being supplied
  - ceejayoz 5y ago
    "I can't be bothered to Google" and "convenient" aren't quite the same thing. The information you seek is readily available. The two have the exact same liability setup. 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... > “There are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval,” confirmed an HHS spokesperson. Pfizer also has a more specific comment on the legal specifics in this article: > “The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”
    - guilhas 5y ago
      "The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits. ... The liability protections afforded under the PREP Act are tied to the declared public health emergency and not whether the vaccine is sold under an EUA" OK... because of the "state of emergency" there is actually no compensations for either the vaccines I feel so much safer
      - ceejayoz 5y ago
        Can you explain why you think the “Countermeasures Injury COMPENSATION Program” doesn’t include compensation?
        guilhas 5y ago
        They say in the same article, 0 have been compensated from the 600 that already applied Also the the PREP Act states that liability is limited so only very special cases will be compensated under "pandemic state of emergency" It is a bit like "Democratic Republic of North Korea", being in the name doesn't actually have to mean it
spear 5y ago
It's the same thing -- Comirnaty is the brand name of the Pfizer/BioNTech COVID vaccine.
- dukeofdoom 5y ago
  I'm not sure if that's the case legally. Is windows 11 same as windows 10, since both are a type of windows released by the same company. Let's say there's a security feature that works the same in both versions. But in windows 11 it was certified to work. I don't think you could sue effectively it failed in your installation of windows 10. MS could just say you should had no expectation for it to work because it wasn't certified to work at that time when you purchased your product. In fact the lack of certification necessarily implies that you used the feature at your own risk, and take full liability

ceejayoz 5y ago

False. https://www.reuters.com/article/factcheck-fda-pfizer/fact-check-media-reports-have-not-lied-about-pfizer-biontechs-fda-approval-idUSL1N2PY0OL https://www.reuters.com/article/factcheck-fda-pfizer/fact-ch... > The FDA state that Comirnaty has the same formulation as the EUA-approved (Emergency Use Authorization) Pfizer vaccine and is interchangeable (here). Their website says: “Providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed dose.” (here).

guilhas 5y ago
"Reuters is seeking comment on the legal specificities of the FDA approval and will update the check in due course." How convenient. Pfizer states that both vaccines are legally different. Meaning even with the same formula 'Pfizer' vaccine has no liability for compensation claims, 'Comirnaty' has but it is not being supplied
- ceejayoz 5y ago
  "I can't be bothered to Google" and "convenient" aren't quite the same thing. The information you seek is readily available. The two have the exact same liability setup. 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... > “There are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval,” confirmed an HHS spokesperson. Pfizer also has a more specific comment on the legal specifics in this article: > “The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”
  - guilhas 5y ago
    "The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits. ... The liability protections afforded under the PREP Act are tied to the declared public health emergency and not whether the vaccine is sold under an EUA" OK... because of the "state of emergency" there is actually no compensations for either the vaccines I feel so much safer
    - ceejayoz 5y ago
      Can you explain why you think the “Countermeasures Injury COMPENSATION Program” doesn’t include compensation?
      - guilhas 5y ago
        They say in the same article, 0 have been compensated from the 600 that already applied Also the the PREP Act states that liability is limited so only very special cases will be compensated under "pandemic state of emergency" It is a bit like "Democratic Republic of North Korea", being in the name doesn't actually have to mean it

spear 5y ago

It's the same thing -- Comirnaty is the brand name of the Pfizer/BioNTech COVID vaccine.

dukeofdoom 5y ago
I'm not sure if that's the case legally. Is windows 11 same as windows 10, since both are a type of windows released by the same company. Let's say there's a security feature that works the same in both versions. But in windows 11 it was certified to work. I don't think you could sue effectively it failed in your installation of windows 10. MS could just say you should had no expectation for it to work because it wasn't certified to work at that time when you purchased your product. In fact the lack of certification necessarily implies that you used the feature at your own risk, and take full liability