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The language still seems slippery because while the formulation may be the same and interchangeable for providers, the legal process bound to the license could

The language still seems slippery because while the formulation may be the same and interchangeable for providers, the legal process bound to the license could be different for the recipient. If the PREP Act still applies, then there’s less recourse for anyone that may experience an adverse reaction.

ceejayoz 5y ago
No change there. Same recourse for both. https://www.jdsupra.com/legalnews/fda-approval-of-pfizer-vaccine-4137133/ https://www.jdsupra.com/legalnews/fda-approval-of-pfizer-vac... > Does PREP Act liability protection extend to Comirnaty? > Yes. The government invoked the PREP Act in response to the COVID-19 pandemic. Under the terms of that act, "covered persons" are granted certain immunity from liability for activities related to "covered countermeasures." Covered persons include essentially all of the entities involved in the manufacture, distribution, and administration of the countermeasure. The term "covered countermeasures" includes both approved COVID-19 products, as well as unapproved products used under an EUA. The Comirnaty approval does not change the status of the vaccine as a covered countermeasure under the PREP Act, and the approved vaccine should receive equal liability protection compared to the version of the vaccine used under the EUA. 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... > “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.” > Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act). > “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,” Castillo said. “Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19.”
- programmarchy 5y ago
  Ah, even worse than I expected. I should've known. It's funny how they triumphantly phrase it as a good thing that the public should take on all of the risk, while the most powerful take on virtually none. Furthermore, there's now an enormous incentive to lobby for never ceasing the public health emergency, since at that point they'd lose their enhanced liability protection.
  - throwawaylinux 5y ago
    Socialize risk, privatize profit. Standard MO for the corrupt corporate-political regime.

ceejayoz 5y ago

No change there. Same recourse for both. https://www.jdsupra.com/legalnews/fda-approval-of-pfizer-vaccine-4137133/ https://www.jdsupra.com/legalnews/fda-approval-of-pfizer-vac... > Does PREP Act liability protection extend to Comirnaty? > Yes. The government invoked the PREP Act in response to the COVID-19 pandemic. Under the terms of that act, "covered persons" are granted certain immunity from liability for activities related to "covered countermeasures." Covered persons include essentially all of the entities involved in the manufacture, distribution, and administration of the countermeasure. The term "covered countermeasures" includes both approved COVID-19 products, as well as unapproved products used under an EUA. The Comirnaty approval does not change the status of the vaccine as a covered countermeasure under the PREP Act, and the approved vaccine should receive equal liability protection compared to the version of the vaccine used under the EUA. 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... > “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.” > Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act). > “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,” Castillo said. “Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19.”

programmarchy 5y ago
Ah, even worse than I expected. I should've known. It's funny how they triumphantly phrase it as a good thing that the public should take on all of the risk, while the most powerful take on virtually none. Furthermore, there's now an enormous incentive to lobby for never ceasing the public health emergency, since at that point they'd lose their enhanced liability protection.
- throwawaylinux 5y ago
  Socialize risk, privatize profit. Standard MO for the corrupt corporate-political regime.