"Comirnaty has FDA approval, but isn't yet mandated for children so it currently has liability in case of disability or death. Pfizer isn't distributing Comirnaty."
Not true i think. they ALL have liability waivers
"Comirnaty has FDA approval, but isn't yet mandated for children so it currently has liability in case of disability or death. Pfizer isn't distributing Comirnaty."
I'm not sure. The FDA authorization for Comirnaty stated that the Pfizer current vaccines and Comirnaty have the same ingredients and are basically the same vaccine. However, "the products are legally distinct with certain differences that do not impact safety or effectiveness." This is a quote from the FDA authorization.
There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.
EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
…At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.
But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.
And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
“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.”
The representative also told Heavy that the manufacturing process is the same. The products with the EUA authorized label will still be used until their expiration date, if storage conditions are followed.When Comirnaty received full FDA approval, the FDA noted in a press release: “The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty… for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
The existing EUA Pfizer vaccines have a liability shield which means that everyone involved with the product is protected from being sued. People who take a EUA vaccine and end up suffering injuries can only obtain compensation after applying to the Countermeasures Injury Compensation Program (CICP). The program has only awarded compensation to three percent of the claims made. On the other hand, people have the right to not take the vaccine. For instance, no business can force employees to take EUA vaccine injections. This right is protected under federal laws. Comirnaty is not yet available in the U.S.
There is a lawsuit stating that EUA should be withdrawn since Comirnaty has FDA approval.The law cited in the suit is 21 U.S. Code § 360bbb–3 which concerns “Authorization for medical products for use in emergencies.” The code states that a EUA designation must only be used when there is no “approved” alternative for preventing or treating the specific disease. Granting approval to Comirnaty should naturally make the EUA licenses of existing Pfizer vaccines void. In addition, the EUA status for other COVID-19 vaccines should also not be preserved.
Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
Comirnaty has FDA approval, so vaccine mandates for Comirnaty can be imposed. The current mRNA vaccine does not have FDA approval, so it cannot be mandated.
Comirnaty is NOT on the mandated childhood vaccination schedule, so it isn't fully shielded from liability.
"Comirnaty has FDA approval, but isn't yet mandated for children so it currently has liability in case of disability or death. Pfizer isn't distributing Comirnaty."
Not true i think. they ALL have liability waivers
I'm not sure. The FDA authorization for Comirnaty stated that the Pfizer current vaccines and Comirnaty have the same ingredients and are basically the same vaccine. However, "the products are legally distinct with certain differences that do not impact safety or effectiveness." This is a quote from the FDA authorization.
There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.
Comirnaty is available in Europe, but not in U.S.
https://www.educationviews.org/fdas-shell-game-pfizer-jab-not-approved-after-all/
EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
…At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.
But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.
And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
"At least for the moment, the Pfizer Comirnaty vaccine has no liability shield"
that is not true
Can you provide a url link to show that Comirnaty has a liability shield? My research shows that drugs for adults don't have this shield.
“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.”
Then what is the point of them distinguishing so carefully between the names of the approved and not approved?
So the FDA states the 2 different vaccines have "some legal differences." Do you know what the differences are?
No
i dont think anyone does. some are asking but no answers so far
I tried to find out by using a search engine. I got these "answers."
https://heavy.com/news/comirnaty-vs-pfizer-vaccine-legally-distinct/
The representative also told Heavy that the manufacturing process is the same. The products with the EUA authorized label will still be used until their expiration date, if storage conditions are followed.When Comirnaty received full FDA approval, the FDA noted in a press release: “The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty… for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
https://www.visiontimes.com/2021/09/09/why-the-fdas-pfizer-vaccine-approval-is-controversial-disingenuous-and-facing-a-lawsuit.html
The existing EUA Pfizer vaccines have a liability shield which means that everyone involved with the product is protected from being sued. People who take a EUA vaccine and end up suffering injuries can only obtain compensation after applying to the Countermeasures Injury Compensation Program (CICP). The program has only awarded compensation to three percent of the claims made. On the other hand, people have the right to not take the vaccine. For instance, no business can force employees to take EUA vaccine injections. This right is protected under federal laws. Comirnaty is not yet available in the U.S.
There is a lawsuit stating that EUA should be withdrawn since Comirnaty has FDA approval.The law cited in the suit is 21 U.S. Code § 360bbb–3 which concerns “Authorization for medical products for use in emergencies.” The code states that a EUA designation must only be used when there is no “approved” alternative for preventing or treating the specific disease. Granting approval to Comirnaty should naturally make the EUA licenses of existing Pfizer vaccines void. In addition, the EUA status for other COVID-19 vaccines should also not be preserved.
https://stuartbramhall.wordpress.com/2021/08/24/two-things-mainstream-media-didnt-tell-you-about-fdas-approval-of-pfizer-vaccine/
Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
Comirnaty has FDA approval, so vaccine mandates for Comirnaty can be imposed. The current mRNA vaccine does not have FDA approval, so it cannot be mandated.
Comirnaty is NOT on the mandated childhood vaccination schedule, so it isn't fully shielded from liability.