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https://www.americanthinker.com/articles/2022/02/fda_duplicity_on_covid19_vaccines.html
In August of 2021, the FDA, to great media fanfare, granted permanent approval for a Pfizer Covid-19 vaccine. The catch: it was for a vaccine that was not available to Americans. What the FDA approved and licensed is Pfizer’s Comirnaty vaccine, not the Pfizer-BioNTech vaccine that has been continuously in use under Emergency Use Authorization (EUA) since December of 2020. Manufacturers of medicines sold under an EUA are immunized from legal liability.
The FDA decreed that the Pfizer-BioNTech vaccine should remain unlicensed and under the EUA but can be used interchangeably with the licensed Comirnaty vaccine. More importantly, the FDA stated that the Comirnaty vaccine and the existing vaccine are “legally distinct” and that there are slight differences in the vaccines, though their differences “do not impact safety or effectiveness.”
...
Moreover, the FDA acknowledged that there was no inventory of the Comirnaty vaccine available. Nearly six months later there is still no inventory available and will not be in the foreseeable future. Every vaccination with a Pfizer covid vaccine has been and continues to be with the one under the EUA.
...
EUA products are considered experimental under U.S. law. Federal regulations provide that no one can force a person to participate in being jabbed with an experimental vaccine-- 21 U.S. Code Sec.360bbb-3(e)(1)(A) “Authorization For Medical Products For Use In Emergencies.” Potential recipients have an absolute right to refuse EUA vaccines nor can they be denied a job or an education because they refuse to be vaccinated. However, U.S. law permits employers, schools, and government agencies to require employees and students to take licensed vaccines.
Pfizer and Moderna together with the FDA continue to seek a more permanent solution to the liability question as at some point they will no longer be able to rely on legal hairsplitting and will have to use the Comirnaty and Spikevax labeled products. The potential solution: The National Childhood Vaccine Injury Act (NCVIA).
This law, passed in 1986, provides a legal liability shield to drug manufacturers if they secure full FDA approval for all age groups. According to Steve Kirsch, Pfizer is clandestinely working with the FDA and altering the ingredients (which normally requires a new and separate filing and licensing process) to clear the path for approval.
When Comirnaty and Spikevax are approved for children, then the companies will have definitive government-sponsored liability protection if and when their shaky argument that the original EUA approvals extend to these two products is rendered moot. Pfizer and Moderna are apparently waiting for full authorization for children’s shots before they distribute Comirnaty and Spikevax to the masses.
https://www.americanthinker.com/articles/2022/02/fda_duplicity_on_covid19_vaccines.html
In August of 2021, the FDA, to great media fanfare, granted permanent approval for a Pfizer Covid-19 vaccine. The catch: it was for a vaccine that was not available to Americans. What the FDA approved and licensed is Pfizer’s Comirnaty vaccine, not the Pfizer-BioNTech vaccine that has been continuously in use under Emergency Use Authorization (EUA) since December of 2020. Manufacturers of medicines sold under an EUA are immunized from legal liability.
The FDA decreed that the Pfizer-BioNTech vaccine should remain unlicensed and under the EUA but can be used interchangeably with the licensed Comirnaty vaccine. More importantly, the FDA stated that the Comirnaty vaccine and the existing vaccine are “legally distinct” and that there are slight differences in the vaccines, though their differences “do not impact safety or effectiveness.”
...
Moreover, the FDA acknowledged that there was no inventory of the Comirnaty vaccine available. Nearly six months later there is still no inventory available and will not be in the foreseeable future. Every vaccination with a Pfizer covid vaccine has been and continues to be with the one under the EUA.
...
EUA products are considered experimental under U.S. law. Federal regulations provide that no one can force a person to participate in being jabbed with an experimental vaccine-- 21 U.S. Code Sec.360bbb-3(e)(1)(A) “Authorization For Medical Products For Use In Emergencies.” Potential recipients have an absolute right to refuse EUA vaccines nor can they be denied a job or an education because they refuse to be vaccinated. However, U.S. law permits employers, schools, and government agencies to require employees and students to take licensed vaccines.
Pfizer and Moderna together with the FDA continue to seek a more permanent solution to the liability question as at some point they will no longer be able to rely on legal hairsplitting and will have to use the Comirnaty and Spikevax labeled products. The potential solution: The National Childhood Vaccine Injury Act (NCVIA).
This law, passed in 1986, provides a legal liability shield to drug manufacturers if they secure full FDA approval for all age groups. According to Steve Kirsch, Pfizer is clandestinely working with the FDA and altering the ingredients (which normally requires a new and separate filing and licensing process) to clear the path for approval.
When Comirnaty and Spikevax are approved for children, then the companies will have definitive government-sponsored liability protection if and when their shaky argument that the original EUA approvals extend to these two products is rendered moot. Pfizer and Moderna are apparently waiting for full authorization for children’s shots before they distribute Comirnaty and Spikevax to the masses.