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Vaccinated People Spread The Delta Variant, CDC Says
(09-15-2021, 09:25 PM)kalakoa Wrote: It really cant be any more clear. Its right there in the authorization letter.

Read carefully: FDA granted full approval for individuals 16 years of age and older, while also leaving the EUA in place for ages 12-15 and extending the EUA to allow a third (booster) shot.

Disclaimer: I do not work for Fox News.
They approved theĀ  BioNTech Manufacturing GmbH for COMIRNATY. They extended the EUA for Pfizer. with a footnote that says.
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used

interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The
products are legally distinct with certain differences that do not impact safety or effectiveness.


Somewhere the, "and certain differences" though "the same formulation" make all the difference in pfizer not getting their BLA. Two different entities two vaccines, one approved one not. It is interesting to note that the BLA authorization on the German product requires long term studies until 2027.

It further supports the emergency authorization of Phizer in footnote 9.
9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years

of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at

the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in

individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised
population described in this EUA.

Re issuance of an EUA is not full approval. Clearly the fda is trying to cya with this non approval approval letter. And had anyone actually looked up Section 564 of the code like anyone(news, media etc) would realize that when they say authorized pursuant to. It is Emergency Use Authorization.

https://astho.org/Programs/Preparedness/...act-Sheet/


Its still black and white even if its bait and switch. The best part is an EUA protects Pfizer from liability. Why would Pfizer want to give up that sweet deal. they dont.


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RE: Vaccinated People Spread The Delta Variant, CDC Says - by kander - 09-15-2021, 10:21 PM

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