Posted on 08/25/2021 7:50:05 PM PDT by Missouri gal
On the Aug. 24 morning edition of “War Room: Pandemic,” vaccinologist Dr. Robert Malone called out the Food and Drug Administration for playing a “bureaucratic shell game” with their supposed early approval of the Pfizer Covid-19 vaccine.
In fact, Malone noted, the FDA issued two separate and distinct letters.
“There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and it will only be initiated at the time BioNTech product becomes available…
“The liability coverage, the blanket coverage that allows Pfizer to not be liable for any adverse event, only applies to the Pfizer product, which is still under emergency use authorization.”
(Excerpt) Read more at warroom.org ...
Too many words hurt unfrozen, unvaxed Caveman Lawyer’s head. Caveman Lawyer go back in cave for hundred years.
“Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19)...”
FINALLY! A vaccine that will actually PREVENT the disease, rather than just making it less deadly.
What the hell is that supposed to mean. Speak English please.
The FDA approval is a political answer to a medical problem.
Pfizer heavily influenced by CCP on their board, and CDC heavily influenced by Pfizer dollars and it looks like FDA is either on board for profit or politics or maybe CCP infiltrators.
“is it me or does this sound strange?“
It certainly is not you. When they inoculated the control group they invalidated the entire study. Shenanigans of the highest order.
It is available, worldwide. It’s a label. The exact same formulation as what Pfizer has been using in the U.S.
Malone is a doctor, not a lawyer. This process is regulatory, it has absolutely nothing to do with medicine. It doesn’t surprise me that he can’t figure out what happened.
It’s actually very simple.
The Pfizer-BioNTech drug is the same, regardless of what label is slapped on it. It has the exact same components, the exact same formulation, and it can be used interchangeably.
The BLA was approved for that formulation with the proprietary name “Comirnaty” for a two-dose regimen people 16 and older.
For third doses and for 12-15 year olds, they will use the Pfizer label.
The drug is the same, the usage in both cases is different.
Contrary to what Malone says, immunity is the same REGARDLESS. Full approval doesn’t suddenly make the manufacturer liable. There are layers of immunity, both under the PREP Act and under 300-aa22 of the U.S. Code.
Malone’s entire premise is garbage.
https://www.fda.gov/media/144414/download
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
FINALLY! A vaccine that will actually PREVENT the disease, rather than just making it less deadly.
They should license the time machine they used to get approval in 11 months vs 5-10 years. Why doesn’t the Pfizer CEO take his own vaccination? What is he afraid of? I think I know.
It means that sometimes it’s better to just retreat into one’s cave and wait out a pestilence than to talk a thing to death.
Here is the actual statement from Pfizer.
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Indication & Authorized Use
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
prevent COVID-19 in individuals 12 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
It looks like they split the name for the sake of approval.
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