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 ...
How can you approve something that has not been produced yet?
“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…“
Wrong. The actual BLA approval letter is here:
https://www.fda.gov/media/151710/download
It’s the exact same product labeled under the proprietary name COMIRNATY. It can now be marked and packed in 2.0 mL glass vials, in packages of 25 and 195 vials.
Pfizer-BioNTech have already been distributing the drug under the COMIRNATY label in Europe since January and since July in Australia.
Claims that it doesn’t exist is a bold faced lie.
Here is what it looks like: https://thumbor.forbes.com/thumbor/711x490/https://specials-images.forbesimg.com/imageserve/61241aea6a73959e462e80fa/Comirnaty-Pfizer-BioNTech-Covid-19-vaccine/960x0.jpg?fit=scale
“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.”
Wrong. Vaccine makers are immune from liability regardless. A EUA is irrelevant.
https://www.law.cornell.edu/uscode/text/42/300aa-22
It’s been produced AND distributed:
In addition to 300aa-22 immunity there is also PREP Act immunity which covers:
“any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured:
to diagnose, mitigate, prevent, treat, or cure COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or
to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause;
a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above;
a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above; or
any device used in the administration of any such product, and all components and constituent materials of any such product.”
Again, full approval or EUA is irrelevant.
Do you have another link? An image of two bottles doesn't imply the vaccine has been produced and distributed.
They’ve been administering it in Europe under the Comirnaty Brand name since JANUARY.
It’s been approved in Australia since July under the same name:
https://www.fda.gov/media/144414/download
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
So what actually happened? Who got what authorization? Is it correct to say that Pfizer got the EUA extended, and BioTech got full approval?
Pfizer and BioNTech developed the vaccine together; it’s not two different products.
The use is still EUA for 12 to 15 year olds; it’s fully approved for 16 and above.
if only the following would lead to so-called “essential” media reporting more honestly about the jabs! doubt it will happen, though:
26 Aug: news.com.au: Channel 7 journalist hospitalised with pericarditis after Pfizer vaccine
Channel 7 reporter Denham Hitchcock has spoken from hospital after being diagnosed with pericarditis, a rare side effect of the Pfizer vaccine.
by Natalie Brown
In a post to Instagram, the Channel 7 journalist wrote that he’d “battled over whether” to share his experience or not, “but decided after 27 years of being a journalist who’s primary goal is to discover the truth – it would be hypocritical not to”.
“I’m NOT anti-vax. But I’m really not pro vax either. I’m pro choice – and pro information to make that choice. Above all I’m PRO opening the bloody country up and to do that I don’t see any way around getting the majority of Australia vaccinated. So I got the Pfizer shot,” Hitchcock said.
“The first week was like any vaccine. Feeling off. But nearing the end of the second week my heart started to race, I was getting pins and needles in the arms, extreme fatigue and a very strange sensation of dizziness. I took Nurofen, and I kept working.
“By the end of the third week I was getting steadily worse – sharp chest pain – cold shivers and chills – and the dizziness was intense. 25 days after the shot and probably a little late to hospital – but here I am – diagnosed with pericarditis – or inflammation of the heart due to the Pfizer vaccine.”...
“My present thought would be – in the current vaccine frenzy, no one is talking about this but it’s clearly happening – and if you want the vaccine and have any heart history it would be worth talking to your GP about your vaccine choice, especially as AZ is readily available and does not have this side effect,” Hitchcock advised...
Hitchcock’s diagnosis comes after Georgia Clark, a reporter with (Murdoch’s) The Daily Telegraph, also revealed that she was being treated for pericarditis – but urged Aussies to continue coming forward to get vaccinated.
“If this is what the vaccine has done to me, who knows what would happen if I actually caught Covid, I could die,” the 27-year-old told The Daily Telegraph...
https://www.news.com.au/lifestyle/health/health-problems/channel-7-journalist-hospitalised-with-pericarditis-after-pfizer-vaccine/news-story/43e3d637eeea6827962aa973db8cda7e
Thanks. I’ll check that out.
Fastest approval of any vaccine in the history of mankind….by orders of magnitude.
How on the earth do you give approval for something with absolutely zero long term data? Coupled with short term data showing no ability to stop infection nor transmission.
And I have not even brought up our adverse events database…..
This approval is a complete and utter farce.
I think it is a stretch to call what Malone said a “bald-faced lie.” You may disagree with his interpretation, but seriously, you are saying Malone is telling “a blatantly obvious and/or impudent untruth, one in which the liar does not attempt to disguise their mendacity?”
I believe the footnote below indicates COMIRNATY is not available in US...It does not exist in US...That is what Malone said and meant...And this is about the US approval.
Note this: Page 5 https://www.fda.gov/media/150386/download
There is no adequate, approved, and available9 alternative to the emergency use of
Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.
10
~~~~~~~~~~~~~~~~~~~~~~~~
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.
Note this: Page 12 & 13 of PFE letter
https://www.fda.gov/media/150386/download
Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of PfizerBioNTech COVID-19 vaccine that was manufactured and labeled in accordance with
this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use
to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have
undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19
Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.
IV. Duration of Authorization
Page 13 – Pfizer Inc.
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products during the COVID-19
pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section
564(g) of the Act.
**Reissuance of EUA...
Been a long day — ended it helping family member prepare 2 waiver exemptions being mandated to take the “PFE ‘APPROVED VACCINE’” or lose their jobs. So I have no more time to research what all you have posted. That said, but I found these factoids interesting. I am not sure of your background, but I think given the flak he has gotten, Malone has been over the target on many things.
BTW, I don’t think he is a “QTard,” nor am I just because I find merit in his interpretation. After today, don’t need or appreciate that label.
Malone’s credentials:
https://www.rwmalonemd.com/mrna-vaccine-inventor
I am not really sure how “rare” this side effect is... The same exact thing happened to my brother who had been an airline captain for a major airline for decades. He was having some weird sensations, but he kept flying until his FAA 1st class flight physical that he is required to have every 6 months. He was diagnosed with an enlarged and inflamed heart... Grounded of course... a bunch more tests and a month or so later it was decided that he could fly again. But as a condition he has to keep having checks of his heart. He is in his 50s and had no history of heart problems before taking the Pfizer.
Why would anyone believe any government agency after all that has happened?
I don’t see that he claimed it doesn’t exist. He said, until it “becomes available.” It’s apparently not yet available in the U.S., which is where the FDA has authority. You misrepresented what he said and then called him a liar.
There are so many FIRST HAND DIRECT reports by Freepers like yours of adverse effects from the FRANKENSTEIN jabs. Either a lot of those reports are lies (Uh... NO!!) or the official stats for adverse effects are TOTALLY FRAUDULENT.
If the vax shills state that the odds of a seriuos adverse effect is something like in one million then only .1 percent of all freepers should be posting actual first hand reports of same.
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