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
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