Replies

“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

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.

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