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August 31, 2021

Coronavirus, week 73A: Yes, Pfizer has full approval

The man who claims to have invented mRNA vaccination technology, Robert Malone, is also a COVID antivaxxer, which he denies. TLDR, or preview? He's overstating his vaccine work claims (which is nonetheless not insubstantial), he IS a COVID antivaxxer, and despite his graduate work, he's idiot enough to have gotten a vaccine AFTER getting COVID and thinking it would reverse the already started effects of infection, which in his case seems to include long-haul COVID. Sadly, wingnut media is giving him the recognition he craves.

Malone is also apparently the nut who started mongering the claim that Pfizer's vaccine, now with the name of Comirnaty, has not "really" gotten full approval and is still on an EUA, per Orac. (Somebody emailed my newspaper about this.) 

Orac says that FDA's full approval language got exploited by the wingnuts. Here's the relevant graf:

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID- 19 Vaccine, mRNA).

That's followed by his explanation:

The language about Comirnaty is, as is often the case, confusing legalese and jargon. First of all, what this means is that, while Comirnaty is now fully FDA-approved for use in people age 16 and older to prevent COVID-19, its use in those aged 12-15 will fall under an updated EUA rather than full FDA approval, just as the Pfizer/BioNTech vaccine’s use has since the EUA was issued for this indication in May. The reason is simple. Approval of a biologics license application (BLA) requires more followup data than an EUA, and insufficient time has passed since the clinical trial upon which the FDA based its May EUA that authorized use of the Pfizer vaccine in children aged 12-15 was concluded.

So, there you go. 

Greg Hunter has amplified this nonsense started by Malone, and it's so bad that even nutters at Natural News are jumping ship on this one. And, the FDA already has his number on the claim this is different than the Pfizer BioNTech. Here.

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.

Boom!

And, this keeps Orac, with all his tribalism around the WIV lab leak theory, from being deblogrolled.

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