Thursday, August 26, 2021

FDA says licensed vaccines are identical but distinct. Are EUA AND approved. FDA wants to have its cake and eat it too. Don't let them.

How has FDA attempted to explain the confusing and contradictory information it issued on Monday?  Look at FDA's word salad:

"Will the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?

The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved."

Sorry, FDA, you are lying in the prior sentence.  A vial of vaccine is either approved (licensed) or authorized under EUA.  It cannot be both, unless the licensed drug/vaccine is being used off-label.  In fact, you pointed out that the vaccine under EUA, compared to the fully approved, licensed vaccine, was "legally distinct."  And in the paragraph below you contradict yourself, saying providers can use the EUA vaccine as if it was approved. A licensed vaccine, being used for the purpose for which it was licensed, is not supposed to get an EUA liability waiver.  It's one more scam.--Nass

How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?

The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.  Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine."


Anonymous said...


Anonymous said...

If you have a large control group that doesn't take the vax and doesn't die then the gig is up. If everyone takes it and dies then you can just claim its the next bad thing that got them.

Anonymous said...

'Japan Finds A Substance That Reacts To Magnets In Moderna Vax, Suspends Use, Dumps 1.6 Million Doses'!
The country’s health ministry said “foreign materials” were found in at least 390 doses—or 39 vials—of the Moderna vaccine, coming from eight vaccination sites, according to The Asahi Shimbun.

A ministry official was reported by Nikkei Asia as saying, “It’s a substance that reacts to magnets … it could be metal.”

Anonymous said...

August 26, 2021

'The FDA did NOT grant full approval to the Pfizer shots'
By Carl Schwitzer

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.

There's just one problem.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.

Anonymous said...

In my mind the "science on the Pfizer vaccine" JUMPED OUT THE WINDOW when the participants in the control group were offered the vaccine after the first 30 or 60 days.
(Most took the vaccine, suggesting that the trial was not based on a randomized sample.)
No control group equals no science. (there is an article about this elimination of the control group somewhere on this blog, but I can't find it.)

Will the vaccinated suffer from antibody dependent enhancement (ADE)??
Will the vaccine be effective for other mutations??
What is the rate of injury /death in the control group? - we will never know.
Would someone please show me the science!

We had a great opportunity to make a risk benefit analysis by comparing the vaccinated to the unvaccinated over time. When the manufacturer was allowed to get rid of the control group they effectively got rid of the evidence.

Importantly, I think that this protocol changed DURING the course of the study. I am not an expert on clinical trials but I thought this type of thing had to be spelled out and approved by an IRB board BEFORE the study begins! Once the study commences the study cannot deviate from the original protocol - this alone should invalidate the licensure of the vaccine!

Am I conflating my facts?
Dr. Nass can you please comment on this.

Anonymous said...

Classic deflection without addressing root issues:

"For the purposes of administration, doses distributed under the EUA are interchangeable with licensed doses."

Perhaps not interchangeable legally?

Anonymous said...

Green Tea?
Covid-19 is caused by the virus called SARS-CoV-2 (“the Coronavirus”). SARS is caused by the virus called SARS-CoV or SARS-CoV-1. The two viruses are similar, and so researchers began their search for treatments of SARS-CoV-2 by looking at the research on SARS-CoV-1. One of the compounds found to be effective against SARS was zinc ions. But zinc requires an ionophore to carry the zinc ions past the lipid bilayer of the cell membrane into the cytoplasm of human cells. EGCG, a component of Green Tea Extract (GTE), is one such zinc ionophore.

The EGCG can latch on to the zinc ion and carry it into the cell cytoplasm, where the zinc inhibits a viral protein called replicase. Replicase (or RdRp) makes copies of viral RNA. Both SARS-CoV-1 and SARS-CoV-2 have a replicase protein. The replicase protein complex (made up of several proteins) is blocked by zinc ions, preventing the virus from making copies of its RNA. This stops the virus from multiplying.

KRolson said...

So, the claimed primary difference between the FDA-“approved” Pfizer-BioNTech product Comirnaty and the FDA-“authorized” Pfizer-BioNTech COVID-19 Vaccine. Has nothing to do with the formulation. So, it is the same vaccine only under one name it is “Approved” by the FDA and under the other name it is “Authorized” for use under the EUA.

In this arrangement between Pfizer and the FDA. The FDA allows Pfizer to enjoy the liability protection of the EUA by only marketing the vaccine under the “Authorized” vaccine name. While Pfizer can claim FDA Approval for its vaccine formulation under its un-marketed FDA “Approved” vaccine name.

It also allows the implementation of Vaccine Mandates due to their now being an FDA “Approved” vaccine. Even though the “Approved” vaccine name is un-marketed. Due to Pfizer only marketing its vaccine under the "Authorized" vaccine name.

Therefore, this is an attempt to enable Vaccine Mandates while only marketing vaccines under EUA protection from liabilities.

Meryl Nass, M.D. said...

For the confused person, the simplest way to get at this is to go to my BIG NEWS post, and print out the FDA's Fact Sheet to which I link.

It tells you in black and white that the vaccine is under EUA and that you have the right to refuse.

Make copies. Hand out to all your coworkers. Wake everyone up. Then you refuse, together, and the employer is not going to get into a legal battle with the whole group. That is how you win this battle.

Yes, we are still in a war, but in a war you win one battle at a time.