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Sputnik V: fraudulent clinical trial data

forbetterscience.com

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Re: Sputnik V: fraudulent clinical trial data

#21

Post by m0zg »

rangoon626 wrote: post #19
m0zg wrote: post #10

Pfizer vaxed their control group at the beginning of 2021. So their long term clinical data is not just "fraudulent", it's non-existent [1]. And yet, it was FDA approved yesterday, without even knowing how many shots there are in the regimen, _and_ without dropping legal immunity for Pfizer for severe adverse effects. Some companies are more equal than others. Approved by the same person, by the way, who was responsi…

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download

So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...

Re: Sputnik V: fraudulent clinical trial data

#22

Post by brokensegue »

rangoon626 wrote: post #19
m0zg wrote: post #10

Pfizer vaxed their control group at the beginning of 2021. So their long term clinical data is not just "fraudulent", it's non-existent [1]. And yet, it was FDA approved yesterday, without even knowing how many shots there are in the regimen, _and_ without dropping legal immunity for Pfizer for severe adverse effects. Some companies are more equal than others. Approved by the same person, by the way, who was responsi…

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download

It says the biologics license application is approved. It also talks about the extension of the EUA but the drug was approved.

Re: Sputnik V: fraudulent clinical trial data

#23

Post by rangoon626 »

m0zg wrote: post #21
rangoon626 wrote: post #19

Earlier quoted context omitted.

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download

So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...

You are countering my primary source with a secondary source.

Did you read the letter?

Please at least skim the letter and then form your own conclusion about CNN.

Re: Sputnik V: fraudulent clinical trial data

#24

Post by erentz »

harringtonjones wrote: post #12
hamburgerwah wrote: post #7

I think that what is sort of a sideline in this article is really a more important story. The Lancet and NEJM have completely debased themselves and destroyed centuries of institutional credibility in their handling of covid related research. I don't know where it goes from here but they have both burned themselves to the ground.

I thought that happened to the Lancet after the original vaccines -> autism paper...

And the PACE trial

Re: Sputnik V: fraudulent clinical trial data

#25

Post by goostavos »

rangoon626 wrote: post #19
m0zg wrote: post #10

Pfizer vaxed their control group at the beginning of 2021. So their long term clinical data is not just "fraudulent", it's non-existent [1]. And yet, it was FDA approved yesterday, without even knowing how many shots there are in the regimen, _and_ without dropping legal immunity for Pfizer for severe adverse effects. Some companies are more equal than others. Approved by the same person, by the way, who was responsi…

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download

I don't think there's a conspiracy here. fda.gov has a formal announcement on their home page.

https://www.fda.gov/news-events/press-announcements/fda-appr...

>Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.

The 12-15 group is still under EUA.

Re: Sputnik V: fraudulent clinical trial data

#26

Post by sveiss »

rangoon626 wrote: post #19
m0zg wrote: post #10

Pfizer vaxed their control group at the beginning of 2021. So their long term clinical data is not just "fraudulent", it's non-existent [1]. And yet, it was FDA approved yesterday, without even knowing how many shots there are in the regimen, _and_ without dropping legal immunity for Pfizer for severe adverse effects. Some companies are more equal than others. Approved by the same person, by the way, who was responsi…

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download

Quoting the FDA letter you linked:

> On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave formal approval is because the FDA did in fact do that.

The letter goes on to say:

> 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.

So as well as granting formal approval, they _also_ extended the EUA.

Why did they do both?:

The extension of the EUA covers the existing vials of vaccine in the field and the supply chain which don’t have the approved labelling. Drug and biologic products are approved for sale under conditions that include specific labelling (the brand, in this case “Comirnaty” and the prescriber/patient instructions) and for specific indications.

The stock in the supply chain doesn’t meet those requirements, but it would be wasteful to recall it. Additionally, the EUA authorises more indications than the full BLA: kids 12-16, for one. The old stock, and now the new Cominarty-labelled stock, are authorised for these populations under the extended EUA.

Re: Sputnik V: fraudulent clinical trial data

#27

Post by chomp »

m0zg wrote: post #18
sterlind wrote: post #14

Earlier quoted context omitted.

It's not really ethical to keep the control group unvaccinated once Phase III was over and the EUA was approved. Ethics aside, the control group would probably leave the trial to get vaccinated anyway.

How do you establish long term safety of the vaccine if you don't have a control group of randomly chosen, unvaccinated people? And if you don't, then how did it get approved?

How long are you talking? I mean, nothing stops these people from going off and getting the vaccine themselves; what are you going to do, send mailers to them to never get a covid vaccine for the rest of their lives so that we can study them?

Re: Sputnik V: fraudulent clinical trial data

#28

Post by Stratoscope »

sveiss wrote: post #26
rangoon626 wrote: post #19

Earlier quoted context omitted.

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download

Quoting the FDA letter you linked: > On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave f…

Thank you for the informative and insightful comment.

Perhaps surprisingly, I also thank GP (rangoon626). Even if their claim was wrong, it nudged you to write this clarification, in accordance with Cunningham's Law.

https://en.wikipedia.org/wiki/Ward_Cunningham

Re: Sputnik V: fraudulent clinical trial data

#29

Post by [deleted] »

rangoon626 wrote: post #23
m0zg wrote: post #21

Earlier quoted context omitted.

So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...

You are countering my primary source with a secondary source. Did you read the letter? Please at least skim the letter and then form your own conclusion about CNN.

[deleted]

Re: Sputnik V: fraudulent clinical trial data

#30

Post by perl4ever »

rangoon626 wrote: post #23
m0zg wrote: post #21

Earlier quoted context omitted.

So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...

You are countering my primary source with a secondary source. Did you read the letter? Please at least skim the letter and then form your own conclusion about CNN.

I looked at the letter, and I believe you have misinterpreted it.

They approved the drug fully for ages 16 and over. That appears to be separate and in addition to a renewed EUA.

There is a renewed EUA in order to allow the shot to be given to under 16s, and to allow the shot to be given to anyone without a prescription.

There might be more to it, I didn't go over every line, but that's the basic outline of where I think you misunderstood.

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