mRNA Therapies Classified as Gene Therapy

@no1marauder said
I'm perfectly aware of that but you kept claiming that was the FDA saying it when it is, at best, a second hand claim made in a non-scientific document sent to stockholders. As such, it carries no weight.

And the only mRNA treatments (not vaccines) it mentions are immunotherapy.

Now you are. It was not the FDA. You were very confused and it is obvious.

Are you claiming that BioNTech statement to the SEC is a lie?
Now you really must be desperate. They have no incentive to say that unless it is true. It carries a lot of weight.

Why would they tell stockholders that if it is untrue? There is no motive for it. You are being ridiculous.

And this whole subject, where you try to use the FDA to validate your absurd claim that these aren't vaccines but "gene therapy" is utterly ludicrous since the FDA has specifically described them as "vaccines" repeatedly and consistently:

"Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention[not "treatment" - no1] of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.

The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of an EUA is not an FDA approval (licensure) of a vaccine. "

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

So what's the FDA think, MB? Or as you said on page 7 of this thread:

MB: Is the FDA a reliable source of information or not?

@metal-brain said
Now you are. It was not the FDA. You were very confused and it is obvious.

Are you claiming that BioNTech statement to the SEC is a lie?
Now you really must be desperate. They have no incentive to say that unless it is true. It carries a lot of weight.

Why would they tell stockholders that if it is untrue? There is no motive for it. You are being ridiculous.

I realize you don't know what a lie is since you accuse anyone who disagrees with you of "lying" but someone can make an inaccurate statement (or a statement not bearing on a product not even invented yet) without "having a deliberate intent to deceive". https://www.dictionary.com/browse/lie#:~:text=noun,or%20false%20statement%3B%20a%20falsehood.

@no1marauder said
And this whole subject, where you try to use the FDA to validate your absurd claim that these aren't vaccines but "gene therapy" is utterly ludicrous since the FDA has specifically described them as "vaccines" repeatedly and consistently:

"Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 [b]Vac ...[text shortened]... update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

So what's the FDA think, MB?

mRNA treatments and mRNA vaccines are only different because of prevention rather than treatment. The technology is the same.

The FDA classifies mRNA treatment as gene therapy. Using it for prevention doesn't change anything about it. It is the same process with a different protein, that is all.

Why do you support using mRNA for people that do not have anything wrong with them? Sinopharm doesn't alter cells people's bodies. Sinopharm is a real vaccine, not gene therapy.

If splitting hairs over the word treatment is all you have you have already lost. The mRNA treatments and mRNA vaccines are the same process. The only difference is the protein your cells are altered to produce.

@no1marauder said
I realize you don't know what a lie is since you accuse anyone who disagrees with you of "lying" but someone can make an inaccurate statement (or a statement not bearing on a product not even invented yet) without "having a deliberate intent to deceive". https://www.dictionary.com/browse/lie#:~:text=noun,or%20false%20statement%3B%20a%20falsehood.

You did have deliberate intent to deceive. You falsely claimed my source was not the FDA when I provided the FDA as my source.

The only way it could not be deliberate is if you neglected to read my post. I clearly posted an FDA link.

@metal-brain said
You did have deliberate intent to deceive. You falsely claimed my source was not the FDA when I provided the FDA as my source.

The only way it could not be deliberate is if you neglected to read my post. I clearly posted an FDA link.

You are wrong. Get over it.

BioNTech
From page 16:

"Currently, mRNA is considered a gene therapy product by the FDA."

https://www.sec.gov/Archives/edgar/data/1776985/000156459020014536/bntx-20f_20191231.htm

@Metal-Brain
The EXACT same thing is said about YOU. Why do you bother posting here? You get your jollies off trying to bend nature to your trolling?

@sonhouse said
@Metal-Brain
The EXACT same thing is said about YOU. Why do you bother posting here? You get your jollies off trying to bend nature to your trolling?

You are trolling. That is evident when you offer nothing but vague naysaying. That is what you are doing. You are the troll.