This seems to be were MB is getting his quote from (indirectly and filtered through conspiracy theory commentary of course):
https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm
Currently, mRNA is considered a gene therapy product by the FDA
This does not give specifics about the FDA ruling in question.
Later in the same document is a clear implication that Moderna's mRNA vaccines are NOT gene therapy:
safety or efficacy concerns regarding our investigational medicines may result from any safety or efficacy concerns arising from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived as similar to ours;
@athousandyoung saidThat is correct......and it is still gene therapy according to the FDA and Moderna's SEC filings. Moderna told the SEC it is gene therapy according to the FDA and could negatively impact their sales if it is known.
The J&J vaccine adds a gene to create viral proteins from what I understand. This would not alter the genes which are already there.
The mRNA vaccines do not interact with or modify your genes in any way.
Conclusion: The assertion gene therapy must alter DNA is false.
@athousandyoung saidThe FDA's ruling was never in question.
This seems to be were MB is getting his quote from (indirectly and filtered through conspiracy theory commentary of course):https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm
Currently, mRNA is considered a gene therapy product by the FDA
This does not give specifics about the FDA ruling in question.
@metal-brain saidNo the conclusion is that the FDA is using scientifically incorrect definitions.
That is correct......and it is still gene therapy according to the FDA and Moderna's SEC filings. Moderna told the SEC it is gene therapy according to the FDA and could negatively impact their sales if it is known.
Conclusion: The assertion gene therapy must alter DNA is false.
@metal-brain saidThen why don't you give a direct link to that ruling?
The FDA's ruling was never in question.
@athousandyoung saidLOL! Take that up with the FDA.
No the conclusion is that the FDA is using scientifically incorrect definitions.
Wasn't it the FDA that changed the definition of vaccine to include gene therapy so they would have immunity from liability?
@athousandyoung saidI don't know if such a link exists. Does the FDA make all of that information accessible to the public? Are you accusing Moderna of lying to the SEC against their own interests now?
Then why don't you give a direct link to that ruling?
@metal-brain saidNo need. It is sufficient to clarify which definition is being used in which context - are we discussing this medically, with medical definitions, or legally, with the FDA definition?
LOL! Take that up with the FDA.
Wasn't it the FDA that changed the definition of vaccine to include gene therapy so they would have immunity from liability?
This was edited in above but may have been missed:
Later in the same document is a clear implication that Moderna's mRNA vaccines are NOT gene therapy:
safety or efficacy concerns regarding our investigational medicines may result from any safety or efficacy concerns arising from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived as similar to ours;
So using this document as a source for the definition of "gene therapy" is not possible as the document is internally inconsistent about this.
@athousandyoung saidYou clearly did not read this article in it's entirety. I suggest you do that.
No need. It is sufficient to clarify which definition is being used in which context - are we discussing this medically, with medical definitions, or legally, with the FDA definition?
https://sambentleygraphics.weebly.com/blog/covid-19-vaccines-are-gene-therapy
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@athousandyoung saidWhat document is internally inconsistent about what?
This was edited in above but may have been missed:
Later in the same document is a clear implication that Moderna's mRNA vaccines are NOT gene therapy:
[quote]safety or efficacy concerns regarding our investigational medicines may result from any safety or efficacy concerns arising from nonclinical or clinical testing of other therapies targeting a similar diseas ...[text shortened]... definition of "gene therapy" is not possible as the document is internally inconsistent about this.
You are becoming increasingly vague.
Moderna stated clearly that the FDA considers mRNA gene therapy. Funny how you are entertaining the possibility that the FDA is contradicting itself but not Moderna.
@metal-brain saidYou clearly did not read this document in its entirety. I suggest you do that.
What document is internally inconsistent about what?
You are becoming increasingly vague.
https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm
@athousandyoung saidI read that document months ago, possibly years. I posted it on this forum a long time ago.
You clearly did not read this document in its entirety. I suggest you do that.
https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm
I already read that. Now you read the article I provided to you. It answers the questions you have about "definitions". That is how I know you ignored it.
@metal-brain saidRead it again because you aren't recognizing direct quotes from it and seem unable to reference it but instead prefer to reference commentary that takes one line out of context and then spins it into conspiracy nonsense.
I read that document months ago, possibly years. I posted it on this forum a long time ago.
I already read that. Now you read the article I provided to you. It answers the questions you have about "definitions". That is how I know you ignored it.
I'm not interested in that blog entry in which the author is not identified.
@athousandyoung saidPost the relevant excerpts like I do.
Read it again because you aren't recognizing direct quotes from it and seem unable to reference it but instead prefer to reference commentary that takes one line out of context and then spins it into conspiracy nonsense.
I'm not interested in that blog entry in which the author is not identified.