FDA Zolgensma Cancer Risk Announcement and COVID Vaccine Comparison

This is breaking news. The FDA just confirmed gene therapy DNA integrated into human genomes causing cancer.

In a stunning safety announcement, the FDA has actually confirmed cases of insertional mutagenesis involving Zolgensma, a viral vector gene therapy that uses the same broad category of DNA delivery technology as the Johnson & Johnson and AstraZeneca COVID shots.

So in some patients who developed tumors, molecular testing revealed that DNA from the gene therapy had integrated directly into their chromosomes, affecting a cancer-associated gene called GLI1.

Now, here's where things get interesting.

Both Zolgensma gene therapy and the viral vector COVID shots, which you'll see the mechanism here, uh, they both deliver genetic material into the nuclei of human cells where our chromosomes are located.

Zolgensma uses an adeno-associated virus known as AAV9 to deliver single-stranded DNA, uh, but Johnson & Johnson and AstraZeneca use modified adenoviruses to deliver double-stranded DNA encoding for the coronavirus spike protein.

And so they're different viral vectors, but they share the same fundamental feature, DNA delivery into the nucleus.

And so it looks like it's not just mRNA shots that can integrate into chromosomes and lead to tumor growth.