DNA-kontaminering i mRNA vaccin

Education

• Ph.D. Biochemistry and Molecular Biology, University of Georgia, 1996
• M.S. Biochemistry and Molecular Biology, University of California, San Diego, 1991
• B.S. Chemistry, University of South Florida, 1988

Background

• Phillip Buckhaults, Ph.D., is an experienced molecular biologist and cancer geneticists who has extensive experience with next-gen sequencing applications for global gene expression analysis and gene mutation detection.

Earlier this year, genomics expert Kevin McKernan first discovered DNA contamination in vials of Pfizer and Moderna’s bivalent booster shots. He published his findings in a pre-print, but the research received little attention from the mainstream media.

Observing from afar was Phillip Buckhaults, a cancer genomics expert, and professor at the University of South Carolina. Initially, he dismissed McKernan’s findings as “conspiracy” and decided to debunk the work by carrying out his own testing on the mRNA vials.

But what Buckhaults discovered shocked him --> McKernan was right! Buckhaults found billions of tiny DNA fragments in Pfizer’s mRNA vaccine, and recently testified about it before a South Carolina Senate hearing

Several methods were deployed to assess the nucleic acid composition of four expired vials of the Moderna and Pfizer bivalent mRNA vaccines. Two vials from each vendor were evaluated with Illumina sequencing, qPCR, RT-qPCR, Qubit™ 3 fluorometry and Agilent Tape Station™ electrophoresis. Multiple assays support DNA contamination that exceeds the European Medicines Agency (EMA) 330ng/mg requirement and the FDAs 10ng/dose requirements.

DEMASI: I read somewhere the FDA allows about 10ng of residual DNA to be left in the vaccine and that’s thought to be safe….?

BUCKHAULTS: I am not a regulatory expert but it appears this is a magic line the FDA arrived at before lipid nanoparticles existed. It was back when they were just injecting proteins and or attenuated viruses that they made in CHO cells and a little bit of DNA comes along for the ride, but it's naked DNA. Right? And they've done studies where they inject gobs of naked DNA into mice and never see any problems. But this isn’t naked DNA. This is different and that's what gives me pause that may be the regulatory limit is just not relevant to mRNA vaccines that have lipid-nanoparticles or LNPs, transporting the genetic material to the inside of cells.

The LNPs facilitate getting the DNA inside the cell - just inside the cell membrane. But once it's in the cytoplasm, bits of DNA go to the nucleus just by random chance. And that would happen no matter what the delivery mechanism was. Once the LNPs fuse with the membrane of cells and dump their cargo into the cytoplasm, they’ve done their job.