“We have to make these viruses [we use in vaccines] in cell lines, because they’re too large to make in a test tube. So we make them in animal cell lines. We make them in human fetal cell lines. And people are developing methods to make these in plant cells now. And in that process, when you go to harvest the virus, you carry components of the producing cell line through to your final product. You cannot eliminate those.
And, for instance, in the chickenpox vaccine, 2 micrograms of double stranded DNA is present in the final product. That is from Merck’s measuring of the residual DNA levels, not from our measuring, and those numbers are contained in their summary basis for approval. Recommendations were originally that no more than 100 picograms of residual DNA be present in each vaccine. And those recommendations had been relaxed twice, now it’s at 10 nanograms, because the manufacturers could not meet those.
So here we have chickenpox, which is 2 micrograms… that’s 200-fold higher even than those relaxed recommendations. So because the FDA knows that the presence of this DNA poses a danger for genomic insertion, and they were worried about cancer… so what they thought is a cancer causing gene would come all the way through the manufacturing process and be inserted and cause cancer, they recommended that what the manufacturers do is chop up the residual DNA in the vaccines so that it’s about 250 nucleotides long… our DNA is made up of nucleotides… because the smallest known gene is 800 nucleotides.
And so the reasoning probably was, well if we chop it up into 250 nucleotides, we don’t have a whole gene, so we don’t need to worry about a cancer gene being inserted in the cancer protein being made. When they made those recommendations, we didn’t have the molecular biology information that we have now. But we know, and we know this primarily from scientists trying to do gene therapy, that those large fragments don’t insert into the genome, and it turns out that fragments, about 500 nucleotides and below, more readily insert into the recipient’s genome. And there’s a large body of scientific literature published on this.
So in trying to prevent the danger of a cancer gene, the recommendations have actually inadvertently created probably the most dangerous scenario. Now, the levels in Merck’s vaccine are so high that they did do additional safety studies, and those are contained in their summary basis for approval. However, they did not do the correct safety studies, because they looked at genomic insertion of this human DNA in mice, and genomic insertion is species specific. They needed to look at this insertion in human cell lines. So the appropriate studies have never been done.”
— Theresa Deisher, PhD, molecular and cellular physiology at Stanford University