Kevin McKernon, one of our original members of Team Reality, and a very credentialed expert in all things DNA, gave a presentation to the FDA VRBPAC Advisory Committee.
Watch the video, but here are the main talking points:
Mr. Kevin McKernan, with 25 years of experience in genomics and several patents in PCR and sequencing, presented his findings related to mRNA vaccines.
In February, he discovered that the expression vectors for the mRNA vaccines remained in the vials, above the guidelines of the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). (Expression vectors are a type of plasmid or virus that is used in genetic engineering to introduce a specific gene into a target cell.)
The clinical trials used a process involving in vitro transcription off of synthetic DNA. For scale-up, they switched to a process involving E. coli to amplify plasmids, which are the leftover elements in the vials not present in the clinical trials.
McKernan found expression vectors in Pfizer and Moderna vaccines. Specifically, Pfizer's vaccine has an SV40 promoter, undisclosed in the expression vector map given to the FDA or EMA.
To verify his findings, McKernan designed quantitative PCR assays that targeted the spike sequence and the vector sequence, indicating the presence of DNA that should not be in the vials.
The tests showed that even with a 1 to 100 dilution, the results were above the EMA and FDA's limits.
McKernan pointed out a significant difference in the RNA to DNA ratios than what was expected, showing an 18 to 70-fold over the limit of the EMA's recommended ratio.
Anyone can readily assay these vaccines in any lab. If the vaccines are put directly into quantitative PCR, you can get Cts as low as 17.
The vials used for the study were sent to him anonymously in the mail. RNA integrity from these vials did not show a substantial difference from what has been published in the past.
Some people on Twitter have started to reproduce his findings, and the EMA documentation shows an 815-fold variance across 10 lots of double-stranded DNA contamination.
Double-stranded DNA can trigger interferon responses and pose risks of DNA integration into the genome.
McKernan encouraged everyone to reproduce this work using his publicly available primer sequences. He noted that his research did not measure any "bad lots" as per another paper's findings.
McKernan thanked the audience for their time and consideration after his presentation.
Video: Vial Contamination Uncovered. FDA Confronted