The current controversy over the alleged DNA contamination of COVID-19 vaccines involves complex issues, and also shows the difficulties in arriving at truth in today’s polarized and politicized atmosphere, writes Jane Orient, M.D., in the winter issue of the Journal of American Physicians and Surgeons.
“The plasmid DNA contamination theory is not a sensational internet rumor, but a reality-based hypothesis prompted by standard laboratory research performed by professional researchers,” she writes.
The nidus of the theory is two preprints by Kevin McKernan and coauthors, and testimony before the South Carolina Senate by Phillip Buckhaults, Ph.D., the article states.
The source of the problem is in the industrial pharmaceutical production process. The Pfizer mRNA vaccine used in clinical trials employed a polymerase chain reaction (PCR) process to make the DNA that coded for the mRNA (Process 1). But scaling up production to make millions of doses used plasmids, small circular pieces of DNA in bacterial cells (Process 2). Then the product needs to be purified to remove the residual DNA, the article explains.
Recognizing the potential danger from DNA fragments, the Food and Drug Administration (FDA) sets limits on the allowable concentration, which these researchers claim were exceeded in the samples they tested.
No further trials were done on Process 2. Regulators and manufacturers assumed that it resulted in a “similar” product. But some researchers argue that some contaminants may induce autoimmune responses or myocarditis, or induce or accelerate cancers. Of special concern is the “promoter” sequence found in the genome of the carcinogenic simian virus 40 (SV 40), the article observes.
Critical appraisal identifies many limitations in the studies, which the authors freely acknowledge: e.g., the samples are few and lack a chain of custody, Dr. Orient points out.
Inclusion of DNA fragments in lipid nanoparticles may facilitate entry into the cell nucleus and integration into the genome, Dr. Buckhaults states. In his testimony, the article notes, he suggests sequencing the DNA in stem cells of patients experiencing adverse reactions to look for this “calling card.”
Further intense research is urgently needed, Dr. Orient concludes.
The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.
Read Full Article: https://jpands.org/vol28no4/orient.pdf