TUCSON, Ariz., Dec. 09, 2024 (GLOBE NEWSWIRE) -- The regulatory framework has broken down for Pfizer/BioNTech’s COVID-19 vaccines, write Philip Oldfield and coauthors in the winter issue of the Journal of American Physicians and Surgeons.
The COVID-19 products, designated as modRNA vaccines because they use a modified form of messenger RNA (mRNA), are not classified as gene therapy products, unlike comparable products against a non-infectious disease such as cancer, the authors explain. The difference is that manufacturers of a gene therapy product are required to determine the structure, concentration, and biodistribution of the protein that has been coded for, and this is not done for vaccines.
ModRNA vaccines are basically different from traditional vaccines, the authors state. Instead of containing a fixed amount of the antigen to which an immune response is to be stimulated, they are like a “prodrug,” which causes the production of the “active drug,” the spike protein antigen. Injected individuals may produce variable amounts of spike protein for variable durations of time based on their genetics, age, hormonal and nutritional state, athletic condition, and batch of vaccine they receive. Studies to investigate these factors were never performed in the preclinical and clinical phases of development.
For example, World Health Organization (WHO) regulatory guidelines for DNA contamination are not applicable to DNA transfected into cells inside lipid nanoparticles (LNPs), nor do guidelines account for multiple dosing, authors point out. The numerous flaws and omissions include: the use of only one animal species (an inappropriate one) to study spike protein toxicity, no assessment of potential autoimmune effects, and no genotoxicity or carcinogenicity studies.
Regulatory agencies in the U.S., Europe, and Canada ignored or downgraded issues of concern, the authors state. “For any other medicinal product, the regulatory submission would have been considered incomplete and most probably rejected. Therefore, a moratorium on the use of Pfizer/BioNTech COVID-19 vaccines and boosters should be enacted at minimum…. Based upon Pfizer/BioNTech’s data, safety of their COVID-19 modRNA vaccine has not been proven.”
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.
Contact: Jane M. Orient, M.D., (520) 323-3110, janeorientmd@gmail.com
