What Speicher et al are observing and reporting in this scientific manuscript linked below clearly demonstrates a profound failure of FDA and global regulatory authorities to do their most important job- to insure the purity and lack of adulteration of the pharmaceuticals which they authorize for marketing and use by physicians and allied health professionals.
At a minimum, it once again demonstrates the rampant willful blindness which seems to have pervaded the FDA/CBER vaccines branch under the “true believer” guidance of Dr. Peter Marks, who is neither a vaccine expert, nor an immunologist, nor a molecular biologist, nor someone who has any understanding of non-viral lipid nanoparticle-based polynucleotide delivery but rather is a clinical hematologist/oncologist that is the initial originator and continued proponent of the “operation warp speed” approach to vaccine (and now cancer drug) development. Which is to say bypassing almost all of the normal procedures and lessons learned from decades of development, manufacturing, approval for marketing and post-marketing surveillance of biological and drug products.
At worse, with this new information there is the appearance of a “smoking gun” demonstrating corrupt collusion between the US and other western administrative states’ pharmaceutical regulatory authorities and the pharmaceutical industry.
Based on my personal assessment of these data, this contamination appears to meet the formal criteria for pharmaceutical “adulteration”, which is strictly prohibited by US federal law. The prevention of drug, device and food “adulteration” is one of the central missions of the FDA – basically, a central reason that the FDA was created in the first place.
