Abstract
Background: BNT162b2 RNA-based COVID-19 injections are specified to transfect human cells to efficiently produce spike proteins for an immune response.
Methods: We analyzed four German BNT162b2 lots applying HEK293 cell culture, immunohistochemistry, ELISA, PCR, and mass spectrometry.
Results: We demonstrate successful transfection of nucleoside-modified mRNA (modRNA) biologicals into HEK293 cells and show robust levels of spike proteins over several days of cell culture. Secretion into cell supernatants occurred predominantly via extracellular vesicles enriched for exosome markers. We further analyzed RNA and DNA contents of these vials and identified large amounts of DNA after RNase A digestion in all lots with concentrations ranging from 32.7 ng to 43.4 ng per clinical dose. This far exceeds the maximal acceptable concentration of 10 ng per clinical dose that has been set by international regulatory authorities. Gene analyses with selected PCR primer pairs proved that residual DNA represents not only fragments of the DNA matrices coding for the spike gene, but of all genes from the plasmid including the SV40 promoter/enhancer and the antibiotic resistance gene.
Conclusion: Our results raise grave concerns regarding the safety of the BNT162b2 vaccine and call for an immediate halt of all RNA biologicals unless these concerns can be dispelled.
