Health Canada Unfazed by Scientists’ Discovery of Plasmid DNA Contamination in COVID Vaccines

After two scientists raised concerns about the amount of plasmid DNA in the COVID-19 mRNA shots, Health Canada stated that it did not express concern based on the testing data provided by the manufacturers. The presence of residual plasmid DNA is a process-related impurity, and it is supposed to be removed to a level below a threshold set by health regulatory agencies before the final vaccine product is distributed.

Microbiologist Kevin McKernan discovered that the quantity of DNA in the vaccines could potentially be 18 to 70 times higher than the limits set by one regulatory agency. Health Canada did not mention conducting its own testing but stated that it reviews the testing data provided by the manufacturers for every vaccine lot. The agency emphasized the importance of using authorized validated assays performed by the manufacturers to assess the results and ensure the quality of commercial vaccine lots.

Kevin McKernan, a chief scientific officer and founder of a biotech company, conducted research that showed the presence of double-stranded DNA plasmids in expired Pfizer and Moderna COVID-19 vaccine vials. The quantities of DNA contamination exceeded regulatory requirements, raising concerns about potential genome alteration. Health Canada stated that the presence of residual plasmid DNA does not change the safety assessment of the vaccines.

Another scientist, Dr. Phillip J. Buckhaults, also raised similar concerns about the presence of plasmid DNA in the vaccines. He found up to 2.5 billion molecules of plasmid and about 100-200 billion pieces of plasmid DNA per Pfizer dose, which exceeded the limits set by the FDA and WHO. Dr. Buckhaults cautioned that the measurements were not very precise but emphasized the importance of checking vaccinated individuals for any evidence of genome modification.

Health Canada did not indicate if it would verify the findings of McKernan and Buckhaults or explore the potential consequences to Canadians’ health. The agency stated that the risk/benefit profile of the Pfizer-BioNTech vaccine supports its use based on its evaluation of the available data. There were concerns raised about the manufacturing processes used in clinical trials versus mass production, but Health Canada maintains that the efficacy and safety demonstrated in clinical batches using one process are applicable to commercial batches produced using a different process.



Source link