Fundamental Flaws in Pfizer’s COVID-19 Biologics License Application Submission, and the Implications to the Safety and Effectiveness of These Novel Gene Therapy Vaccines

Philip R. Oldfield and Maria L. Gutschi

The mRNA COVID-19 vaccines are using gene therapy technology in which the active product, the encoded spike protein, is not actually part of the formulation.

Health Canada has used an inappropriate guidance document for the regulatory review, contrary to Good Scientific Practice, effectively compromising the safety of Canadians.

Chemistry, manufacturing and control processes were substandard resulting a product with varying amounts of intact mRNA and wide margins for safety and purity of the final product were accepted that may affect safety and efficacy.

The basic pharmacology of the mRNA and the resulting spike remains unknown such as the fidelity of the translation of the mRNA, quantity of spike protein produced and the metabolism of the cationic and pegylated lipids.

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