Before a medication may be sold for public use, it must undergo a rigorous approval process by regulatory agencies. In Canada, this is the role of Health Canada. In Europe, The European Medicines Agency (EMA) oversees this process. An independent analysis of the material provided to the EMA has revealed many deficiencies and omissions in the manufacturing and quality of the BNT162b BioNTech/Pfizer vaccine. The conclusion is that there is not enough evidence that this vaccine product meets the quality required of a pharmaceutical product. This raises questions about the safety of these quasi-vaccines. The recommendation is that the use of these products must be halted until the concerns of the review are addressed.