Karen Vecchio on Questions on the Order Paper

With regard to the safety of novel therapeutic products approved by Health Canada (HC) through Agile Licensing: (a) does HC determine the specifications required to be completed by the manufacturer to determine a therapeutic product’s safety for use by Canadians based primarily on its (i) therapeutic indication, (ii) pharmacological mechanism of action; (b) how does HC determine that a therapeutic product is safe; (c) what clinical and pre-clinical criteria are used by HC to make a safety assessment in regards to (i) vaccines, (ii) modified mRNA products, (iii) lipid nanotechnology, (iv) medications, (v) other biologics; (d) based on the pharmacological phase of the COVID-19 vaccines (i.e. from administration to spike protein expression), (i) are adverse events following immunizations adequately detected based on the Brighton Collaboration Criteria, (ii) what are the anticipated adverse events; (e) if the answer to (d)(i) is affirmative, how has this been confirmed; (f) what specific criteria were used to confirm the COVID-19 vaccines’ safety profile at their time of (i) approval, (ii) authorization; (g) based on the requirements in (b), (c) and (f), was that information adequate to categorically declare the safety of the COVID-19 vaccines for all cohorts at the time of their (i) approval, (ii) authorization; (h) does approval of a novel therapeutic product based on the Agile Licensing pathway require criteria that are equivalent to that required under C.08.001(2) of the Food and Drug Regulations; (i) if the answer to (g) or (h) is negative, who approved the messaging from government, public health officials, and other authorities that “COVID-19 vaccines do not get approval from HC unless they are safe” or that “all vaccines authorized in Canada are safe”; (j) how has safety of the COVID-19 vaccines been re-evaluated based on detected impurities, including (i) residual DNA, (ii) residual dsRNA, (iii) SV-40 enhancer sequence, (iv) endotoxins, (v) unknown peptides resulting from frameshifting; and (k) how has safety of the COVID-19 vaccine been evaluated based on remaining excessive intracellular N1-methylpseudouridine following degradation of the synthetic modified mRNA?