Q-3071 , 44th Parliament, 1st session November 22, 2021, to January 6, 2025

Regarding Health Canada’s (HC) review of the COVID-19 modRNA vaccine products: (a) did HC consider the specific nature of the nanotechnology of the lipid particles used for the modRNA vaccine delivery; (b) if affirmative to (a), what was their assessment; (c) why was the fact that modRNA vaccines contain nanotechnology omitted from the product monograph-label; (d) did HC assess the toxicity of pegylated nanoparticles, specifically the risk for complement activated related pseudoallergy (CARPA) with the lipid nanoparticles used in the mRNA vaccines; (e) if affirmative to (d), why was this not included in the product labelling; (f) if negative to (d) why wasn’t this assessed; (g) did HC assess the risk of toxicity due to the nanoformat of these vaccines; (h) if affirmative to (g), what was the assessment result; (i) if negative to (g), why not; (j) did HC assess the lipid nanoparticles as a novel excipient; (k) if affirmative to (j), what was the assessment; (l) if negative to (j), why not; (m) with respect to nanotechnology products and their unique properties and behaviors particularly in their application to the modRNA vaccines, did HC examine the (i) safety, (ii) effectiveness, (iii) risk to the environment and (iv) its specific regulatory status; (n) if affirmative to (m), (i) through to (iv), what were the assessment results; (o) if negative to (m), (i) through to (iv), why not; (p) how do established safe levels of DNA apply, (i) when using pegylated LNPs as a delivery system, (ii) when a product that contains pegylated LNPs requires repeated dosing; and (q) what assessment was performed to assess the risk of residual DNA when using pegylated LNPs as a delivery system in a vaccine which requires repeated dosing?