PDF file: 441-2918_vaccine_toxicity_PEG_LNPs.pdf OPQ ID: 441-2918 Session: 441 Question number: Q-2918 Sessional paper: Q-2918 Title: vaccine toxicity, PEG, LNPs Short description: Topic: vaccines Identified concern: Keywords: Agencies: HC, PHAC Date asked: 2024-06-18 Date tabled: Submitted by: Mr. Falk (Provencher) Reply by: Minister of Health Responded by: Mr. Yasir Naqvi Pages: 4 Status: not processed Alert: yellow Questions asked: 17 Questions answered: 2 Percent responded: 12% Referenced sources: Canada.ca, COVID-19 vaccines and treatments portal Referenced links: https://bit.ly/36xea3C, http://bit.ly/30LJM2z, https://covid-vaccine.canada.ca/.Following Official link: https://www.google.com/search?q=Q-2918+ourcommons.ca PDF URL: https://ivim.ca/foi/opq/r/441-2918_vaccine_toxicity_PEG_LNPs.pdf TXT URL: https://ivim.ca/foi/opq/r/441-2918.txt Original filename: Q-2918_HC vaccine toxicity, PEG, LNPs.pdf Local source path: C:\Users\Dmitry\Documents\CODES\OPQ-App\data-raw\OPQ\ALL OPQ TO DATE\2022\Q-2918_HC vaccine toxicity, PEG, LNPs.pdf Machine extracted at: 2026-06-30 12:58:27 References / links: - https://bit.ly/36xea3C - http://bit.ly/30LJM2z - https://covid-vaccine.canada.ca/.Following - Canada.ca - COVID-19 vaccines and treatments portal Machine notes: (none) Question text preview: With regard to 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 the answer to (a) is affirmative, 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 pseudo allergy (CARPA) with the lipid nanoparticles used in the mRNA vaccines; (e) if the answer to (d) is affirmative, why was this not included in the product labelling; (f) if the answer to (d) is negative, why wasn't this assessed; (g) did HC assess the risk of toxicity due to the nanoformat of these vaccines; (h) if the answer to (g) is affirmative, what was the assessment result; (i) if the answer to (g) is negative, why not; (j) did HC assess the lipid nanoparticles as a novel excipient; (k) if the answer to (j) is affirmative, what was the assessment; (l) if the answer to (j) is negative, 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 (i) the safety, (ii) the effectiveness, (iii) the risk to the environment, (iv) its specific regulatory status; (n) if the answers to (m)(i) to (m)(iv) is affirmative, what were the assessment results; (o) if the answers to (m)(i) through (m)(iv) is negative, 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?