|
Q-1406
|
Wednesday, June 17, 2026 |
With regard to residual deoxyribonucleic acid in the final product of Pfizer-BioNTech COVID-19 vaccine (Comirnaty), and Health Canada's review of residual deoxyribonucleic acid associated with lipid nanoparticles, since December 1, 2019: (a) what records and data exist prior to the Interim Order concerning the presence of residual deoxyribonucleic acid in the Pfizer COVID-19 product, including, for each, record its title, date, author, recipient, and file or tracking number; (b) when and how did Health Canada first become aware of residual deoxyribonucleic acid, and what records document this; (c) when did Health Canada request information from Pfizer regarding residual deoxyribonucleic acid including reasons for this request, the dates, details of requests, and Pfizer's responses; (d) in the August 30, 2023 regulatory correspondence (New Drug Submission Control No. 276302), regarding the statement that certain elements "may be needed to maintain the structural integrity of the plasmid", (i) what elements were referred to, (ii) what is meant by "structural integrity," including whether it relates to the plasmid template, residual deoxyribonucleic acid, or another aspect, (iii) what evidence or analyses support this statement, (iv) which Health Canada unit authored or approved it, (v) what portions of the August 30, 2023 correspondence or related assessments were withheld or redacted, including the legal basis and reasons for each withholding; (e) what data or evidence did Pfizer provide Health Canada, and when, regarding residual deoxyribonucleic acid in Comirnaty, including levels, fragment size, characterization, manufacturing controls, specifications, batch variability, and impacts on product quality attributes; (f) what information and when did Pfizer provide data regarding the association of residual deoxyribonucleic acid captured within lipid nanoparticles including proportion encapsulated, mechanisms of association, interactions with lipids, biodistribution, persistence, and cellular interaction and possible deoxyribonucleic acid via lipid nanoparticle transfection; (g) what assessments has Health Canada conducted or commissioned to an independent agency regarding, (i) the impact of residual deoxyribonucleic acid on drug substance and product quality, stability, potency, and other critical quality attributes, and what were the outcomes, (ii) the quantity of residual deoxyribonucleic acid found in lipid nanoparticles versus naked deoxyribonucleic acid and what was the outcome, (iii) whether residual deoxyribonucleic acid functions solely as an impurity or has any role in formulation, structure, stability, or performance; (h) regarding the difference between naked deoxyribonucleic acid and deoxyribonucleic acid encapsulated in lipid nanoparticles, and the potential for either to persist in the body for prolonged periods, (i) what scientific evidence, studies, regulatory submissions, or assessments has Health Canada reviewed or relied upon, (ii) what information, analyses, or correspondence has Health Canada received from manufacturers or other regulators regarding the persistence, biodistribution, or clearance of deoxyribonucleic acid in naked form versus deoxyribonucleic acid protected within an lipid nanoparticle, (iii) what assessments, if any, has Health Canada conducted or commissioned regarding whether residual deoxyribonucleic acid is encapsulated within lipid nanoparticles, how much is encapsulated, and whether encapsulation changes persistence or biological interaction with cells, tissues, or the immune system; (i) is Health Canada aware of independent assessments of residual deoxyribonucleic acid, and, if so, which studies by date reviewed, title and author, and how did they inform Health Canada, and what steps did Health Canada take after examining these studies; (j) what communications or coordination have occurred between Health Canada and other regulators on residual deoxyribonucleic acid and its potential impacts including, (i) the United States' Food and Drug Administration, (ii) the European Medical Agency, (iii) the United Kingdom's Medicines and Healthcare products Regulatory Agency, (iv) Australia's Therapeutic Goods Administration, (v) any others; and (k) what internal scientific position has Health Canada adopted regarding residual deoxyribonucleic acid contained in this product with respect to it as solely an impurity or how it may contribute to formulation, stability, or performance, and what scientific evidence support that position? |
Awaiting response |
Monday, September 21, 2026 |
|
Q-144
|
Tuesday, June 10, 2025 |
With regard to Elections Canada, for each of the 2019, 2021 and 2025 general elections, in total and broken down by electoral district, for each part of the question: (a) how many applications for vote-by-mail ballots were (i) requested, (ii) denied; (b) how many vote-by-mail ballots were (i) sent out, (ii) received, (iii) counted, (iv) rejected; (c) what is the breakdown of each part of (b) by ballots sent to voters within Canada versus those outside of Canada; and (d) for Canadian citizens residing outside of Canada, what is the process for determining what riding they vote in, and how does Election Canada verify the accuracy of the information used to determine the riding?
|
Answered |
Monday, September 15, 2025 |
|
Q-142
|
Tuesday, June 10, 2025 |
With regard to Elections Canada and the 2025 general election: (a) what is the full breakdown of the processing of special ballots, including how and when they are counted; (b) does Elections Canada record a distinction between special ballots in person and special ballots used to vote by mail; (c) what is the full breakdown of the processing of advance polling and the counting of those ballots, including the transportation of ballot boxes used in advance polling locations to their storage and counting locations; (d) who processes vote-by-mail ballot requests and what are the criteria to accept or reject requests to vote by mail; (e) where are vote-by-mail ballots counted; (f) is Elections Canada aware of any instances of voters being told at the poll that they had already voted by mail-in ballot when they had not, and, if so, how many instances are they aware of, broken down by riding;
(g) what is the process for poll workers to notify Elections Canada when the situation outlined in (f) occurs; (h) how does Elections Canada define (i) voting kit, (ii) special ballot, (iii) vote-by-mail, and have any of these definitions changed in the past 10 years, and, if so, what are the details, including the date of the change and the previous definition; and (i) on what date will the "raw data" of the 2025 Canadian federal election be made available online?
|
Answered |
Monday, September 15, 2025 |
