Alert level: red OPQ: Q-464 Session: 451 Suggested file name: clinical_trial_data Tabled on: Agencies: PHAC|HC Estimated questions: 9 Estimated responses: 0 Original filename: Q-464, clinical trial data.pdf External links / references: https://bit.ly/3EH07IB https://bit.ly/3lo1svI https://bit.ly/3GFvDHE https://bit.ly/3uEsNQF https://bit.ly/3GNlhWg https://covid-vaccine.canada.ca/info/post-authorization-activity-table.html?linkID=SBD00510 https://health-infobase.canada.ca/covid-19/vaccine-safety/ https://vaccin- https://renseignements-cliniques.canada.ca/recherche/ci- https://vaccin-covid.canada.ca/comirnaty/details- https://covid-vaccine.canada.ca/info/sommaire-motif-decision- https://covid-vaccine.canada.ca/info/tableau- https://sante-infobase.canada.ca/covid-19/securite-vaccins/ Extracted PDF text preview: ORDER/ADDRESS OF THE HOUSE OF COMMONS ORDRE/ADRESSE DE LA CHAMBRE DES COMMUNES Q-464 Mr. Carrie (Oshawa) Apr 4, 2022 / Le 4 avr. 2022 RETURN BY THE LEADER OF THE GOVERNMENT IN THE HOUSE OF COMMONS DÉPÔT DU LEADER DU GOUVERNEMENT À LA CHAMBRE DES COMMUNES Mr. Lamoureux PRINT NAME OF SIGNATORY INSCRIRE LE NOM DU SIGNATAIRE SIGNATURE MINISTER OR PARLIAMENTARY SECRETARY MINISTRE OU SECRÉTAIRE PARLEMENTAIRE May 20, 2022 / Le 20 mai 2022 (TABLED FORTHWITH /DÉPOSÉ AUSSITÔT) INQUIRY OF MINISTRY DEMANDE DE RENSEIGNEMENT AU GOUVERNEMENT PREPARE IN ENGLISH AND FRENCH MARKING "ORIGINAL TEXT" OR "TRANSLATION" PRÉPARER EN ANGLAIS ET EN FRANÇAIS EN INDIQUANT "TEXTE ORIGINAL" OU "TRADUCTION" QUESTION NO./NO DE LA QUESTION Q-464 BY / DE Mr. Carrie (Oshawa) DATE April 4, 2022 Reply by the Minister of Health Réponse de la ministre de la Santé Signed by Mr. van Koeverden PRINT NAME OF SIGNATORY INSCRIRE LE NOM DU SIGNATAIRE SIGNATURE MINISTER OR PARLIAMENTARY SECRETARY MINISTRE OU SECRÉTAIRE PARLEMENTAIRE QUESTION With regard to data held by the government related to Pfizer’s COVID-19 vaccine: (a) on what date and how was the government informed of the clinical trial data of the vaccine that was published on November 4, 2021, in the New England Journal of Medicine; (b) on what date and how was the government informed of the adverse reactions and side effects of the vaccine as mentioned in the documents released in accordance with the order made by Justice Mark Pittman of the United States District Court for the Northern District of Texas on January 6, 2022; and (c) is the government aware of any additional data that will be released by Pfizer this year, and if so, what are the details, including the (i) date the government became aware of the data, (ii) date the data will become public, (iii) summary of data findings? REPLY / RÉPONSE ORIGINAL TEXT TRANSLATION TEXTE ORIGINAL TRADUCTION Health Canada Health Canada has authorized several COVID-19 vaccines for use in Canada. Each of these underwent a careful scientific review, and met our standards for safety, efficacy and quality. Information about all of the authorized vaccines can be found on the COVID-19 vaccines and treatments portal: https://bit.ly/3EH07IB. For each of the vaccines which have been authorized, you can access detailed information such as:  The product monograph, which is the prescribing information for both consumers and healthcare professionals (manufacturer insert)  The summary basis of decision, which provides a detailed overview of the data considered by Health Canada  The terms and conditions placed on the authorizations, which are the requirements for further data submission that manufacturers are required to meet Note that information in the portal is being updated regularly and can be found here: https://bit.ly/3lo1svI (a) The November 4, 2021 article in the New England Journal of Medicine article referred to 6 months follow-up clinical trial data for the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine. The drug manufacturer of the BNT162b2 mRNA COVID-19 vaccine (Pfizer Canada/BioNTech) included this information with their New Drug Submission which was filed to Health Canada on June 10, 2021. All New Drug Submissions must contain information and data about the drug’s safety, efficacy and quality. This typically includes preclinical data (animal studies), clinical data (human studies) and details regarding the chemistry and manufacturing, packaging and labelling of the new drug. A 6 month follow- up for a vaccine is generally sufficient to provide an insight on vaccine safety allowing Health Canada to properly assess the potential benefits versus the risks. You can access the clinical study reports related to the approval of Pfizer/BioNTech Comirnaty vaccine on Health Canada’s Public Release of Clinical Information website (https://bit.ly/3GFvDHE). Here you can find specific details related to various aspects of the review, including the summaries of the clinical efficacy and safety. X - 2 - For your convenience, some additional useful links are found here: Product Monograph: Comirnaty: https://bit.ly/3uEsNQF Summary Basis of Decision for Comirnaty https://bit.ly/3GNlhWg (b) Health Canada would require more information to identify the specific document referenced in the question. However, similar to the US FDA, Health Canada receives reports of adverse events following immunization (AEFI) from all manufacturers of COVID-19 vaccines. As dictated by the terms and conditions, manufacturers prioritize and submit AEFI reports to Health Canada through Summary Safety Reports and Periodic Safety Update Reports (PSUR). To date, Pfizer has provided Health Canada with 2 PSURs and 15 (MSR) from Pfizer:  PSUR#1 submitted on 2021-08-26  PSUR#2 submitted on 2022-03-08  MRS#1 was submitted on 2021-01-15  MSR#2 was submitted on 2021-02-15  MSR#3 was submitted on 2021-03-16  MSR#4 was submitted on 2021-04-15  MSR#5 was submitted on 2021-05-14  MSR#6 was submitted on 2021-06-15  MSR#7 was submitted on 2021-07-16  MSR#8 was submitted on 2021-08-13  MSR#9 was submitted on 2021-09-15  MSR#10 was submitted on 2021-10-15  MSR#11 was submitted on 2021-11-16  MSR#12 was submitted on 2021-12-15  MSR#13 was submitted on 2022-01-14  MSR#14 was submitted on 2022-02-02  MSR#15 was submitted on 2021-03-14 Information about post-authorization activity for the Pfizer/BioNTech COVID-19 vaccine can be found here: https://covid-vaccine.canada.ca/info/post-authorization-activity-table.html?linkID=SBD00510. In addition, since the start of the pandemic HC has worked with and continues to work with international regulatory partners to share information on the COVID-19 vaccine reported adverse events. HC has worked with PHAC to publish a weekly summary of the AEFIs reported in Canada since January 8, 2021, which can be found here https://health-infobase.canada.ca/covid-19/vaccine-safety/ (c) Health Canada is not aware of any additional data that will be released by Pfizer this year. As part of our transparency and openness commitments, Health Canada will be releasing data as they become available from clinical studies or monitoring activities. INQUIRY OF MINISTRY DEMANDE DE RENSEIGNEMENT AU GOUVERNEMENT PREPARE IN ENGLISH AND FRENCH MARKING "ORIGINAL TEXT" OR "TRANSLATION" PRÉPARER EN ANGLAIS ET EN FRANÇAIS EN INDIQUANT "TEXTE ORIGINAL" OU "TRADUCTION" QUESTION NO./NO DE LA QUESTION Q-464 BY / DE M. Carrie (Oshawa) DATE Le 4 avril 2022 Reply by the Minister of Health Réponse de la ministre de la Santé Signé par M. van Koeverden PRINT NAME OF SIGNATORY INSCRIRE LE NOM DU SIGNATAIRE SIGNATURE MINISTER OR PARLIAMENTARY SECRETARY MINISTRE OU SECRÉTAIRE PARLEMENTAIRE QUESTION En ce qui concerne les données que possède le gouvernement sur le vaccin de Pfizer contre la COVID-19 : a) à quelle date et comment le gouvernement a-t-il été informé des données d’essais cliniques qui ont été publiées le 4 novembre 2021 dans le New England Journal of Medicine; b) à quelle date et comment le gouvernement a-t-il été informé des effets indésirables et des effets secondaires du vaccin, mentionnés dans les documents divulgués conformément à l’ordonnance prise par le juge Mark Pittman de la Cour fédérale du district Nord du Texas, le 6 janvier 2022; c) le gouvernement est-il au courant de toutes données supplémentaires que publiera Pfizer cette année et, le cas échéant, quels en sont les détails, y compris (i) la date à laquelle le gouvernement a été informé des données, (ii)