Speech (House debate)

{
    "time": "2024-06-19 17:55:00",
    "attribution": {
        "en": "Mr. Yasir Naqvi (Parliamentary Secretary to the Minister of Health, Lib.)",
        "fr": "M. Yasir Naqvi (secr\u00e9taire parlementaire du ministre de la Sant\u00e9, Lib.)"
    },
    "content": {
        "en": "<p data-HoCid=\"8512611\">Mr. Speaker, the health and safety of Canadians are Health Canada\u2019s top priorities, and the department exercises stringent regulatory oversight over vaccines. Before any of the COVID-19 vaccines were approved in Canada, the department conducted rigorous scientific review of the extensive data regarding the vaccines\u2019 safety, efficacy and quality, including results of pre-clinical and clinical studies, details on manufacturing processes, and information on adverse events following immunization. An authorization was only issued when the benefits of any of the COVID-19 vaccines outweighed the risks of their use, thereby allowing the use of \u201csafe and effective\u201d in describing the authorized vaccine preparations.</p>\n<p data-HoCid=\"8512612\">The COVID-19 vaccines and treatments portal, https://covid-vaccine.canada.ca/, contains the summary basis of decision for each of the authorized COVID-19 vaccines. Please note that biopharmaceutic studies and associated analytical methods are proprietary and cannot be disclosed. All COVID-19 vaccines authorized by Health Canada under the interim order met the requirements of section C.08.001(2) of the food and drug regulations (2)(g) and (2)(h) for safety and efficacy. Terms and conditions were imposed upon the authorization with respect to quality, clinical, labelling, and risk management plan requirements. This process has allowed Health Canada to assess information submitted by the manufacturer as it became available during the product life cycle to ensure that the benefits of the vaccines continued to outweigh the risks. Additional safety and effectiveness data generated post-approval continue to support Health Canada's original decision.</p>\n<p data-HoCid=\"8512613\">Lastly, the mRNA COVID-19 vaccines authorized by Health Canada met the requirements of section C.04.015 of the food and drug regulations. However, the lot evaluation group assigned to mRNA vaccines, as part of the lot release program and protocols of testing submitted by the manufacturers, is proprietary and cannot be disclosed.</p>",
        "fr": "<p data-HoCid=\"8512611\">Monsieur le Pr\u00e9sident, la sant\u00e9 et la s\u00e9curit\u00e9 des Canadiens sont les priorit\u00e9s absolues de Sant\u00e9 Canada, et le Minist\u00e8re exerce une surveillance r\u00e9glementaire stricte sur les vaccins. Avant que ls vaccins contre la COVID-19 n\u2019aient \u00e9t\u00e9 approuv\u00e9s au Canada, le Minist\u00e8re a proc\u00e9d\u00e9 \u00e0 un examen scientifique rigoureux des nombreuses donn\u00e9es concernant leur innocuit\u00e9, leur efficacit\u00e9 et leur qualit\u00e9, y compris des r\u00e9sultats d'\u00e9tudes pr\u00e9cliniques et cliniques, des d\u00e9tails sur les processus de fabrication et des informations sur les effets ind\u00e9sirables suivant la vaccination. L\u2019autorisation est accord\u00e9e seulement lorsque les avantages de tout vaccin contre la COVID-19 l\u2019emportent sur les risques potentiels de son utilisation, ce qui permet d\u2019affirmer que les pr\u00e9parations vaccinales autoris\u00e9es sont \u00ab s\u00fbres et efficaces \u00bb.</p>\n<p data-HoCid=\"8512612\">Le portail des vaccins et traitements contre la COVID-19, que l\u2019on peut consulter \u00e0 l\u2019adresse https://vaccin-covid.canada.ca/, contient le r\u00e9sum\u00e9 des motifs de d\u00e9cision pour chacun des vaccins autoris\u00e9s contre la COVID-19. Veuillez noter que les \u00e9tudes biopharmaceutiques et les m\u00e9thodes analytiques associ\u00e9es sont brevet\u00e9es et ne peuvent \u00eatre divulgu\u00e9es. Tous les vaccins contre la COVID-19 autoris\u00e9s par Sant\u00e9 Canada en vertu de l'arr\u00eat\u00e9 d'urgence r\u00e9pondaient aux exigences des alin\u00e9as g) et h) du paragraphe C.08.001(2) du R\u00e8glement sur les aliments et drogues en mati\u00e8re de s\u00e9curit\u00e9 et d'efficacit\u00e9. Des modalit\u00e9s et conditions ont \u00e9t\u00e9 impos\u00e9es lors de l'autorisation en ce qui concerne les exigences en mati\u00e8re de qualit\u00e9, cliniques, d'\u00e9tiquetage et du plan de gestion des risques. Ce processus a permis \u00e0 Sant\u00e9 Canada d'\u00e9valuer les informations soumises par le fabricant au fur et \u00e0 mesure qu'elles sont devenues disponibles pendant le cycle de vie du produit afin de garantir que les avantages des vaccins continuaient de l'emporter sur les risques. Les donn\u00e9es suppl\u00e9mentaires sur l'innocuit\u00e9 et l'efficacit\u00e9 g\u00e9n\u00e9r\u00e9es apr\u00e8s l'approbation continuent de soutenir la d\u00e9cision initiale de Sant\u00e9 Canada.</p>\n<p data-HoCid=\"8512613\">Enfin, les vaccins \u00e0 ARNm contre la COVID-19 autoris\u00e9s par Sant\u00e9 Canada r\u00e9pondaient aux exigences de l'article C.04.015 du R\u00e8glement sur les aliments et drogues. Cependant, le groupe d'\u00e9valuation des lots affect\u00e9 aux vaccins \u00e0 ARNm dans le cadre du programme d\u2019autorisation de mise en circulation des lots de drogues et des protocoles de tests soumis par les fabricants est exclusif et ne peut \u00eatre divulgu\u00e9.</p>"
    },
    "url": "/debates/2024/6/19/yasir-naqvi-2/",
    "politician_url": "/politicians/yasir-naqvi/",
    "politician_membership_url": "/politicians/memberships/4647/",
    "procedural": false,
    "source_id": "p8512611",
    "h1": {
        "en": "Routine Proceedings",
        "fr": "Affaires Courantes"
    },
    "h2": {
        "en": "Questions on the Order Paper",
        "fr": "Questions au Feuilleton"
    },
    "h3": {
        "en": "Question No.2652\u2014",
        "fr": "Question no 2652 \u2014"
    },
    "document_url": "/debates/2024/6/19/",
    "related": {
        "document_speeches_url": "/speeches/?document=%2Fdebates%2F2024%2F6%2F19%2F"
    }
}