Speech (House debate)

{
    "time": "2024-01-29 16:30:00",
    "attribution": {
        "en": "Hon. Mark Holland (Minister of Health, Lib.)",
        "fr": "L\u2019hon. Mark Holland (ministre de la Sant\u00e9, Lib)"
    },
    "content": {
        "en": "<p data-HoCid=\"8166178\">Mr. Speaker, with regard to part (a), yes, the non-clinical studies submitted to Health Canada to support the approval of the COVID-19 vaccines were conducted in accordance with the ICH standards. In particular, the ICH safety guideline S5(R3), detection of reproductive and developmental toxicity for human pharmaceuticals, has specific requirements for the design and conduct of developmental and reproductive toxicity studies for vaccines. This guideline provides information on animal species selection as well as dose selection and study design for vaccines against infectious diseases.</p>\n<p data-HoCid=\"8166179\">Health Canada is responsible for the regulatory authorization of vaccines, which encompasses the review and assessment of various studies to ensure the safety and efficacy of vaccines. The National Advisory Committee on Immunization, NACI, primarily focuses on analyzing data from human clinical trials to provide vaccine safety recommendations. NACI's role is not directly involved in the regulatory authorization process or in the initial review of safety and efficacy studies.</p>\n<p data-HoCid=\"8166180\">With regard to part (b), yes, DART studies were required as part of the regulatory evaluation of COVID-19 vaccines. These studies were conducted in accordance with ICH guidelines in S5(R3). These studies were submitted for regulatory review and supported the approval of the COVID-19 vaccines. The outcomes of these studies were included in the relevant documents prepared and published by Health Canada to inform the public, health care professionals and researchers. This information can be found under each specific product. For Comirnaty, from Pfizer-BioNTech, the product monograph is at https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf and the summary basis of decision is at https://covid-vaccine.canada.ca/info/SBD00510-comirnaty-en.html. For Spikevax, from Moderna, the product monograph is at https://covid-vaccine.canada.ca/info/pdf/covid-19-vaccine-moderna-pm-en.pdf and the summary basis of decision is at https://covid-vaccine.canada.ca/info/SBD00511-spikevax-en.html.</p>\n<p data-HoCid=\"8166181\">It should be noted that the vaccine manufacturers did not seek an indication for use in pregnant and lactating women and that the product monographs included statements about the uncertainty regarding safety and efficacy in pregnancy and lactation. At the time of approval, there was limited experience with the use of COVID-19 vaccines in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo or fetal development, parturition or postnatal development, and human randomized clinical trials were not submitted for regulatory evaluation.</p>\n<p data-HoCid=\"8166182\">With regard to part (c), as indicated above, DART studies were required as part of the regulatory evaluation of COVID-19 vaccines. DART studies are required to detect any effects of the vaccine within a complete reproductive cycle as relevant to humans, from initial conception to reproductive capacity. No vaccine-related adverse effects on female fertility, fetal development or postnatal development were reported in the studies for the vaccines. Excerpts from the product monographs are included below.</p>\n<p data-HoCid=\"8166183\">As to Comirnaty\u2019s reproductive and developmental toxicology, in a reproductive and developmental toxicity study, 30 micrograms per animal, or 0.06 millilitres of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid, mRNA, and other ingredients included in a single human dose, of Comirnaty was administered to female rats by the intramuscular route on four occasions: 21 and 14 days prior to mating and on gestation days nine and 20. No vaccine-related adverse effects on female fertility, fetal development or postnatal development were reported in the study.</p>\n<p data-HoCid=\"8166184\">As to Spikevax\u2019s reproductive and developmental toxicology, in a pre- and postnatal developmental toxicity study, 0.2 millilitres of a vaccine formulation containing the same quantity of mRNA, 100 micrograms, and other ingredients included in a single human dose of Spikevax was administered to female rats by the intramuscular route on four occasions: 28 and 14 days prior to mating and on gestation days one and 13. No vaccine-related adverse effects on female fertility, fetal development or postnatal development were reported in the study.</p>\n<p data-HoCid=\"8166185\">Part (d) is not applicable. Please see response to part (b).</p>",
        "fr": "<p data-HoCid=\"8166178\">Monsieur le Pr\u00e9sident, oui, les \u00e9tudes non cliniques soumises \u00e0 Sant\u00e9 Canada pour \u00e9tayer l\u2019approbation des vaccins contre la COVID-19 ont \u00e9t\u00e9 men\u00e9es conform\u00e9ment aux normes de l\u2019ICH. En particulier, la ligne directrice de s\u00e9curit\u00e9 S5(R3) de l\u2019ICH, sur la d\u00e9tection de la toxicit\u00e9 pour la reproduction et le d\u00e9veloppement des produits pharmaceutiques humains, contient des exigences pr\u00e9cises pour la conception et la r\u00e9alisation d\u2019\u00e9tudes de toxicit\u00e9 pour l\u2019\u00e9laboration et la reproduction des vaccins. Cette ligne directrice fournit des renseignements sur la s\u00e9lection des esp\u00e8ces animales ainsi que sur la s\u00e9lection des doses et la conception des \u00e9tudes pour les vaccins contre les maladies infectieuses.</p>\n<p data-HoCid=\"8166179\">Sant\u00e9 Canada est responsable de l\u2019homologation des vaccins, ce qui comprend l\u2019examen et l\u2019\u00e9valuation de diverses \u00e9tudes, afin de garantir l\u2019innocuit\u00e9 et l\u2019efficacit\u00e9 des vaccins. Le Comit\u00e9 consultatif national de l\u2019immunisation se concentre principalement sur l\u2019analyse des donn\u00e9es issues des essais cliniques sur l\u2019humain afin de formuler des recommandations sur l\u2019innocuit\u00e9 des vaccins. Le r\u00f4le du Conseil n\u2019est pas de participer directement au processus d\u2019homologation ni \u00e0 l\u2019examen initial des \u00e9tudes sur l\u2019innocuit\u00e9 et l\u2019efficacit\u00e9 des vaccins.</p>\n<p data-HoCid=\"8166180\">Pour ce qui est de la partie b), oui, des \u00e9tudes DART ont \u00e9t\u00e9 exig\u00e9es pour l\u2019\u00e9valuation r\u00e9glementaire des vaccins contre la COVID-19. Ces \u00e9tudes ont \u00e9t\u00e9 men\u00e9es conform\u00e9ment aux lignes directrices S5(R3) de l\u2019ICH. Elles ont \u00e9t\u00e9 soumises \u00e0 l\u2019examen des autorit\u00e9s r\u00e9glementaires et elles ont men\u00e9 \u00e0 l\u2019homologation des vaccins contre la COVID-19. Les r\u00e9sultats de ces \u00e9tudes ont \u00e9t\u00e9 inclus dans les documents pr\u00e9par\u00e9s et publi\u00e9s par Sant\u00e9 Canada dans le but d\u2019informer le public, les professionnels de la sant\u00e9 et les chercheurs. Ces renseignements sont disponibles pour chaque produit: La monographie du Comirnaty, de Pfizer-BioNTech, se trouve au https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-fr.pdf, et le sommaire des motifs de d\u00e9cision se trouve au https://covid-vaccine.canada.ca/info/SBD00510-comirnaty-fr.html. La monographie du Spikevax, de Moderna, se trouve au https://covid-vaccine.canada.ca/info/pdf/covid-19-vaccine-moderna-pm-fr.pdf, et le sommaire des motifs de d\u00e9cision, au https://covid-vaccine.canada.ca/info/SBD00511-spikevax-fr.html.</p>\n<p data-HoCid=\"8166181\">Il convient de noter que les fabricants de vaccins n\u2019ont pas cherch\u00e9 \u00e0 obtenir une indication pour l\u2019utilisation chez les femmes enceintes et qui allaitent et que les monographies comprenaient des d\u00e9clarations sur l\u2019incertitude concernant l\u2019innocuit\u00e9 et l\u2019efficacit\u00e9 pendant la grossesse et l\u2019allaitement. Au moment de l\u2019homologation, l\u2019exp\u00e9rience de l\u2019utilisation des vaccins contre la COVID-19 chez les femmes enceintes \u00e9tait limit\u00e9e. Les \u00e9tudes animales n\u2019indiquent pas d\u2019effets nocifs directs ou indirects sur la grossesse, le d\u00e9veloppement de l\u2019embryon et du f\u0153tus, la parturition ou le d\u00e9veloppement postnatal, et aucun essai clinique randomis\u00e9 sur l\u2019humain n\u2019a \u00e9t\u00e9 soumis \u00e0 l\u2019\u00e9valuation r\u00e9glementaire.</p>\n<p data-HoCid=\"8166182\">En ce qui concerne la partie c), comme je le disais plus t\u00f4t, des \u00e9tudes DART ont \u00e9t\u00e9 exig\u00e9es dans le cadre de l\u2019\u00e9valuation r\u00e9glementaire des vaccins contre la COVID-19. Les \u00e9tudes DART sont n\u00e9cessaires pour d\u00e9tecter tout effet du vaccin au cours d\u2019un cycle de reproduction complet chez l\u2019humain, soit de la conception initiale \u00e0 la capacit\u00e9 de reproduction. Aucun effet ind\u00e9sirable li\u00e9 au vaccin sur la fertilit\u00e9 des femelles, le d\u00e9veloppement du f\u0153tus ou le d\u00e9veloppement postnatal n\u2019a \u00e9t\u00e9 signal\u00e9 dans les \u00e9tudes portant sur les vaccins. Voici ce qu\u2019on peut lire dans les monographies des deux produits:</p>\n<p data-HoCid=\"8166183\">Comirnaty: Au cours d\u2019une \u00e9tude sur la toxicit\u00e9 pour la reproduction et le d\u00e9veloppement, 30 mcg (0,06 ml d\u2019une pr\u00e9paration du vaccin qui renfermait la m\u00eame quantit\u00e9 d\u2019acide ribonucl\u00e9ique messager [ARNm] \u00e0 nucl\u00e9oside modifi\u00e9 et des autres ingr\u00e9dients compris dans une dose unique pour usage humain) de COMIRNATY ont \u00e9t\u00e9 administr\u00e9s \u00e0 des rates par voie intramusculaire \u00e0 quatre reprises: 21 et 14 jours avant l\u2019accouplement, puis aux jours 9 et 20 de la gestation. Aucune manifestation ind\u00e9sirable li\u00e9e au vaccin sur les plans de la fertilit\u00e9 des femelles, du d\u00e9veloppement f\u0153tal ou du d\u00e9veloppement postnatal n\u2019a \u00e9t\u00e9 signal\u00e9e pendant l\u2019\u00e9tude.</p>\n<p data-HoCid=\"8166184\">Spikevax: Dans une \u00e9tude de toxicit\u00e9 pr\u00e9-natale et post-natale pour le d\u00e9veloppement, un volume de 0,2 ml d\u2019une formulation vaccinale contenant la m\u00eame quantit\u00e9 d\u2019ARNm (100 mcg) et d\u2019autres ingr\u00e9dients que celle d\u2019une dose unique de SPIKEVAX chez l\u2019humain a \u00e9t\u00e9 administr\u00e9 \u00e0 des rates, par voie intramusculaire, \u00e0 quatre reprises: 28 et 14 jours avant l\u2019accouplement, et aux jours 1 et 13 de la gestation. Aucun effet li\u00e9 au vaccin sur la fertilit\u00e9 des femelles, le d\u00e9veloppement f\u0153tal ou le d\u00e9veloppement postnatal n\u2019a \u00e9t\u00e9 signal\u00e9 dans le cadre de l\u2019\u00e9tude.</p>\n<p data-HoCid=\"8166185\">La partie d) est sans objet. Voir la r\u00e9ponse au point b).</p>"
    },
    "url": "/debates/2024/1/29/mark-holland-9/",
    "politician_url": "/politicians/mark-holland/",
    "politician_membership_url": "/politicians/memberships/4263/",
    "procedural": false,
    "source_id": "p8166178",
    "h1": {
        "en": "Routine Proceedings",
        "fr": "Affaires Courantes"
    },
    "h2": {
        "en": "Questions on the Order Paper",
        "fr": "Questions au Feuilleton"
    },
    "h3": {
        "en": "Question No.2162\u2014",
        "fr": "Question no 2162 \u2014"
    },
    "document_url": "/debates/2024/1/29/",
    "related": {
        "document_speeches_url": "/speeches/?document=%2Fdebates%2F2024%2F1%2F29%2F"
    }
}