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.
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.
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.
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.
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.
As to Comirnaty’s 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.
As to Spikevax’s 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.
Part (d) is not applicable. Please see response to part (b).