With regard to the review by Health Canada (HC), the Public Health Agency of Canada (PHAC), or the National Advisory Committee on Immunization, of a pre-print study posted on October 15, 2023 of which six authors are associated with the US Food and Drug Administration that found "a new signal was detected for seizures-convulsions after BNT162b2 (2-4 years) and mRNA1273 COVID-19 vaccinations (2-5 years),": (a) which federal health agency, organization, committee or department(s) or outsourced contracted firm is responsible for reviewing or identifying studies such as the pre-print titled "Safety of Monovalent BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and NVX-CoV2373 (Novavax) COVID- 19 Vaccines in US Children Aged six months to 17 years;"; (b) has any federal health agency, organization, committee, department(s) or outsourced contracted firm reviewed or been made aware of the forementioned study or learned about the new safety signal of seizures/convulsions among children following monovalent COVID-19 vaccine; (c) if the answer to (b) is affirmative, has HC or any federal health agency, organization or committee issued any statement to the Canadian public or any communication to the provinces or the medical community to create awareness of this new safety signal; (d) if the answer to (c) is affirmative, what was the statement or communication provided; (e) if the answer to (c) is negative, why not; (f) how many episodes of seizures-convulsions have been reported in children under 17 years in Canadian Adverse Events following Immunization Surveillance System records, from (i) May 1, 2021 to April 30, 2023, (ii) May 1, 2018 to April 30, 2020; (g) what provincial and territory data is the federal government relying upon to monitor risk of seizures and convulsions in this cohort in real time; (h) how far out is the government monitoring this data (e.g. 28 days post-vaccine, up to 3 months, 6 months, 12 months, beyond 12 months post-COVID-19 immunization); (i) what are the Canadian government's threshold values for marking the likelihood of a vaccine serious adverse event as transitioning from an extremely rare, to a rare occurrence, and from a rare to a common occurrence; (j) what is the threshold whereby a safety signal of seizures or convulsions would shut down the mRNA vaccine program in children under the age of 17 years; (k) why are children's seizures-convulsions not listed on HC's webpage denoted to children's side-effects which was last updated on October 27, 2023; (l) with real-time monitoring, what other safety signals has HC, the PHAC or any other federal agency or department discovered post-mRNA vaccine injection for (i) children under age 5 years, (ii) children 6-17 years, (iii) persons 18-25 years, (iv) persons 26-35 years; (m) is HC receiving any data directly from provincial datasets to monitor increased usage of provincial health systems by Canadian children post-vaccination; (n) has any federal health agency or entity such as the Canadian Institute for Health Information or outsourced contractor tracked the number of episodes of myocarditis and pericarditis in young persons under the age of 35, post-vaccination, using billing or ICD-10 data from physicians and hospitals across Canada both before and after the COVID-19 injections had commenced; (o) if the answer to (n) is affirmative, (i) for what period of time post-immunization are they tracked, (ii) is the rate of myocarditis and pericarditis in persons under 35 years following the roll-out of the COVID-19 mRNA vaccines greater or less than the baseline rates of myocarditis and pericarditis from 2016-2019; (p) if there were deviations from the baseline found in (o)(ii), by how much did this occur and by which method has the determination of any difference, or lack thereof, been made; (q) if the answer to (n) is negative, why is this data not being tracked; and (r) when examining the risk-of-harm to benefit ratio of the COVID-19 mRNA products and when considering the combination of serious adverse events such as seizures-convulsions, myocarditis and pericarditis in young persons, what is the combined threshold of serious adverse events by which mRNA products would no longer be available to (i) children under the age of 5 years, (ii) children 6-17 years old, (iii) persons 18-25 years old, (iv) persons 26-35 years old, and who determines these thresholds, when, and based on what data?
In the House of Commons on June 17th, 2024. See this statement in context.