KAWARTHA LAKES-Health Canada received a submission from Pfizer-BioNTech seeking authorization for the use of its Comirnaty COVID-19 vaccine in children 5 to 11 years of age today. As with all COVID-19 vaccines, the Department says it will prioritize the review of this submission.
This is the first submission Health Canada has received for the use of a COVID-19 vaccine in this younger age group. The doses will be about one-third the size of those given to adults and those aged 12 and up.
“Authorization decisions will be made based on the overall benefits and risks, taking into account the totality of the data available at the time of submission including both the results that have been provided in the submission and the current knowledge related to the virus and disease, which will need to be continually monitored following approval.” Andre Gagnon, Health Canada Told Kawartha 411 News. “Current knowledge will be informed by several sources including, but not limited to, the scientific literature, public health and surveillance data and collaborative interactions with our international regulatory partners.”
Health Canada officials admit the risk of COVID-19 to children is very low.
“In terms of the younger age group, children generally do not get seriously ill, but they can,” Gagnon told Kawartha 411. “While they are less likely than adults to become severely ill, there have still been more than 1,700 children and youth (aged 0-19 years) hospitalized, 196 admitted to an intensive care unit, and 17 deaths.” (In the 18 months since the pandemic began)
In 2019, 20 children in Canada died of the flu/pneumonia in 12 months according to Stats Canada. The figures can be found here:https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1310039401&pickMembers%5B0%5D=2.21&pickMembers%5B1%5D=3.1&cubeTimeFrame.startYear=2018&cubeTimeFrame.endYe
A recent peer-reviewed study concluded the benefit does not outweigh the risk. It found the bulk of the official COVID-19-attributed deaths per capita occur in the elderly with high comorbidities, and the COVID-19 attributed deaths per capita are negligible in children.
“Clinical trials for these inoculations were very short-term (a few months), had samples not representative of the total population, and for adolescents/children, had poor predictive power because of their small size. Further, the clinical trials did not address changes in biomarkers that could serve as early warning indicators of elevated predisposition to serious diseases. Most importantly, the clinical trials did not address long-term effects that, if serious, would be borne by children/adolescents for potentially decades.” stated the authors.
Here is a link to the full study:https://www.sciencedirect.com/science/article/pii/S221475002100161X
Health Canada says only vaccines that are proven to be safe, effective and of high quality are authorized for use in Canada and the COVID-19 vaccines have been rigorously tested during their development and then carefully reviewed by Health Canada, including safety data, and data from other regulatory partners, including the United States.
“This information is taken into consideration as we examine and assess any new safety concerns. Should new safety information become available, Health Canada will assess it and take appropriate action. This could include communicating new risks to Canadians and healthcare providers or changing the recommended use of the product.” says Gagnon.
According to the federal government there have been almost 1,000 cases of heart inflammation called myocarditis/pericarditis linked to the COVID vaccine in Canada with young people being impacted disproportionately.
Of the myocarditis/pericarditis reports:
- 540 reports followed vaccination with a Pfizer-BioNTech Comirnaty COVID-19 vaccine, 348 followed vaccination with a Moderna Spikevax COVID-19 vaccine, 20 followed vaccination with an AstraZeneca Vaxzevria/COVISHIELD COVID-19 vaccine, and the vaccine name of five were unspecified.
Among the 540 reports of myocarditis/pericarditis following Pfizer-BioNTech Comirnaty COVID-19 vaccine(administered to those 12 years of age and older):
- Symptoms started between 5 minutes and 94 days after vaccination
- Median age is 27 years (age range 12 to 87 years old)
- 338 were males [median age 21 years (age range 12 to 84 years old)], 194 were females [median age 39 years (age range 12 to 87 years old)], the sex of one was ‘other’, and the sex of seven were unspecified
- 220 reports following the first vaccine dose, 245 reports following the second vaccine dose, and the dose number for 74 were not specified
- Current analyses show the number of reports of myocarditis/pericarditis following the Pfizer-BioNTech Comirnaty COVID-19 vaccine is higher than what would be expected in the general population of males and females less than 30 years old and primarily following the second dose.
Among the 348 reports of myocarditis following vaccination with a Moderna Spikevax COVID-19 vaccine(administered to those 12 years of age and older)
- Symptoms started between 14 minutes and 69 days after vaccination
- Median age is 28 years (age range 17 to 95 years old)
- 253 were males [median age 26 years (age range 17 to 95 years old)], 90 were females [median age 34 years (age range 18 to 76)], the sex of one was ‘other’, and the sex of four were unspecified
- 72 reports following the first vaccine dose, 234 reports following the second vaccine dose, and the dose number for 40 were unspecified
- Current analyses show the number of reports of myocarditis/pericarditis following the Moderna Spikevax COVID-19 vaccine is higher than what would be expected in the general population, particularly among males and females less than 40 years old and following the second dose.
You can find all of these stats here: https://health-infobase.canada.ca/covid-19/vaccine-safety/#detailedSafetySignals
Gagnon says “Safety and effectiveness of the vaccine in adolescents will continue to be monitored in clinical trial participants and those receiving the vaccine through public health programs for a period of up to 2 years. NACI will closely monitor evolving evidence and update its recommendations, if needed. Health Canada will take action should any new safety signal be identified.”
According to Health Canada the risk of cardiac complications including myocarditis has been shown to be increased following COVID-19 infection, and that it is higher following infection than after vaccination in some age groups.
Sweden, Finland and Denmark paused the use of Moderna’s COVID-19 vaccine for younger age groups after reports of possible myocarditis. Canada now recommends younger age groups take the Pfizer vaccine instead of Moderna despite both having been linked hundreds of cases of myocarditis.
Health Canada says it continues to monitor all safety and effectiveness data from the real- world use of the vaccine since its deployment in Canada and internationally, including data in the younger age group where it is authorized for use, and will take action, if required.
Studies with the Comirnaty vaccine are ongoing in children less than 5 years of age, and other manufacturers are also testing their vaccines in children of various age ranges. Health Canada expects to receive data for review in the coming months.
This article has been updated with information on heart complications following a COVID-19 infection.