Question Period Note: VACCINES FOR CHILREN

• The Government of Canada prioritizes the safety, efficacy, and quality of vaccines, including vaccinations for children.
• On November 19th, the use of the Pfizer-BioNTech Comirnaty® in children aged 5 to 11 was approved. A submission from Moderna for its Spikevax® vaccines for younger age groups is also being reviewed. Both Pfizer and Moderna have been approved for use in children 12 years and older.
• Studies with the Comirnaty vaccine are ongoing in children under 5 years of age, and other manufacturers are also testing their vaccines in children of various age ranges. Data is expected to be received in the coming months for review.
• A lower dose than used in adults is anticipated to be sufficient for vaccine effectiveness in children aged 6 months to less than 12 years.
• The Government of Canada will continuously monitor the safety of the vaccines after approval in Canada and internationally, and take immediate action should any safety concern arise.

The risk of severe illness due to COVID-19 might be lower in children than in adults but this does not mean that there is no risk:

• Children can still contract COVID-19 and get very sick.
• In Canada, more than 1000 children (ages 0-19) have been hospitalized with COVID-19, 164 have been admitted to the ICU and 14 have died.
• In Canada, there have been 120,497 COVID cases in children aged 5-11 years. Of these cases 291 were hospitalized, of which 46 were admitted to ICU, and 2 cases resulted in death (as of November 2021).
• Some children go on to develop a Multi Inflammatory Syndrome and become severely affected. Although rare, this is not an insignificant risk.
• Emerging data suggest that children that survive COVID-19 despite of the severity, are at risk of developing what is now called “long COVID”. This condition is yet poorly understood but it has been observed in a percentage of adults and children that survive COVID-19.
• In addition, children, like adults, can still spread the virus to others. In order to best protect themselves and the whole community, adolescents and children who are eligible should be vaccinated if there are no contraindications.

PFIZER Pediatric COVID-19 Vaccine Comirnaty
On May 5, 2021 Health Canada approved the use of the Pfizer-BioNTech Comirnaty®vaccine in children aged 12-15.

This information was also submitted to the US FDA and the European Medicines Agency. The expanded indication was approved by the US FDA on May 10, 2021 and by the EMA on May 28, 2021.

Pfizer has completed their clinical trials involving up to 4,600 children ages 6 months to 11 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. The trials evaluated the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart).

On October 26, 2021, the US FDA’s Vaccines and Related Biological Products Advisory Committee voted to agree that the overall benefits of the vaccine outweigh the risks for children 5-11 years of age. Many committee members stressed that this was based on considerations of access and personal choice and should not be considered a recommendation to mandate vaccines in this age group Active safety monitoring for rare, but potentially serious, adverse events such as myocarditis will be important.

On November 19, Pfizer's pediatric vaccine (aged 5 to 11) was approved by Health Canada and the National Advisory Committee on Immunization (NACI) released their guidelines.

On October 29, 2021 the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.

On November 5, 2021, the US CDC’s Advisory Committee on Immunization Practices (ACIP) issued an Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years.

In the United States, as of November 17 more than 1.7 million children between the ages of 5 and 11 have received their first dose of Pfizer’s vaccine, and no safety issues have been identified. The safety profile of children 5 to 11 is generally comparable to what was observed for the 12 to 15 year olds.

MODERNA Pediatric COVID-19 Vaccine Spikevax
On August 27, 2021, Health Canada approved the use of The Moderna COVID-19 Vaccine in children aged 12 to 17.

On November 16th, Moderna filed their pediatric dossier for ages 6 months to 11 years and Health Canada will continue to prioritize the pediatric submissions once they are filed.

Other Vaccines
Clinical trials for the Janssen and AstraZeneca vaccines in children were paused in Spring 2021 due to concerns with blood clots reported with use of the vaccines in adults. The Janssen trial has since restarted, with plans to continue recruitment of younger pediatric patients.

Other manufacturers such as Novavax have also launched clinical trials to test their vaccine in adolescents.

None