Question Period Note: ACCESS TO COVID-19 VACCINES FOR CHILDREN

• Vaccine use in children under 12 years of age.

KEY MESSAGES
• On November 19th, Health Canada approved the use of the Pfizer-BioNTech Comirnaty® in children aged 5 to 11.
• Health Canada is also reviewing a submission from Moderna for its Spikevax® vaccines for younger age groups.
• As with all COVID-19 submissions, the Department is prioritizing the review while maintaining our rigorous standards for safety, efficacy and quality.
• Health Canada is also working closely with other major regulators who are reviewing the same vaccines. These partnerships allow us to share scientific evidence and streamline review processes, while still making independent decisions for Canadians.
IF PRESSED ON HEALTH CANADA’S REVIEW PROCESS
• In order to expand the use of an authorized COVID-19 vaccine to younger children, the manufacturer must provide evidence of safety, efficacy and quality to Health Canada for review.
• Timing for the completion of a Health Canada review depends on many factors, including but not limited to, the need for additional data, discussions with the sponsor, and requirements for updates to safety information. A decision will only be made once all of the required information has been submitted by the manufacturer and thoroughly evaluated by Health Canada.
IF PRESSED ON SAFETY OF VACCINES IN CHILDREN
• The safety of vaccines for children is of the utmost priority for Health Canada. The Department will not compromise on the evidence standards for safety, efficacy and quality.
• The Department conducted a detailed review of the safety data from clinical trials of Comirnaty to support the initial authorization of the vaccine in adults, adolescents and children 5 years of age and older. The Department will similarly conduct a detailed review of the safety data available from Moderna to determine the vaccine’s safety in younger age group.
• The risks and benefits are evaluated for each pediatric population in the context of COVID disease. This requires consideration to vaccine side effects and benefits which are different for children than older adults and even adolescents.
• During clinical trials, dose-finding studies were conducted to determine the correct dose for vaccine effectiveness in children aged 6 months to less than 12 years. A lower dose than used in adults is anticipated to be sufficient for vaccine effectiveness in children.
• The Department will also continuously monitor the safety of the vaccines after approval in Canada and internationally, and take immediate action should any safety concern arise.
IF PRESSED ON AVAILABILITY OF OTHER VACCINES
• 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. Health Canada expects to receive data for review in the coming months.

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 1,000 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 to 11 years and Health Canada will continue to prioritize the pediatric submissions.

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.

KEY FACTS
• Pfizer-BioNTech Comirnaty is authorised in younger children, ages 5-11. Health Canada has also received a submission for the use of a COVID 19 vaccine in this younger age group from Moderna.
• The positive results in Pfizer’s clinical trials involves approximately 4,600 children ages 5 to 11 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. The 90.7% efficacy was established in 1,968 vaccine recipients, and vaccine safety was evaluated in 3,300 vaccine recipients.