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

• Vaccine use in children under 12 years of age.

• On November 19, 2021, Health Canada approved the use of Pfizer-BioNTech Comirnaty® in children aged 5 to 11.
• On March 17, 2022, Health Canada approved the use of Moderna’s Spikevax® vaccine in children aged 6 to 11.
• On April 29, 2022, Health Canada received a submission from Moderna for a COVID-19
vaccine in children 6 months to 5 years of age. The vaccine submission is under review.
• On May 27, 2022, Health Canada received a submission from Pfizer for a COVID-19 booster for children aged 5 to 11. The vaccine submission is being reviewed on a priority basis.
• 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 and Spikevax to support the authorization of the vaccine in adults, adolescents and children.
• The risks and benefits are evaluated for each age group in the context of COVID disease. This requires consideration of vaccine side effects and benefits.
• 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. This resulted in the identification of a lower dose for children, while still maintaining effectiveness.
• The Department continuously monitors the safety of the vaccines after approval in Canada and internationally, and takes immediate action should any safety concerns arise.

IF PRESSED ON AVAILABILITY OF OTHER VACCINES
• On April 29, 2022, Health Canada received a submission from Moderna for a COVID-19
vaccine in children 6 months to 5 years of age. The vaccine submission is under review.
• A study with the Comirnaty vaccine is underway in children under 5 and other manufacturers are also testing their vaccines in children of different age groups. Health Canada expects to receive data for review in the coming weeks.

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 4,000 children (ages 0-19) have been hospitalized with COVID-19, 422 have been admitted to the ICU and 33 have died (as of February 25, 2022.
• In Canada, there have been 355,737 COVID cases in children aged 0-11 years (as of February 25, 2022).
• 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 Adolescent and Pediatric COVID-19 Vaccine Comirnaty
• On May 27, 2022, Health Canada received a submission from Pfizer for a COVID-19 booster for children aged 5 to 11. The vaccine submission is under review.
• On May 5, 2021 Health Canada approved the use of the Pfizer-BioNTech Comirnaty®vaccine in adolescents aged 12-15.This information was also submitted to the US FDA and the European Medicines Agency. The expanded indication for 12-15 years old 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 5 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 November 19, 2021, Pfizer's pediatric vaccine (ages 5 to 11) was approved by Health Canada and the National Advisory Committee on Immunization (NACI) released their guidelines also recommending the use in this age group.
• 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 October 29, 2021 the U.S. FDA 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 March 2, 2022 more than 9 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 Adolescent and Pediatric COVID-19 Vaccine Spikevax
• On August 27, 2021, Health Canada approved the use of the Moderna COVID-19 Vaccine in adolescents aged 12 to 17.
• On March 17, 2022, Health Canada approved the use of the vaccine in ages 6 to 11 years. The Moderna pediatric dose is half (50 micrograms) of the dose given to adolescents and adults.
• On April 29, 2022, Health Canada received a submission from Moderna for a COVID-19 vaccine in children 6 months to 5 years of age. The vaccine submission is under review.
• Health Canada reviewed clinical trial results from a placebo-controlled study designed to evaluate the safety and efficacy of the vaccine in children 6 to 11 years of age. In total, 4,016 children 6 to 11 years of age were enrolled; 3,012 children received Spikevax and 1,004 children received a placebo.
• The study used a two-dose vaccine regimen with the same formulation as the adult vaccine. However, the dose used was smaller, at 50 micrograms rather than 100 micrograms.
• The clinical trial of Spikevax (50 mcg) in children 6 to 11 years of age studied the immune response to vaccination based on antibody levels. The trial showed that the vaccine produced similar levels of antibodies in children 6 to 11 years of age compared to adolescents and young adults.
• Provisionally approved in Australia for individuals 6 years and older. EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6 to 11.

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 the use of these vaccines in adults. The Janssen & AstraZeneca trials have restarted; Janssen has plans to continue recruitment of younger pediatric patients.
• Other manufacturers such as Novavax have also launched clinical trials to test their vaccine in adolescents.

Boosters for Adolescents
• On June 1st, 2022, Health Canada authorized Pfizer Comirnaty booster dose vaccine in adolescents 16-17 years of age.
• On March 16, 2022, Health Canada received a submission from Moderna for a COVID-19 booster for individuals 12 to 17 years of age. On January 28, 2022, the Public Health Agency of Canada (PHAC) released guidance from the National Advisory Committee on Immunization (NACI) on the off-label use of booster COVID-19 vaccine doses in adolescents 12 to 17 years of age who are at high risk of severe COVID-19 outcomes due underlying medical conditions or living conditions, or who belong to racialized or marginalized communities disproportionately affected by COVID-19.

KEY FACTS
• Pfizer-BioNTech Comirnaty is authorised in younger children, ages 5-11. Moderna SpikeVax is also authorised in younger children, ages 6-11.
• 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.
• The positive results in Moderna’s clinical trials involve approximately 4,000 children ages 6 to 11 years of age. The trial showed that the vaccine produced similar levels of antibodies in children 6 to 11 years of age compared to adolescents and young adults.