Summary of National Advisory Committee on Immunization (NACI) statement: Recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5 to 11 years of age

Publication date: November 19, 2021

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Overview

NACI recommends that:

To see the full guidance, including the evidence and rationale behind these recommendations, please visit NACI recommendations on the use of the Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5 to 11 years of age.

What you need to know

NACI recommends:

To see the full guidance, including the evidence and rationale behind these recommendations, please visit NACI recommendations on the use of the Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5 to 11 years of age.

Quotes

“With the authorization of the Pfizer-BioNTech vaccine for children age 5 to 11 years, Canada is entering into a new phase of this pandemic vaccine program. Over the past two years, we have seen children face many social disruptions, as well as harms associated with pandemic restrictions, and though they are at lower risk of severe disease than adults, COVID-19 can result in serious outcomes in children, including hospitalization and in rare instances death. After carefully reviewing all of the clinical trial data for this new lower dose formulation of the Pfizer BioNTech COVID-19 vaccine for children, NACI is recommending that this COVID-19 vaccine may be offered to children aged 5 to 11 years as part of the immunization strategy in Canada. NACI is recommending at least 8 weeks between doses, as we have seen that this approach generates good sustained protection in adults and emerging Canadian data suggest that longer intervals could be associated with even lower rates of myocarditis in adults and adolescents. This vaccine had a good safety profile in clinical trials, and worked very well to prevent symptomatic disease in children.”

“We will be watching this new program very closely in Canada and abroad where it is already rolling out for children in the US, and new information will accumulate over time in greater numbers to complement the clinical trials data that have already been released. In this early phase of the vaccine program roll-out, it is essential that children and their caregivers are supported and respected in making their decisions regarding COVID-19 vaccination and are not stigmatized based on whichever choice they make. We hope that the availability of this vaccine will bring comfort to many families who have been working to protect their children throughout the pandemic.”

Dr. Shelley Deeks, NACI Chair

“I welcome this advice from NACI on the use of the pediatric dose formulation of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age. NACI’s review takes into account the available evidence on the use of the pediatric dose formulation as well as ethical considerations related to COVID-19 vaccination in children. To date, while most children who have been infected with the SARS-CoV-2 virus have had no symptoms or experienced only mild COVID-19 disease, some have experienced severe disease requiring hospitalization. Children can also develop a rare but serious condition called multisystem inflammatory syndrome (MIS-C), occurring several weeks following their infection. Other health impacts such as post-COVID syndrome (i.e., long COVID or post-acute COVID-19 syndrome), though less well understood, may also be a risk in this age group. As well, throughout the pandemic, children have experienced social isolation and disruption to schooling and extra-curricular activities, which have had impacts on their mental and physical well-being as well as that of their families. As such, it is hoped that the availability of this vaccine in Canada will provide families with an additional means to consider in protecting their children from the health and collateral harms of this pandemic. As we closely monitor the domestic rollout of the pediatric program and continue to consider new information from international programs and research, it is very important that we all support children and their caregivers in making informed decisions about COVID-19 vaccination, while respecting their choices and pace of decision-making.”

Dr. Theresa Tam, Chief Public Health Officer

NACI forward agenda

NACI continues to actively review emerging evidence on COVID-19 vaccines. Upcoming recommendation may include new advice on:

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