Summary of NACI statement of June 9, 2023: Interim guidance on the use of bivalent Omicron-containing COVID-19 vaccines for primary series

On this page

• Overview
• What you need to know
• Quotes

Overview

• On June 9, 2023, the Public Health Agency of Canada released interim guidance from the National Advisory Committee on Immunization (NACI) on the use of bivalent Omicron-containing COVID-19 vaccines for the primary series. This guidance is based on current evidence, vaccine principles and NACI expert opinion.
• NACI now recommends that:
  • When mRNA COVID-19 vaccines are used for the primary series, bivalent Omicron-containing vaccines can be used in individuals 6 months of age and over.
• For more information on recommended vaccine products and dosages per age group, please see NACI Statement: Interim guidance on the use of bivalent Omicron-containing COVID-19 vaccines for primary series.
• Individuals who have not received previously recommended doses, including a primary series or fall 2022 booster dose, are recommended to receive them now. For more information, please refer to Guidance on COVID-19 vaccine booster doses: Initial considerations for 2023.

What you need to know

• In the coming months, most original monovalent (non-Omicron containing) mRNA COVID-19 vaccines will no longer be available in Canada. As such, the Public Health Agency of Canada asked NACI to consider the off-label use of bivalent Omicron-containing mRNA COVID-19 vaccines for the primary series.
• Bivalent Omicron-containing mRNA COVID-19 vaccines are currently only authorized for use as booster doses for people 5 years of age and older. They have been the preferred vaccine products for boosters since October 2022.
• NACI considered the available evidence on bivalent Omicron-containing mRNA COVID-19 vaccines used for a primary series and accumulating real-world evidence on effectiveness and safety of bivalent Omicron-containing mRNA COVID-19 vaccine booster doses.
• Health Canada is currently reviewing manufacturer submissions for the use of bivalent Omicron-containing mRNA COVID-19 vaccines for the primary series.
• NACI has made interim off-label recommendations considering the currently available bivalent Omicron-containing mRNA COVID-19 vaccines. As regulatory submissions are submitted and reviewed by Heath Canada in the coming months, vaccine schedules and/or dosages may change for some age groups.
• NACI continues to closely monitor COVID-19 activity across Canada and emerging evidence on COVID-19 vaccines and will update recommendations as needed.

For the full statement, including supporting evidence and rationale, please see NACI Statement: Interim guidance on the use of bivalent Omicron-containing COVID-19 vaccines for primary series.

For more information on NACI's recommendations on the use of COVID-19 vaccines, please refer to the COVID-19 vaccine chapter in the Canadian Immunization Guide (CIG), as well as additional statements on the NACI web page.

Quotes

"Canada has seen success with bivalent COVID-19 vaccines when they have been used for booster doses. NACI is now recommending to also move towards bivalent COVID-19 vaccines for the primary series in anyone who has not yet received their first doses of COVID-19 vaccines. Over the summer we may see more changes in the COVID-19 vaccine products available for Canadians as the science and technologies evolve to provide the best protection."

"I welcome NACI's interim recommendation on the use of bivalent COVID-19 vaccines for people who have not yet been vaccinated against SARS-CoV-2. This recommendation reflects growing real-world evidence on the effectiveness and safety of bivalent vaccines, while underscoring the continued importance of receiving an initial series of COVID-19 vaccines. SARS-CoV-2 is still circulating throughout Canada and globally, and vaccination remains one of the best ways to protect oneself from severe COVID-19 outcomes."