Question Period Note: ACCESS TO VACCINES FOR COVID-19

• What is the current status of COVID-19 vaccines expected to be available for Canadians?

KEY MESSAGES
• With five vaccines now authorized - Pfizer, Moderna, AstraZeneca vaccines, and Janssen - we have additional tools to fight this pandemic as quickly as possible.
• Health Canada has also approved the use of the Pfizer vaccine in children aged 12-15, and has begun to review data for use of the Moderna vaccine in children aged 12-17.
• In addition, there are two other vaccines currently under review by Health Canada, from Novavax and Medicago.
• Health Canada is using agile regulatory processes to review vaccines as quickly as possible, 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.
• All vaccines in use in Canada are closely monitored through Canada’s vaccine safety monitoring system.

IF PRESSED ON DIFFERENCES BETWEEN THE AUTHORIZED VACCINES
• The Janssen vaccine is the first single-dose COVID-19 vaccine to be authorized in Canada. All other authorized vaccines require two doses. As with the AstraZeneca vaccine, the Janssen vaccine can also be stored and transported at refrigerated temperatures, between 2 and 8˚C for at least three months, giving greater flexibility in how it can be distributed across Canada.
• With the exception of the Pfizer vaccine, which is authorized for people 12 years of age and older, the authorized vaccines are currently only for use in adults (18 years and older).
• The authorization of additional vaccines to fight this pandemic can only help. They provide additional tools to fight COVID-19 as quickly as possible, and will provide more supply to the market.

IF PRESSED ON EFFICACY OF JANSSEN AND ASTRAZENECA COMPARED TO HIGHER EFFICACY OF MRNA VACCINES
• Each vaccine has unique characteristics and all authorized vaccines are helpful in the fight against COVID-19.
• Canada has negotiated a broad and diverse COVID-19 vaccine portfolio to ensure we have sufficient supply for everyone in Canada, while also mitigating risks of supply disruptions.
• Having additional vaccines from different manufacturers can help meet volume requirements to get more people vaccinated sooner and offers more vaccination options.

IF PRESSED ON ACCESS TO VACCINES FOR CHILDREN

• On May 5, 2021 Health Canada approved the use of the Pfizer vaccine in children aged 12-15.
• This information was also been 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.
• On June 4, Health Canada received a submission for use of the Moderna vaccine in children aged 12-17.

• Pfizer has an ongoing study in children aged 6 months -12 years.
• Moderna also has ongoing pediatric studies.
• Manufacturers of other authorized vaccines have pediatric studies planned, but these have not yet started or are currently on hold.

IF PRESSED ON THE TIMING OF APPROVALS IN GENERAL
• The vaccines are being reviewed as rolling submissions under the Interim Order signed by the Minister of Health in September, which allows companies to submit evidence on safety, effectiveness and quality to Health Canada as it becomes available.
• Each manufacturer files a detailed plan that lays out the timing and content of the subsequent data and information submissions to Health Canada to support the rolling reviews.
• Timing for the completion of the rolling submission depends on the outcomes of the companies’ ongoing clinical trials, as well as the finalization of their manufacturing sites and processes for Canadian supply.
• As the manufacture of vaccines is being scaled up globally, the sites making vaccines for Canada may be different from sites making vaccines for Europe or the US. These differences may result in different timelines for authorization.
• Health Canada has also hired additional scientists and has established dedicated review teams for COVID-19 vaccines, in order to ensure consistency in their review. These teams have been working around the clock to expedite reviews.

IF PRESSED ON TIMING OF OTHER DECISIONS
• Health Canada continues to review the Novavax and Medicago vaccines. We aim to issue a decision in general alignment with those of our major regulatory partners.

BACKGROUND
Expediting processes to make vaccines available

Since the start of the pandemic, Health Canada has worked closely with other departments and the Vaccine Task Force to develop and implement Canada's vaccine strategy.

In September, Health Canada issued an Interim Order to expedite the review of drugs and vaccines by allowing companies to submit safety and efficacy data as soon as it becomes available.
Health Canada only authorizes a vaccine if it is supported by very robust scientific data and evidence showing that the benefits of the vaccine clearly outweigh any potential risks.
Advance purchase agreements

The Government has announced agreements to secure millions of doses of seven leading vaccine candidates, including those being developed by AstraZeneca, Sanofi/GlaxoSmithKline, Johnson & Johnson, Novavax, Moderna, Pfizer, and Medicago.
The supply of any of these vaccines is dependent on successful completion of clinical trials and authorization by Health Canada.
Health Canada is actively working with the manufacturers of the vaccine candidates recommended by the Vaccines Task Force. While regulatory approvals are separate from the procurement process, Health Canada is expediting all vaccine drug submissions.
Status of ongoing reviews and international comparisons
Health Canada authorized the Pfizer vaccine on December 9, 2020, a week after the UK authorized it, two days before the US FDA, and almost two weeks before Europe.
Health Canada authorized the Moderna vaccine on December 23, 2020, 5 days after the US, and the Janssen vaccine 6 days after the US.
Health Canada, Europe, the UK, and other jurisdictions have now authorized the AstraZeneca vaccine. Health Canada worked closely with the European Medicines Agency on that review.
Health Canada continues to engage with all of the vaccine manufacturers to ensure that data is submitted to Canada at the same time it is provided to other major regulators, which is supporting similar completion timelines.
Health Canada authorized the use of the Pfizer vaccine in children aged 12-15 on May 5, 2021 ahead of the US and EMA.

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