Question Period Note: ACCESS TO VACCINES FOR COVID-19

• Four COVID-19 vaccines are currently authorized by Health Canada and several others are under review.

KEY MESSAGES
• The availability of safe and effective COVID-19 vaccines is of the utmost priority. Health Canada has now authorized COVID-19 vaccines from Pfizer-BioNTech, Moderna, AstraZeneca and Janssen.
• In addition, there are four other vaccines currently under review by Health Canada from Novavax, Medicago, Sanofi and Vaccigen (Covaxin).
• On November 19, 2021, Health Canada authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine for children ages 5 to 11.
• In November 2021, Health Canada also authorized the use of a booster shot of the Pfizer-BioNTech Comirnaty and Moderna Spikevax COVID-19 vaccines. Public Health advice should be followed regarding who would benefit from a booster shot.
• 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.
• Health Canada will continue to review safety data submitted by the manufacturer and adverse event reports received in the Canada Vigilance Database. In addition, Health Canada will continue to work closely with the Public Health Agency of Canada, Provinces and Territories, and international regulators to monitor the safety of the vaccine. The Department will take appropriate action in a timely manner if new safety concerns are identified and will ensure that relevant information is available to all Canadians.
• All vaccines in use in Canada are closely monitored through Canada’s vaccine safety monitoring system.
IF PRESSED ON OMICRON
• Health Canada is working with manufacturers and international regulatory partners, including WHO, to assess the potential impact of the omicron variant on approved test kits, vaccines and treatments.
• As evidence emerges, Health Canada will take action and inform Canadians if there are changes to the safety or effectiveness of COVID-19 health products in Canada because of the omicron variant.
• If new vaccines or treatments are needed to address the omicron variant, Health Canada will prioritize the reviews to make these products available as soon as possible while maintaining high standards for safety, efficacy and quality.
IF PRESSED ON BOOSTER DOSE SUBMISSIONS
• People who have received a complete vaccine series, including older adults, have good protection against severe disease and death. This includes protection from variants of concern currently circulating in Canada. However, a third dose would ensure further protection.
• The National Advisory Committee on Immunization (NACI) strongly recommends that Canadians over the age of 50 and other vulnerable populations receive a third dose of an mRNA vaccine. Canadians aged 18 to 49 can also receive a third dose at least six months after they have received their second.
IF PRESSED ON THE TIMING OF APPROVALS FOR VACCINES UNDER REVIEW
• The vaccines are being reviewed as rolling submissions under the Food and Drug Regulations which allows companies to submit evidence on safety, effectiveness and quality to Health Canada as it becomes available. The Food and Drug Regulations were amended in March 2021 to provide the same flexibilities as under the Interim Order that was used for the initial authorizations.
• 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 submissions depends on the outcomes of the companies’ ongoing clinical trials and the review of the data submitted to Health Canada, as well as the finalization of their manufacturing sites and processes for Canadian supply.
• 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 INTERIM ORDER/AMENDED REGULATIONS
• Health Canada put in place temporary Interim Orders to facilitate expedited access to COVID-19 drugs and vaccines.
• Regulatory changes were made on March 18, 2021 to permanently transition measures from the Interim Order to the Food and Drug Regulations, to ensure that vaccines and drugs authorized under the Interim Order can continue to be sold and that new COVID-19 products can be reviewed and authorized using similar flexibilities.
• Companies that had a vaccine or drug authorized under the Interim Order were required to make a submission to Health Canada to receive authorization under the Food and Drug Regulations.
• To-date, the vaccines from Pfizer-BioNTech, AstraZeneca, Janssen and Moderna have been authorized under the new Regulations.
• Vaccines not yet authorized for sale in Canada, such as those from Novavax and Medicago, are also being reviewed under the new Regulations.

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 2020, 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 they become 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.

Since the Interim Order was temporary (valid for 1 year, expired on September 16, 2021), in March 2021 Health Canada introduced amendments to the Food and Drugs Regulations (Regulations) to provide a mechanism for COVID-19 products to gain permanent legal status and allow the vaccines to continue to be sold in Canada. Companies were required to file a submission to Health Canada under the amended Regulations. The Pfizer-BioNTech Comirnaty® and Moderna Spikevax® vaccines were first to be authorized under the Regulations on September 16, 2021. Their review was prioritized given that these are the two vaccines currently being used in Canada. AstraZeneca Vaxzevria® and Janssen were transitioned to the Regulations on the 19th and 23rd of November respectively

Status of ongoing reviews and international comparisons

Health Canada authorized the Pfizer-BioNTech Comirnaty® vaccine under the Interim Order on December 9, 2020.

Health Canada authorized the Moderna Spikevax® vaccine under the Interim Order on December 23, 2020.

Health Canada, Europe, the UK, and other jurisdictions have authorized the AstraZeneca Vaxzevria® vaccine. Health Canada worked closely with the European Medicines Agency on that review. Health Canada authorized the Janssen vaccine on March 5, 2021.

Health Canada authorized the use of the Pfizer vaccine in children aged 5-11 on November 19, 2021 and aged 12-15 on May 5, 2021. Moderna vaccine was approved for children (12-17 years old) on August 27, 2021. (Please see separate QP on COVID-19 vaccines for children).

On November 9, 2021, Health Canada authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot. On November 12, 2021, Health Canada authorized the use of the Moderna Spikevax vaccine as a booster shot.

Submissions from Novavax, Medicago, Sanofi and Vaccigen are under review. Timelines for decisions depend on the submission of outstanding data from the companies, discussions with the sponsors, and completion of Health Canada’s 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.

KEY FACTS

• 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.
• Health Canada only authorizes a vaccine if it is supported by scientific data and evidence showing that the benefits of the vaccine clearly outweigh any potential risks.