Question Period Note: Booster Shots

• The availability of safe and effective COVID-19 vaccines and booster shots is of the utmost priority to the Government of Canada.
• The National Advisory Committee on Immunization (NACI) recommends booster shots for long-term care residents, seniors in other congregate living settings, high-risk populations, and those who are moderately to severely immunocompromised.
• In November 2021, the Government of Canada authorized the use of the Pfizer-BioNTech Comirnaty and Moderna Spikevax COVID-19 vaccines as booster shots.
• 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.

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 and aged 12-15 on May 5, 2021. Moderna vaccine was approved for children (12-17 years old) on August 27, 2021.

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 (Covaxin) 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.

None