Question Period Note: Access to vaccines for COVID-19

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• Six COVID-19 vaccines are currently authorized by Health Canada and others are under review.
• 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, Janssen, Novavax and Medicago.
• In addition, there are two other vaccines currently under review by Health Canada from Sanofi and Vaccigen (Covaxin).
• On September 9, 2022, Health Canada authorized the Pfizer-BioNTech Comirnaty COVID-19 vaccine for young children aged 6 months to under 5 years of age.
• On September 1, 2022, Health Canada authorized the first bivalent COVID-19 vaccine for use in Canada. Moderna Spikevax bivalent vaccine targets the original SARS-CoV-2 virus from 2019 and the Omicron (BA.1) variant, and is authorized for use as a booster dose in individuals 18 years of age or older.
• Submissions from Pfizer-BioNTech for a BA.1 bivalent vaccine and a BA.4/5 bivalent vaccine have been received and are under review. A submission from Moderna for a bivalent BA.4/5 vaccine has also been received and is under review.
• A submission from Moderna for a booster dose for individuals 12 to 17 years of age is also under review.
• 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 manufacturers 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 vaccines. 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 MEDICAGO …
• Our Government recognizes the need for a strong and resilient domestic bio-manufacturing industry, and that is why we have made a significant investment in Medicago.
• This is the first authorized COVID-19 vaccine developed by a Canadian-based company, and the first that uses a plant-based technology.
• Health Canada is prepared to work closely with regulatory authorities in other countries or regions to share information on the Department’s review of Medicago’s Covifenz and support authorization in other countries, as well as enable other countries’ access to Covifenz vaccine supplies that may become available in the coming months.
• In July 2022, Medicago notified HC that they were investigating a manufacturing quality issue that prevented them from distributing Covifenz as planned. The length of time before commercial production can restart is unknown.
• Canada has studied the matter of the Government of Canada’s investment in Medicago carefully and considers that it is compliant with its treaty obligations related to tobacco control under the WHO Framework Convention on Tobacco.
• Health Canada takes its commitments under the Framework Convention on Tobacco Control seriously, and will continue to be transparent in its interactions with the tobacco industry.

IF PRESSED ON OMICRON …
• On September 1, 2022, Health Canada authorized Moderna Spikevax bivalent Original/Omicron BA.1 COVID-19 booster vaccine in adults 18 years of age and older.
• Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that targets the original strain of SARS-CoV2 and the Omicron variant of concern (BA.1). This is the first vaccine authorized in Canada containing both the original Wuhan SARS-CoV-2 and the Omicron variant.
• On July 25, 2022, Health Canada received a submission from Pfizer-BioNTech for the Comirnaty Bivalent Original/Omicron (BA.1) COVID-19 booster vaccine in adults. The submission in under review; and on September 2, 2022, Health Canada received a submission from Pfizer-BioNTech for the bivalent Original and BA.4/BA.5 COVID 19 booster vaccine.
• On September 12, 2022, Health Canada received a submission from Moderna for the Spikevax Bivalent Original and BA.4/BA.5 COVID-19 booster vaccine.
• Health Canada issued regulatory letters to manufacturers of authorized COVID-19 vaccines and to those under review, requesting plans to evaluate and address the impact of the omicron variant on their product and include any proposed studies, timelines for completion and risk minimization measures. Canadians will be informed in a timely manner of any new key information about the impact of omicron on vaccine effectiveness.
• Health Canada is working with manufacturers and international regulatory partners, including WHO, to assess the potential impact of the omicron variant on approved, 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 or any other 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, hospitalization 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.
• Health Canada authorized the booster dose of the Pfizer Comirnaty vaccine for adolescents 16-17 years of age on June 1, 2022 and for children 5 to 11 years of age on August 19, 2022.
• On March 16, 2022, Health Canada received a submission from Moderna for a COVID-19 booster for individuals 12 to 17 years of age.

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 submissions in terms of subsequent data and information to Health Canada to support the rolling reviews.
• 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.
• 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.

IF PRESSED ON INTERIM ORDER/AMENDED REGULATIONS …
• Health Canada put in place 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, Moderna, Novavax and Medicago have been authorized under the new Regulations.
• Vaccines not yet authorized for sale in Canada, such as those from Sanofi and Vaccigen, are also being reviewed under the new Regulations.

Summary of approved vaccines, status of ongoing reviews and international comparisons

Original vaccine approvals
Health Canada authorized the Pfizer-BioNTech Comirnaty® vaccine under the Interim Order on December 9, 2020, and authorized it under the Regulations on September 16, 2021.

Health Canada authorized the Moderna Spikevax® vaccine under the Interim Order on December 23, 2020, and authorized it under the Regulations on September 16, 2021.

Health Canada authorized the AstraZeneca Vaxzevria vaccine under the Interim Order on February 26, 2021, and authorized it under the Regulations on November 19, 2021. Health Canada worked closely with the European Medicines Agency on the initial review.
Health Canada authorized the Janssen Jcovden vaccine on March 5, 2021 under the Interim Order, and authorized it under the Regulations on November 23, 2021.

Health Canada authorized the Novavax Nuvaxovid COVID-19 vaccine on February 17, 2022 under the Regulations. Health Canada authorized the Medicago Covifenz COVID-19 vaccine on February 24, 2022 under the Regulations. This is the first authorized COVID-19 vaccine developed by a Canadian-based company, and the first that uses a plant-based technology.

Pediatric and Adolescent approvals
• Health Canada authorized the use of the Pfizer vaccine in children aged 5-11 years on November 19, 2021, in children aged 12-15 years on May 5, 2021 and in younger children 6 months to under 5 years of age on September 9, 2022.
• The Moderna vaccine was authorized for use in individuals aged 12-17 years on August 27, 2021, in children aged 6-11 years on March 17, 2022 and in younger children aged 6 months – 5 years on July 14, 2022.

(Please see separate QP on COVID-19 vaccines for children).

Boosters
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 and on May 11, 2022, Health Canada authorized the Janssen (Jcovden) booster dose.

On June 1, 2022, Health Canada authorized the booster dose of the Pfizer Comirnaty vaccine for adolescents aged 16-17 years and for children aged 5-11 years on August 19, 2022. On March 16, Health Canada received a submission from Moderna for a COVID-19 booster for individuals 12 to 17 years of age.

On September 1, 2022, Health Canada authorized the first bivalent COVID-19 vaccine for use in Canada. Moderna Spikevax bivalent vaccine targets the original SARS-CoV-2 virus from 2019 and the Omicron (BA.1) variant, and is authorized for use as a booster dose in individuals 18 years of age or older.

Submissions from Pfizer-BioNTech for their BA.1 bivalent and BA.4/5 bivalent vaccines are under review. A submission from Moderna was received on September 12, 2022 for their BA.4/5 bivalent vaccine and is under review.

Ongoing reviews of other vaccines
Vaccine submissions from Sanofi and Vaccigen (vaccine 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.

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®, Moderna Spikevax®, AstraZeneca Vaxzevria®, Janssen Jcovden, Novavax Nuvaxovid and Medicago Covifenz vaccines were authorized under the modified Regulations

Medicago
On February 24, 2022, after a rigorous and independent scientific review of the evidence, Health Canada authorized the use of Medicago’s Covifenz COVID-19 vaccine.

Medicago is the first authorized COVID-19 vaccine developed by a Canadian-based company, and the first that uses a plant-based protein technology to prevent COVID-19 infection.

Health Canada is prepared to work closely with regulatory authorities in other countries or regions to share information on the Department’s review of Covifenz and support authorization in other countries, as well as enable other countries’ access to Covifenz vaccine supplies that may become available in the coming months.

The Government of Canada has studied the matter of its investment in Medicago carefully and considers that it is compliant with its treaty obligations related to tobacco control under the WHO Framework Convention on Tobacco (FCTC). The FCTC requires Parties to the Convention to specifically protect “public health policies with respect to tobacco control” from “commercial and other vested interests of the tobacco industry.” As such, the FCTC does not preclude the Government of Canada from working with Medicago on vaccine development and procurement to ensure that a ready and effective supply of vaccines is available for its population.

Article 5.3 of the Framework Convention on Tobacco Control requires Parties to the Convention to specifically protect “public health policies with respect to tobacco control” from “commercial and other vested interests of the tobacco industry.”

Health Canada’s interactions with the tobacco industry will continue to be transparent in accordance with Health Canada’s openness and transparency requirements and in alignment with guidelines under the WHO Framework Convention on Tobacco Control.

• 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.