Question Period Note: Update on mRNA vaccine supply

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• What is the Public Health Agency of Canada doing to ensure there is sufficient mRNA vaccine supply to complete current booster and pediatric campaigns for Canadians and to respond to COVID-19 variants of concern?
• Canada continues to meet the needs of Canadians with ample vaccine supply in 2022 and beyond.
• In 2020, Canada established advance purchase agreements with manufacturers to ensure access to the best possible vaccine supply. This strategy has served Canada well in terms of access to significant supply of Pfizer and Moderna mRNA vaccine.
• With the combination of vaccines already on-soil and upcoming deliveries, Canada has sufficient supply to ensure all eligible Canadians seeking COVID-19 vaccination are protected for primary series, applicable boosters, and pediatrics including infant vaccines.
• Canada’s contracts with Pfizer and Moderna provide for sufficient mRNA doses to meet all potential domestic needs until the end of 2023, including extra options in both 2022 and 2023, and an optional year in 2024.
• In 2022 alone, up to 100 million doses of mRNA vaccine could be available to Canadians.
• We have built flexibility into these agreements to ensure that we have access to new products and formulations, which positions us well to act quickly to implement boosters and respond with variant-specific formulations following regulatory approval.
• Novavax is the first protein subunit vaccine available in Canada, and an initial shipment was delivered in March 2022. Canada also expects additional non-mRNA vaccines to become available providing millions of additional doses.

If pressed on the growing demand for vaccines in the face of variants of concerns like Omicron
• With the combination of doses already on-soil and upcoming deliveries, Canada has sufficient supply to ensure Canadians seeking vaccination are protected for primary series, boosters, and pediatrics including infant vaccines.
• In the face of Omicron, Canada was able to on-board sufficient supply of both pediatrics and boosters for the provinces and territories to expedite simultaneous vaccine campaigns.
• The Public Health Agency of Canada and Health Canada continue to work closely with provinces and territories and Indigenous partners to ensure effective COVID-19 responses, including vaccine rollout.

If pressed on access to variant specific formulations of vaccines
• The Public Health Agency of Canada (PHAC) continues to make sure that Canada is prepared to manage COVID-19 and its possible evolutions.
• Current agreements already provide access to new formulations, including variant specific formulations that may be developed by vaccine manufacturers in the future.
• On September 1, 2022, Health Canada approved Moderna’s BA.1 bivalent booster for people aged 18 years and older, and is reviewing the BA.1 bivalent booster for people aged 12 years and older submitted by Pfizer-BioNTech. Also, Health Canada is currently reviewing the rolling submission from Pfizer-BioNTech and Moderna for their bivalent BA.4/.5-targeting products.
• Health Canada issued new guidance on modifying existing vaccines to respond to variants. Health Canada reviews all vaccine applications through an independent process and authorizes products based on scientific rigor and medical evidence.
• Vaccination is and will continue to be a critical public health measure and the existing formulations continue to be effective for the prevention of severe outcomes of COVID-19.

If pressed on pediatric vaccine supply
• The Government of Canada and Pfizer agreed to accelerate the delivery of 5.8 million doses of pediatric vaccine in December 2021 and January 2022 to provide first and second doses to all eligible children in Canada aged 5 to 11 years old.
• Additionally, in March 2022, Health Canada authorized Moderna’s vaccine for use in children aged 6 to 11 years old.
• All provinces and territories have now received their shipments and begun administering the vaccines to children.
• Current contracts will have ensured access to pediatric vaccines for the youngest eligible age group (6 months – 4 years).
• On July 14, 2022, Health Canada authorized Moderna’s vaccine for use in children 6 months to 5 years of age. More than 700,000 doses have been made available to provinces and territories to support their vaccination efforts in this age group.
• On September 9, 2022, Health Canada authorized the Pfizer-BioNTech vaccine for use in children 6 months to 4 years of age. Shipments to Canada and distribution to provinces and territories are expected to begin shortly.

If pressed on supply to provide booster doses to all eligible Canadians
• Canada has sufficient mRNA doses on soil for all eligible Canadians seeking a booster dose.
• Canada’s contracts with Pfizer and Moderna ensure that there is sufficient supply for Canadians seeking a booster dose in 2022.

If pressed on booster supply for the 5-17 age group
• On August 19, Health Canada approved Pfizer-BioNTech's COVID-19 vaccine as a booster dose for children aged five to 11.
• Canada’s contracts provide sufficient doses of mRNA to provide boosters per National Advisory Committee on Immunization (NACI) guidance for Canadians aged 5 to 17 seeking vaccination in 2022.

If pressed on supply of non-mRNA vaccine
• The Government of Canada has worked with provinces and territories and manufacturers to ensure non-mRNA options are available for those who cannot or will not take an mRNA vaccine.
• Novavax is the first protein subunit vaccine available in Canada, and an initial shipment of 3.2 million doses was delivered in March 2022.
• Canada currently has over 150,000 doses of Janssen in storage.

If pressed on Medicago APA
• The Government of Canada continues to work with Medicago on its COVID-19 vaccine commitments. An initial shipment date is not available at this time.

If pressed on vaccine donations
• Canada is on track to meet the commitment to donate the equivalent of 200 million doses by year end.
• This includes both financial commitments to COVAX and surplus dose donations.
• As of September 13, 2022, Canada has donated the equivalent of more than 140 million doses; comprised of more than 3.76 million vaccine doses through direct, bilateral agreements with recipient countries, the equivalent of 87 million doses in financial contributions to the vaccines pillar of the ACT Accelerator, plus 50 million doses deemed surplus from Canada's domestic supply. Of those 50 million, COVAX has delivered 21.7 million to low- and middle-income countries.
• Canada is continuing to allocate donations primarily through the COVAX Facility on an ad hoc basis according to country demand.

If pressed on vaccine expiring and disposal
• From the outset, the Government of Canada's procurement approach has been focused on building a diverse vaccine supply and securing access to safe and effective COVID-19 vaccines now and into the future. To maximize the use of Canada’s vaccine supply, we:
o coordinate transfers of doses between provinces and territories to move vaccines to where they are needed most
o work with manufacturers to ensure there are sufficient doses available to meet demand
o monitor for the possibility of shelf-life extensions
o offer vaccines in surplus of our domestic needs with a sufficient shelf life to support campaigns for global donations
• This approach ensures that we have enough vaccine supply for people in Canada to stay up to date on their vaccines, including boosters. Canada continues to work closely with COVAX and other key stakeholders, including manufacturers, to ensure that surplus Canadian doses are made available for donation with the longest shelf life possible.
• At this time, global production and dose donations from high-income countries are exceeding administration capacity and demand of low- and middle-income countries. Given the current global imbalance in supply and demand, many countries are experiencing similar difficulties in donating excess supply, and some wastage is inevitable.
• Vaccines are a biological product, therefore have limited shelf life for use. Despite efforts of supply management and good stewardship of goods, there will be wastage as doses expire before they’re used in Canada or eligible for donation, and must be disposed of in accordance with appropriate handling and storage guidelines.
• Disposal of pharmaceuticals including vaccines that have reached expiry with no possibility of shelf life extension is a component of good pharmaceutical management, which helps ensure that people in Canada have access to stable and effective products.
• The existing vaccine formulations continue to be effective for the prevention of severe outcomes of COVID-19 and are the only ones currently approved for primary series in Canada. Canada will continue to manage the existing inventory of COVID-19 vaccines and will not dispose of any vaccine doses prior to the end of their shelf life.

If pressed on Canadian manufacturing supply
• While our agreements have provided access to an abundance of supply, Canada has also developed a Biomanufacturing and Life Science Strategy to address, in part, the security of future vaccine supply.
• An MOU between the Canadian Government and Moderna has already been signed to begin domestic production of mRNA vaccines in order to combat respiratory viruses, including COVID-19 and seasonal influenza.

Canada has publicly announced the following agreements:
- Pfizer firm (option)
o 2022 : 35M (30M option)
o 2023 : 30M (30M option)
o 2024 : (60M option)
- Moderna firm (option)
o 2022 : 20M (15M option)
o 2023 : 20M (15M option)
o 2024 (35M option)
- Total firm mRNA (options)
o 2022 : 55M (45M option)
o 2023 : 50M (45M option)
o 2024 : (95M option)
- Novavax firm and options
o Up to 76M
- Medicago firm and options
o Up to 76M

• The agreements provide flexibility to procure next-generation COVID-19 vaccine adaptations, such as those to protect against mutations or variants of concern, and vaccines developed for younger populations.
• Sanofi’s APA (if a vaccine is approved) is also expected to provide millions of additional non-mRNA doses.

• Canada’s vaccine acquisition strategy continues to evolve based on demand, new product development and scientific guidance and will provide robust and flexible supply to meet a variety of potential needs over the coming years.
• Canada has sufficient supply of mRNA to meet the demand for 2022.
• Canada has agreements with Moderna and Pfizer for a combined supply of up to 100 million mRNA doses for 2022 (55 million firm doses, plus 45 million doses in options) and up to 95 million mRNA doses in 2023 (50 million firm doses, plus 45 million doses in options) with options to extend into 2024.
• In addition to providing booster vaccine doses, the agreements provide flexibility to procure new next-generation COVID-19 vaccine formulations, such as those to protect against variants of concern, and those developed for younger populations, if they become available.