mRNA vaccine boosters and procurement strategies for potential variant specific vaccines: Standing Committee on Health—January 18, 2022

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Procurement of COVID-19 vaccines

Context

Public Services and Procurement Canada (PSPC) is working with the Public Health Agency of Canada, Health Canada and Innovation, Science and Economic Development Canada (ISED), along with the COVID-19 Vaccine Task Force to procure COVID-19 vaccines, therapeutic drugs, and related supplies.

Vaccines

Suggested response

• Given intense global competition, Canada has taken an aggressive approach to secure access to one of the most diverse vaccine portfolios in the world
• Since July 2021, Canada has maintained a steady supply of doses for every eligible person who wants one. To date, Canada has received 103 million vaccine doses
• In light of the Omicron variant and recent developments on booster recommendations, Public Services and Procurement Canada continues to work with suppliers to ensure that there is a steady and sufficient supply of vaccines to administer to Canadians
• We are continuing to evolve our vaccine procurement strategy based on the best scientific advice available, which includes working with vaccine suppliers to secure new formulations for variants, boosters and pediatrics as they become available
• Canada has secured future supply with Moderna and Pfizer that will provide access to a range of products as required, including pediatrics and boosters
• On pediatric vaccines in particular, we were able to accelerate the delivery of pediatric doses following regulatory approval in November of last year, and we have now received 5.8 million pediatric doses, providing enough doses to fully vaccinate all eligible children 5 to 11 years old

If pressed on additional pediatric vaccines:

• on November 16, Health Canada received Moderna’s submission to approve its pediatric solution, which will target children from 6 to 11 years old
• clinical trials for pediatric solution targeting children from 6 months to 4 years old are still underway for both Moderna and Pfizer
• Public Services and Procurement Canada continues to engage suppliers on further supply of pediatric doses, including for children aged 6 months to 4 years old

If asked on delivery of pediatric doses for children:

• last year, Canada secured future supply deals with Pfizer and Moderna that include access to pediatric doses, in order to ensure that Canadian children will receive vaccines in a timely manner

If pressed on future Pfizer supply:

• in April 2021, the Prime Minister announced that Canada had secured a deal with Pfizer to ensure a guaranteed supply of 35 million doses for 2022, 30 million doses for 2023, as well as additional options for an additional 30 million doses in each of these years
• this deal also includes options for up to 60 million doses for 2024
• this agreement will ensure that Canada has access to future supply of a range of products, including pediatrics and boosters

If pressed on future Moderna supply:

• earlier this year, Public Services and Procurement Canada successfully secured an agreement with Moderna for 20 million doses with options for up to 15 million additional doses for both 2022 and 2023
• through this agreement, Canada will also have access to options for an additional 35 million doses in 2024
• this agreement will ensure that Canada has access to future supply of a range of products, including pediatrics and boosters

If pressed on the release of vaccine contracts:

• as permitted by contract and law, the Government of Canada is committed to transparency and accountability, and has been publicly disclosing contracting information to the fullest extent possible
• this includes working with vaccine suppliers to secure their agreement on publicly releasable versions of Canada’s vaccine contracts, while respecting our confidentiality agreements and protecting our negotiating position

If pressed on the details of advance purchase agreements:

• we continue to seek opportunities to be as transparent as possible about our procurements in support of Canada’s COVID-19 response, while respecting confidentiality agreements and protecting our negotiating position
• every contract is different as they reflect specific requests and requirements put forth by the supplier
• Public Services and Procurement Canada has worked with its vaccine suppliers to secure their agreement on publicly releasable versions of Canada’s vaccine contracts
• these documents fully respect the Access to Information Act, so information that is commercially confidential or that could impact Canada’s ability to negotiate future contracts has been protected
• as we have throughout the pandemic, Public Services and Procurement Canada will continue to openly communicate with Canadians about the work we are doing to support Canada’s pandemic response

Background

Overall, the federal government has allocated over $9 billion for vaccine procurement and Public Health Agency of Canada is responsible for managing this funding.

Currently, Pfizer, Moderna, AstraZeneca and Johnson & Johnson have been approved to prevent COVID-19. Medicago and Novavax have sent their final submission to Health Canada and are waiting for approval. Sanofi started the regulatory submission process for its primary COVID-19 vaccine. Through this process Health Canada will review the evidence of safety, efficacy, and manufacturing quality for each vaccine to determine whether individual vaccines will be approved for use in Canada, before they are used to vaccinate Canadians.

The Government of Canada has signed agreements in principle with the following companies to obtain access to their vaccines and vaccine candidates:

• AstraZeneca agreement was for 20 million doses and, in 2021, Canada received 3.8 million doses of the viral vector vaccine Vaxzevria for use in Canada. The remaining doses are being donated either through bi-lateral agreements or COVAX
• Sanofi and GSK, which will supply up to 72 million doses of their protein subunit vaccine candidate
• Johnson & Johnson agreement was for up to 38 million doses and, in 2021, Canada received 188,000 doses of its viral vector vaccine Ad26.COV2.S. Work is underway to donate Johnson & Johnson doses through COVAX
• Novavax, which will supply up to 76 million doses of its protein subunit vaccine candidate NVX-CoV2373 between 2022 and 2024
• Pfizer, supplied 51 million doses of its mRNA vaccine Comirnaty and 4 million pediatric doses in 2021. Agreement is in place for future supply of up to 185 million doses from 2022 to 2024
• Moderna supplied 34.9M million doses of its mRNA vaccine Spikevax in 2021. While 10M have been deferred to early 2022, agreement is in place for future supply of up to 95 million doses from 2022 to 2024
• Medicago, which will supply up to 76 million doses of its plant-derived Coronavirus Virus-Like Particle vaccine candidate (CoVLP) between 2022 and 2024
• Serum Institute of India/Verity Pharmaceuticals, which supplied 500,000 doses of the Oxford-AstraZeneca vaccine produced under license and marketed as COVISHIELD

Other key issues:

• Canada’s 7 main agreements with vaccine suppliers allows for donations to be made when doses are deemed surplus in-country. PSPC supports Global Affairs Canada and Public Health Agency of Canada on the donation of surplus doses through its agreements with suppliers through direct donations and the COVAX facility
• Canada signed an agreement on September 18, 2020 to participate in the COVAX Facility, which supports equitable global access to safe, effective, and affordable COVID-19 vaccines. Through this agreement Canada has committed to being a global leader in supporting equitable global access to safe, effective, and affordable COVID-19 vaccines. As a result of bilateral negotiations led by Innovation, Science and Economic Development for its vaccine candidate, Novavax agreed to enter into separate negotiations to build domestic capacity in Canada in the long-term. Canada will be enhancing its domestic capacity through this partnership, operating out of the National Research Council’s Royalmount facilities in Montreal
• Health Canada identified a need for a vendor-managed stockpile of critical drugs in anticipation of possible shortages related to the COVID-19 pandemic. The reserve is accessible to the provinces and territories to ensure hospitals have adequate supply of 12 key drugs, which are being allocated on a regular basis based on provincial and territorial needs
• the default position of the Government of Canada in all its procurement contracts is that title to intellectual property remains with the contractor, which is set out in the Policy on Title to Intellectual Property Arising Under Crown Procurement Contracts. In the advance purchase agreements that Canada negotiated with vaccine manufacturers, the manufacturers retain the title to intellectual property and do not grant a license for Canada to use the intellectual property nor give Canada a right to use the intellectual property

Key points vaccine portfolio

Procurement strategies for variant-specific vaccines

• We are continuing to evolve our vaccine procurement strategy based on the best scientific advice available, which includes working with vaccine suppliers to secure new formulations for variants, boosters and pediatrics as they become available
• In order to ensure that Canadians have access to the latest vaccine formulations available, including variant-specific vaccines, Canada secured access to future supply of Moderna and Pfizer
  • Both agreements provide Canada with access to the latest vaccine formulations available throughout 2022 to 2023, including options to access additional doses in 2024
• Combined, these future supply deals provide Canada with the flexibility required to draw its supply from the latest vaccine formulations, especially as new products such as variant-specific vaccines are approved for use
• In light of the Omicron variant and recent developments on booster recommendations, Public Services and Procurement Canada continues to work with suppliers to ensure that there is an adequate supply of vaccines to administer to Canadians based on the modelling of the health portfolio

Background

Future Pfizer supply:

• in April 2021, the Prime Minister announced that Canada had secured a deal with Pfizer to ensure a guaranteed supply of 35 million doses for 2022, 30 million doses for 2023, as well as additional options for an additional 30 million doses in each of these years
• this deal also includes options for up to 60 million doses for 2024

Future Moderna supply:

• in early 2021, Public Services and Procurement Canada successfully secured an agreement with Moderna for 20 million doses with options for up to 15 million additional doses for both 2022 and 2023
• through this agreement, Canada will also have access to options for an additional 35 million doses in 2024

Domestic manufacturing capacity of vaccines

• Public Services and Procurement Canada continues to provide support to colleagues at the Department of Innovation, Science and Economic Development as they lead on the government’s efforts to enhance Canada’s domestic manufacturing capacity for vaccines

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