Question Period Note: Procurement of COVID-19 vaccines

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

Note: All questions regarding the rolling regulatory review of vaccines would be directed to Health Canada.

• Given intense global competition, the Government has taken an aggressive approach to secure access to 256 million doses, 132 million of which have received regulatory approval
  • By the end of September, Canada will have received enough doses for every eligible person who wants one
  • As an ongoing priority, PSPC continues to work with vaccine suppliers to negotiate the early delivery of doses to Canadians

If pressed on the details of advance purchase agreements:

• 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
• We continue to seek opportunities to be as transparent as possible about our procurements in support of Canada’s COVID 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
• As part of our commitment to transparency, PSPC 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
• This approach allows us to release as much information as possible without compromising our existing agreements or our ability to keep Canadians safe
• 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

If pressed on contract clauses and Intellectual Property:

• 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

If pressed on spending on vaccines:

• Starting last year, we invested a little over $1 billion in upfront payments to suppliers in order to support vaccine development, testing and at-risk manufacturing prior to regulatory approval
• Overall, the federal government has allocated over $9 billion for vaccine procurement. PHAC is the organization responsible for managing this funding profile as the client department
• We are unable to disclose specific financial details due to confidentiality terms within our agreements. We will continue to provide Canadians with as much information as possible and as our vaccine strategy unfolds

If pressed on the price of AstraZeneca’s vaccine:

• We are unable to disclose specific financial details such as pricing due to the confidentiality terms within our agreements
• For its COVID-19 vaccine, AstraZeneca operates on a not-for-profit pricing model
• We fully support the release of contract details that do not harm Canada’s capacity to secure doses for Canadians and continue to work with suppliers to release as much information as possible

If pressed on the executive order in the US:

• Suppliers have indicated that the Executive Order has not changed their existing arrangements with countries like Canada and they will continue to work towards target delivery dates
• Canada does not anticipate any disruption of COVID-19 vaccine supplies as a result of the Order and is working closely with officials at Global Affairs Canada to monitor the situation
• With its diverse portfolio of vaccine candidates, Canada continues to work with suppliers to maintain supply of vaccine shipments, especially as supply ramps up in the coming months

If pressed on European Union (EU) export controls:

• Canada is closely monitoring the situation in the EU following the extension of its export transparency mechanism for COVID-19 vaccines produced within its borders
• Since these measures were first introduced, Canadian officials have been working with suppliers and EU officials to ensure that there will be no disruptions of vaccine exports to Canada
• Minister Ng’s counterparts have assured her that these measures will not affect vaccine shipments to Canada, and our government has been in constant contact with our counterparts in the EU and its member states at all levels of government
• We will continue to work closely with suppliers to ensure that Canada’s vaccine supply from Europe continues to arrive without any delays

If pressed on new variants and boosters:

• Canada is engaging its vaccine suppliers to ensure that we mitigate any emerging risks in the face of these new variants and continues to evolve its procurement strategy around future supply based on the best scientific advice available
• We are actively negotiating for boosters with our suppliers and will factor this into our planning
• PSPC procures vaccines based on requests from the Public Health Agency of Canada, which are informed by the COVID-19 Vaccine Task Force. This includes monitoring the effectiveness of our current vaccine portfolio through clinical trials on the new variants

If pressed on contractual implications of off-label use:

• Canada’s priority remains to ensure that the vaccines in its portfolio are administered in a safe and effective manner
• We continue to engage suppliers to secure early delivery of vaccine doses

If pressed on delivery of AstraZeneca doses:

• Following the regulatory approval of the AstraZeneca vaccine on February 26th, Canada is expecting to receive all 20 million doses of its bi-lateral agreement by the end of the year
• PSPC is now anticipating a first shipment of 1 million doses to arrive later in June as part of this bilateral agreement

If pressed on AstraZeneca doses offered by the United States:

• Canada received 1.5 million doses of AstraZeneca from the United States in the week of March 26th, which were immediately distributed to provinces following regulatory approval
• Through this exchange, the 1.5 million doses will count as part of Canada’s 20 million doses secured through its bilateral agreement with AstraZeneca. Canada will provide an equal number of doses to the U.S. at a later date

If pressed on delivery of Johnson & Johnson:

• A first shipment of over 300,000 doses from Johnson & Johnson arrived in Canada on April 28th. Health Canada has since determined that it will not release these doses for use in Canada
• These steps were taken to ensure that all vaccines meet Canada’s high standards for quality, safety and efficacy
• We continue to work with the supplier to firm up a delivery schedule for doses from Johnson & Johnson and expect another shipment to arrive by the end of the month. Health Canada approval of the product is required prior to any release to the public

If pressed on supply of contaminated vaccines from Emergent facility in US:

• We have confirmation from AstraZeneca that no vaccines imported in Canada were impacted by this issue

If pressed on accelerated delivery of doses:

• PSPC continues to work with suppliers to successfully accelerate the delivery of vaccines so that Canada meets its target of providing a vaccine to all Canadians who want one by the end of September
• On April 16th, Canada announced that it will be receiving an additional 8 million doses of the Pfizer vaccine, which were secured as options through Canada’s existing agreement. This includes 4 million doses that were delivered in May, as well as an expected delivery of 2 million doses in June and 2 million doses in July
• During the week of May 17th, it also was announced that 3 million Pfizer doses will be accelerated for early delivery into July. This additional acceleration means that from April to July, we are set to receive at least 29 million doses of Pfizer vaccine alone
• Other successful efforts to accelerate Pfizer and Moderna doses have yielded positive results. Canada is now on track to receive all 51 million of its Pfizer doses and all 44 million of its Moderna doses before the end of September

If pressed on Pfizer supply:

• Building on Canada’s successful negotiations to accelerate deliveries of the Pfizer vaccine, Canada will receive weekly allocations of over 2 million Pfizer doses alone, which will continue through to the end of August
• On June 4th, the Prime Minister also confirmed that Canada has negotiated an additional 3 million Pfizer doses to be delivered in September
• This stable supply is a result, in part, of the flexibility that Canada has built into its agreements to ensure that it is positioned to accommodate doses as quickly as possible from a diverse global supply-chain

If pressed on delay of Pfizer supply in July:

• Pfizer has notified us of a slight disruption to its shipments in early July due to efforts to continue to scale production facilities to meet global demand
• As a result, Canada will receive smaller shipments in early July, however Pfizer will ramp up supply to meet its 9.1 million target by the end of the month

If pressed on Moderna shipment:

• On June 18th, it was announced that Moderna will deliver another 11.6 million doses in July, 5 million of which will arrive at the end of June
• This news of a further acceleration in deliveries comes in addition to the June 9th announcement that Moderna will deliver an additional 7 million doses in the month of June.
• These respective accelerations are the result of strong collaboration with Moderna, who will provide the doses from its US facilities
• PSPC continues to work with Moderna to ensure that all of the 44 million doses of its COVID-19 vaccine that Canada has purchased will be delivered by September
• This positive news follows disruptions that Moderna faced as a result of its efforts to scale production capacity starting back in April

If pressed on the additional 1 million Moderna doses from the US

• Canada has signed a collaborative agreement to receive an additional 1 million doses of Moderna from the US government. This agreement is part of the broader pledge by the US to share vaccines to the world
• This will not impact Canada’s bi-lateral agreement with Moderna

If pressed on Canada’s agreement for 2 million doses from the Serum Institute of India:

• Canada successfully completed an agreement for 2 million doses of AstraZeneca’s COVID-19 vaccine, which is manufactured under license by the Serum Institute of India and distributed under the label COVISHIELD
• 500,000 of these doses arrived in Canada the week of March 1, and have been distributed to provinces and territories. We continue to work with the supplier on the delivery of the remaining 1.5 million doses
• This agreement for 2 million doses is in addition to the 20 million doses already secured through Canada’s agreement with AstraZeneca

If pressed on India’s export ban on vaccines (Serum):

• We have been notified that there may be a delay on the remaining shipment of doses from the Serum Institute, however it has indicated its commitment to meeting its contractual obligations to Canada
• This delay is a result of India’s shift to focus on the needs of its domestic needs amidst rising rates of infections

If pressed on Canada’s participation in the COVAX Facility:

• Canada signed an agreement on September 18th to participate in the COVAX Facility, which supports equitable global access to safe, effective, and affordable COVID-19 vaccines, once developed
• This will allow us to diversify our portfolio of vaccine candidates, provide an additional mechanism to donate or sell surplus doses to other nations, potentially secure earlier access to vaccine doses, and reduce the risk of export controls preventing delivery of doses to Canada
• Through this agreement, Canada will also have access to up to 15 million vaccine doses, if required, while supporting equitable global access to safe, effective, and affordable COVID-19 vaccines
• PSPC continues to work with COVAX and AstraZeneca to finalize the delivery details for the remainder of its allocation of up to 5 million AstraZeneca doses, which started with an initial shipment of approximately 300,000 doses that arrived on April 8th
• Canada received another shipment of 655,000 AstraZeneca doses through COVAX on May 13th and continues to work on finalizing the remaining 652,000 doses that are anticipated in quarter 2
• These doses would come in addition to the 20 million doses that Canada has secured through its bi-lateral agreement with AstraZeneca
• Canada is committed to global collaboration to end this pandemic and is contributing $220 million through the COVAX Advance Market Commitment to purchase doses for low- and middle-income countries
• On June 13th, the Prime Minister announced that Canada will be donating 13 million surplus doses of Canada’s COVAX allocation to help the world get immunized against COVID-19

If pressed on impact of India’s export ban on AstraZeneca doses from COVAX:

• Canada’s allocation will not be supplied through India so it is not expected that these events will affect its initial shipments

If pressed on Novavax production in Canada (Innovation Science and Economic Development Canada):

• As a result of bilateral negotiations led by Innovation, Science and Economic Development Canada for its vaccine candidate, Novavax agreed to enter into separate negotiations to build domestic capacity in Canada in the long-term
• As a result of these efforts, Canada will be enhancing its domestic capacity through this partnership with Novavax, operating out of the National Research Council’s Royalmount facilities in Montreal

If pressed on Pfizer’s change from 5 to 6 doses per vial:

• On February 9th, Canada authorized Pfizer to change the product monograph and label for its COVID-19 vaccine to reflect that each vial contains 6 doses of vaccine
• Canada’s contract with Pfizer is based on the number of doses and must be aligned with the applicable legislation and regulatory framework. As such, we continue to monitor the situation with our colleagues at Health Canada in order to ensure that the requirements are consistently met and Canada receives the supply that it has been promised in its contract
• To extract a 6th dose reliably and consistently the Government of Canada has already ordered 160 million low dead volume syringes, which are recommended in the case of a change from 5 to 6 doses per vial
• The first deliveries have already arrived in Canada and will continue through August 2021

If pressed on provincial and territorial collaboration:

• From the outset, the Government of Canada has been working directly with provincial and territorial governments to ensure that we are considering their needs
• We are in regular contact with provincial and territorial counterparts to ensure that we are working cohesively and collaboratively, and that they are getting the support they need

Note: for all therapeutic solutions, questions about allocation and distribution should be directed to PHAC.

If pressed on Roche’s Regeneron therapeutic:

• On June 11, Canada put a contract in place with Roche for its Regeneron therapeutic drug for 9,000 doses, which is enough for 9,000 treatments
• Health Canada approved Regeneron for use in Canada on June 9, 2021

If pressed on the Remdesivir therapeutic:

• Canada has a contract in place with McKesson/Gilead for the Remdesivir therapeutic drug for up to 150,000 doses, which is enough for up to 25,000 treatments
• Gilead allocates this product based on countries with the highest burden of disease, in order to ensure that it is distributed in a fair and equitable manner

If pressed on Roche’s Tocilizumab therapeutic:

• Last month, Canada finalized an agreement with Roche Canada for the off label use of Tocilizumab therapeutic solution for the treatment of COVID-19 pneumonia
• The distribution of this treatment is determined by a global allocation framework that ensures equitable distribution and access around the world. Each month, Canada is informed of available allocations by the supplier, and continues to receive updates on a regular basis
• Tocilizumab is being used as an off-label solution to treat COVID-19 pneumonia and, as such, Roche has indicated that it is carefully managing supply to ensure that there is sufficient stock for on-label use in Canada and other countries

If pressed on the purchase of Eli Lilly’s antibody treatment:

• Canada signed an initial order of up to 26,000 doses of Eli Lilly’s antibody treatment, Bamlanivimab, and secured the ability to buy additional doses on a monthly basis if required
• Canada put in place a flexible contract for this solution so that, following its initial order, any additional purchases can be made based on monthly demand from provinces and territories
• Canada has no obligation to buy additional doses at the current time
• The treatment was developed in partnership with Canadian company AbCellera, combining its advanced antibody therapy discovery platform with Eli Lilly’s manufacturing and distribution capability

If pressed on critical drug shortages:

• Health Canada has 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

If pressed on National Security Exception (NSE) contracting:

• The NSE is invoked to remove procurements from the obligations of Canada’s trade agreements for reasons of national security
• In the case of COVID-19, after the World Health Organization declared the pandemic, PHAC made a request on behalf of the federal government that PSPC invoke the NSE with respect to the acquisition of goods and services required to respond to the COVID-19 pandemic

If pressed on the purchase of Ultra-Low Temperature freezers:

• Contracts have been issued for the purchase of 600 freezers. Deliveries started in November and we have received 568 freezers as of June 18, 2021
• Contracts have been issued for the purchase of 100 refrigerators. Deliveries started in February and we have received all 100 refrigerators as of April 14, 2021

If pressed on the purchase of dry ice:

• PSPC has put in place 10 standing offers for the delivery of an estimated 30,000 kilograms of dry ice, on an as needed basis, to provinces and territories

If pressed on syringes:

• PSPC has put contracts in place for the purchase of 180 million low-dead volume syringes

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

• AstraZeneca, which will supply 20 million doses of its viral vector vaccine candidate ADZ1222 and up to an additional 5.08 million doses as part of Canada’s COVAX allocation of the AstraZeneca vaccine
• Sanofi and GSK, which will supply up to 72 million doses of their protein subunit vaccine candidate
• Johnson & Johnson, which will supply up to 38 million doses of its viral vector vaccine candidate Ad26.COV2.S
• Novavax, which will supply up to 76 million doses of its protein subunit vaccine candidate NVX-CoV2373
• Pfizer, which will supply up to 76 million doses of its mRNA vaccine BNT162
• Moderna, which will supply 44 million doses of its mRNA vaccine mRNA-1273
• Medicago, which will supply up to 76 million doses of its plant-derived Coronavirus Virus-Like Particle (CoVLP)
• Serum Institute of India/Verity Pharmaceuticals which will supply 2 million doses of the Oxford-AstraZeneca vaccine produced under license and marketed at COVISHIELD

Currently, Pfizer, Moderna, AstraZeneca and Johnson & Johnson have been approved to prevent COVID-19. Many vaccines are in clinical trials or under development. When additional studies have been completed, 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.

COVID-19 Vaccine Task Force

The COVID-19 Vaccine Task Force, supported by a secretariat housed at the National Research Council of Canada, provides advice to the Government of Canada on COVID-19 vaccines, which can include the following:

• Prioritizing vaccine projects seeking support for activities in Canada
• Attracting to Canada promising non-Canadian vaccine candidates, or partnering with developers of non-Canadian vaccine candidates
• Optimizing the tools needed to develop vaccines
• Supporting effective research and development, and supply chain coordination for COVID-19 vaccine projects
• Facilitating solutions to manufacture the most promising COVID-19 vaccines in Canada
• Identifying opportunities to enhance business connectivity globally to secure access to vaccines with key commercial sponsors

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