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 prepare for the procurement of COVID-19 vaccines and related supplies.

Note: All questions regarding the rolling regulatory review of vaccines (including the latest on AstraZeneca) would be directed to Health Canada.

• Given intense global competition, the Government is taking an aggressive approach to secure access to very promising vaccine candidates so that Canada is prepared to deliver vaccines to its citizens as quickly as possible
  • On behalf of PHAC, based on recommendations from the COVID-19 Vaccine Task Force, we have already established agreements with AstraZeneca, Sanofi and GlaxoSmithKline, Novavax, Johnson & Johnson, Pfizer, Medicago and Moderna to secure access to a total of 214 million doses, and up to 414 million doses if all options and all agreements are exercised
  • I would like to thank the members of the COVID-19 Vaccine Task Force for their expert advice, as we work toward securing future vaccines to protect Canadians

If pressed on public statements that the U.S., U.K. and Germany will receive doses before Canada:

• The Government of Canada has secured agreements to secure access to 7 very promising vaccine candidates across the world
• Health Canada will conduct a rigorous assessment of each vaccine candidate before it is authorized for use in Canada
• On December 7, the Prime Minister announced that Canada will receive up to 249,000 doses of Pfizer’s vaccine candidate during the month of December
• This announcement follows Canada’s successful negotiations with suppliers for early doses. Pfizer continues to work with territorial and provincial representatives to prepare for the distribution of its vaccine
• Based on the access that Canada has secured to early doses, it is anticipated that delivery of vaccines will begin during the week of December 14, following confirmation from Pfizer that vaccine shipments from Europe will begin on Friday, December 11

If pressed on the details of advance purchase agreements:

• To date, the Government of Canada has allocated approximately $1 billion for the 7 agreements that are in place
• This includes some upfront payments that the pharmaceutical companies require to support vaccine development, testing and at-risk manufacturing prior to regulatory approval
• While not fully recoverable, these payments facilitate Canada’s earliest possible place in production runs
• We are in constant contact with provincial and territorial counterparts to ensure that we are working cohesively and collaboratively, and that they are getting the support they need

If pressed on the status of clinical trials or regulatory approvals:

• We are all eager to deliver safe and effective vaccines to Canadians as soon as possible, and that is exactly what we are working on every single day
• As you are aware, clinical trials for these vaccine candidates are ongoing and any vaccines require Health Canada approval
• While Health Canada will be expediting the review of vaccines for COVID-19, this will be done without sacrificing standards for safety, efficacy and quality
• In particular, it is important that there is evidence from large clinical trials that demonstrate that the vaccine can provide protection from infection
• AstraZeneca, Moderna, Janssen and Pfizer have all started Health Canada’s rolling regulatory review, with the aim of having a safe and effective vaccine ready for Canadians as soon as possible.
• On December 10, Pfizer became the first vaccine candidate to obtain regulatory approval in Canada

If pressed on Pfizer’s supply chain issues:

• The reports of supply chain issues surrounding the Pfizer vaccine are not unexpected during this unprecedented time
• Despite these issues, Pfizer is on track to deliver the first early doses of its vaccine, after obtaining regulatory approval on December 10
• That is also why Canada has invested in one of the most diverse COVID-19 vaccine portfolios in the world

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
• With its diverse portfolio of vaccine candidates, Canada is not tied to any single manufacturing site and will also be receiving supplies from Europe

If pressed on AstraZeneca, Moderna and Pfizer’s successful clinical trials:

• We were pleased to hear the news on AstraZeneca, Moderna and Pfizer’s successful clinical trials to date
• All 3 of these suppliers are manufacturing doses to ensure that delivery can start shortly after obtaining Health Canada approval
• As the first candidate to obtain Health Canada approval, Pfizer will begin delivering its doses to Canada the week of December 14
• While this is a positive step forward we will continue to monitor the progress of all vaccine candidates in the context of Health Canada’s review to ensure that the solutions are safe for all Canadians

If pressed on the purchase of options for Moderna’s vaccine candidate:

• Given the strong progress made by Moderna in its clinical trials to date, Canada exercised its option to purchase an additional 20 million doses of its vaccine candidate
• These additional doses will position Canada to deliver vaccines to another 10 million Canadians, once Moderna has obtained regulatory approval

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

• Canada supports the objectives and principles of the COVAX Facility, which supports equitable global access to safe, effective, and affordable COVID-19 vaccines, once developed
• On September 18, Canada signed an agreement to participate in the COVAX Facility
• 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
• This facility allows us to accomplish together what none of us could accomplish alone

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

If pressed on whether Canada will have adequate amounts of influenza vaccine doses:

• The Government of Canada buys influenza vaccines on behalf of provincial and territorial governments, who determine the number of seasonal influenza vaccine doses purchased each year
• Canada usually orders around 11 million doses each year. However, due to the COVID-19 pandemic, it is anticipated that more Canadians may wish to receive the seasonal flu vaccine this year
• In order to meet this increased demand, we have secured access to 15.6 million doses of flu vaccine already – approximately 40% more than last year – and we continue to seek opportunities to securing additional quantities
• Five manufacturers are under contract to provide these doses. Approximately 14.2 million doses have been delivered to the provinces and territories, with the remainder to be delivered by the end of December

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

• Canada is also working on securing promising and effective therapeutic treatments for COVID, having signed an initial order of up to 26,000 doses of Eli Lilly’s antibody treatment over the next 3 months and the ability to buy additional doses on a monthly basis
• The treatment has the potential to help patients with mild or moderate COVID-19 who are at risk of progressing to severe illness by improving symptoms more quickly and keeping them out of hospital
• Health Canada granted interim authorization for Eli Lilly’s treatment on November 20th, making it the first antibody treatment approved for use in Canada under Health Canada’s interim order to expedite the review and authorization of COVID-19 drugs
• 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 would be accessible to the provinces and territories to ensure hospitals have adequate supply
• PSPC issued a Request for Proposals (RFP) for 8 critical drugs on November 13, 2020. The RFP was issued directly to licensed pharmaceutical suppliers and closed on December 2 with 14 bids received
• Bid evaluations are underway with contract awards anticipated by December 18, 2020
• Health Canada also requested that PSPC issue a second RFP for an additional 5 drugs with contract awards targeted for January 15, 2021
• For each drug, PSPC expects to award contracts to 2 to 4 suppliers
• Suppliers will be required to store, rotate and deliver the drugs to the final destination
• PSPC will be providing “order desk” services to the provinces and territories in support of the reserve

If pressed on material shortages:

• The Government of Canada is purchasing supplies from a number of sources and countries, both internationally and domestically

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 (WHO) declared the pandemic, PHAC made a request on behalf of the federal government that PSPC invoke the National Security Exception with respect to the acquisition of goods and services required in order to respond to the COVID-19 pandemic
• Some of the procurements being carried out in response to COVID-19 are being done under a NSE, meaning that many solicitation documents are not published on Buy and Sell. This allows us to move rapidly as we purchase goods and services to protect the health and safety of Canadians as we face this pandemic
• In line with our commitment to transparency, we have published information on COVID-19-related contracts on the PSPC website

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

• It is critical that vaccines are distributed and stored within their indicated temperature requirements, so we are making preparations for potential candidates
• The Government of Canada is actively pursuing the purchase of Ultra-Low Temperature freezers to assist with the distribution and storage of vaccines in Canada
• Contracts have been issued for the purchase of 62 -80 degree freezers, 100 -20 degree freezers, 130 countertop freezers and 148 portable freezers. Deliveries started the week of November 23

If pressed on the purchase of dry ice:

• A Request for Standing Offer was published on our Buy and Sell website for dry ice. The intent of this tender is to establish a list of prequalified suppliers across the country that can provide dry ice when and where it will be required. The tender closed on November 30. We are currently proceeding with the evaluation to award up to 11 standing offers. As December 11, 5 standing offers were awarded for dry-ice

If pressed on vaccine logistics:

• The Government of Canada has successfully secured an end-to-end logistics solution that will support the physical distribution of vaccines to provincial and territorial authorities or points of administration
• Following the release of an Invitation to Qualify for this solution, the Government finalized a shortlist of 4 Pre-Qualified Bidders:
• UPS Healthcare
• McKesson Canada Corporation
• Kuehn + Nagel Ltd
• Federal Express Canada Corp. and Innomar Strategies Inc.
• The Government launched a competitive Request for Proposal amongst the Pre-Qualified Bidders. Further to that process, a contract for up to $90.4 million, including taxes, was awarded to Federal Express Canada Corp. and Innomar Strategies Inc. in Joint Venture on December 4, 2020

If pressed on potential delays to Sanofi/GSK:

• Canada is monitoring any potential delays arising from trials of Sanofi’s vaccine candidate
• Our priority is the health and safety of Canadians and as such, no vaccine will be delivered prior to obtaining regulatory approval
• Canada has invested in one of the most diverse COVID-19 vaccine portfolios in the world to mitigate the risk of delays such as this, and continues to monitor the progress of all candidates in the context of regulatory reviews

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

• AstraZeneca, which will supply up to 20 million doses of its viral vector vaccine candidate ADZ1222
• Sanofi and GSK, which will supply up to 72 million of doses of their protein subunit vaccine candidate. The agreement with GSK secures their established pandemic adjuvant technology that will help the Sanofi vaccine produce a stronger immune response
• 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 candidate, BNT162.
• Moderna, which will supply up to 56 million doses of its mRNA vaccine candidate mRNA-1273
• Medicago, which will supply up to 76 million doses of its plant-derived Coronavirus Virus-Like Particle (CoVLP)

Currently, Pfizer is the only vaccine that has 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

The COVID-19 Vaccine Task Force will be in place for a period of at least 12 months, subject to extension at the discretion of the Government of Canada.

Critical drug shortages

PSPC issued a RFP for 8 drugs on November 13th, 2020. The RFP was issued directly to licensed pharmaceutical suppliers and not publically posted. The RFP closed on December 2nd and 14 bids were received. The bid evaluations are underway and contract award is anticipated by December 18th, 2020.

PSPC issued a second RFP on behalf of Health Canada on December 4th, 2020 which is closing on December 18th, 2020, for an additional 5 drugs with contract award targeted for January 15th, 2021.

For each drug, PSPC is planning to award contracts to 2 to 4 suppliers.

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