Standing Committee on Health (HESA) Appearance, February 2021

 

Mr. Mitch Davies, President of the National Research Council Standing Committee on Health (HESA) Appearance

Study of the Emergency Situation facing Canadians in Light of the Second Wave of the COVID‑19

February 22, 2021 10:58 a.m. to 1:06 p.m

Notes

  • Opening Remarks
  • NRC's COVID‑19 Response – Key Facts
  • NRC COVID‑19 Investments
  • CanSino – Questions and Answers

House of Commons Standing Committee on Health Study

Remarks Delivered by NRC President Mitch Davies

Meeting Date: February 22, 2021

NRC's COVID‑19 Response – Key Facts

Prepared by SGO

Since March 2020, the NRC has supported the Government of Canada's COVID‑19 response to help protect the health and safety of Canadians.

Key NRC Data Organized by Public Health‑Related Topics & NRC Supported Response Measures

1) Public Health‑Related Topics

Testing and Diagnostics

  • Supplying high quality SARS‑CoV‑2 spike protein - 50 different organizations have received the spike protein for R&D testing
  • Supply chain solutions – NRC expects to produce > 56,000L of buffer for NML / national testing labs by March 2021
  • Mechanical swab testing to support PHAC and swab producing firms – potential capacity of 2M/week
  • Open challenge under the Pandemic Response Challenge Program for a saliva based instrument‑less diagnostic test – 3 projects
  • NRC IRAP work includes:
    • Supporting 9 Canadian companies developing swabs with advisory services to facilitate Health Canada authorization of their products; and helping to establish and support clinical trials for 8 firms through $740K in funding (ongoing)
    • Providing advisory services and more than $4M in funding to Canadian companies to support the development of test kits and test kit components for COVID‑19 testing
    • Holding the following testing and diagnostics focused NRC‑IRAP ISC COVID‑19 Challenges:
      • Point of care: 4 firms supported
      • Magnetic reagents: 1 firm supported

PPE

  • Ensuring the safety and effectiveness of PPE – Metrology has tested 5010 unique samples representing 120 million PPEs which has supported more than 40 clients including 12 new domestic PPE manufacturers.
  • NRC IRAP has been working closely with OGDs to ensure that Canada has a safe and reliable domestic PPE supply and plan for future pandemic needs. This has included:
    • Analyzing the Canadian manufactured PPE supply landscape to identify gaps, with a primary focus on face shields / goggles, gowns / coveralls, surgical masks, N95 respirators, and gloves
    • Providing advisory services to SMEs and financial support to 5 firms to develop or improve their PPE offerings and production capacity. IRAP has worked with more than 70 companies in its PPE efforts.
    • Working with PHAC and HC to develop recommendations for shelf life testing of PPE
    • Holding the following PPE focused NRC‑IRAP ISC COVID‑19 Challenges:
      • Filtration material challenge: 3 firms supported for Phase 1; 2 firms then advanced and completed Phase 2
      • Compostable disposal surgical mask challenge: proposals under review
      • Recycling technologies for disposable (single‑use) PPE challenge: proposals under review.

Vaccines and Therapeutics

  • Vaccine candidate development collaborations (VBI, VIDO and others)
  • Therapeutics candidate development collaborations (JN Nova, University of Ottawa and others)
  • Production of virus stocks and support for pre‑clinical development and lead candidate selection
  • Clinical Trial Material Facility – 500 litres/month GMP capacity for clinical studies once constructed and operational >> will support Canadian SMEs to advance vaccines and biologics to clinical trials
  • Biologics Manufacturing Centre – 4000 litres/month GMP capacity once constructed and operational >> production of approximately 2 million doses per month (*Number of doses produced can vary dramatically depending on the specific vaccine and the manufacturing platform, as well as the complexity of the manufacturing process)
  • R&D funding to support early stage development of COVID‑19 vaccines and therapeutics in response to COVID‑19 – 10 projects approved (NRC‑IRAP Vaccines and Therapeutics)
  • NRC IRAP is working with ISED to provide support to 3 innovative SMEs to scale up production facilities and increase Canada's bio manufacturing capacity

Tracking and Modelling

  • Low‑cost sensor challenge – 2 firms supported (NRC‑IRAP ISC COVID‑19 Challenges)
  • Intelligent Data Clearing House challenge – 4 firms supported (NRC‑IRAP ISC COVID‑19 Challenges)
  • ISC COVID‑19 Testing Stream – 2 firms supported – NRC has been matched to test two projects related to tracking

Supporting our Clients

  • The NRC IRAP budget has more than doubled in 2020‑21 (> $800M) vs. 2019‑20 ($364M)
  • Liquidity provided to innovative, early‑stage companies through the Innovation Assistance Program (IAP): See below
  • As of December 31, 2020 NRC IRAP has (excluding IAP):
    • Started 19% more new projects vs same period last fiscal (April – December)
    • Provided support to 15% more firms
    • Offered 33% more advisory services
    • Supported 26% more jobs
  • > 3000 COVID related advisory services provided this fiscal year to date (January 2021) which, as examples, has supported Canadian SMEs in obtaining HC approval for test kits, helped with supply chain challenges and led to the development of HC‑approved ventilator prototypes
  • 763 youth placements have been created under the NRC IRAP Youth Employment Program ($15M)

Supporting the Community

  • In the spring and summer, the NRC responded to 900+ requests for technical advice and short‑term support to companies
  • PPE donations to frontline healthcare workers - 8,500 N95s, 180 coveralls, 350,000 gloves

Protecting NRC Employees

  • 67% working full‑time from home, 20% working part‑time from home, and 13% working onsite full‑time (as of January 22, 2021)

2) NRC Supported Response Measures

Pandemic Response Challenge Program - $15M

(As of February 16, 2021)

  • 40 projects on‑boarded in total under four program streams with 16 more under development
    • Rapid detection and diagnosis;
    • Therapeutics and vaccine development;
    • Digital health; and
    • Enabling adaptive responses
  • Grant funding agreements signed – 10 (~$1.2M), with 12 in development

NRC IRAP- ISC COVID‑19 Challenges Program

  • $15M announced in March 2020 for FY21
  • Another $15M awarded in the fall – over 2 fiscal years
  • 14 firms supported to date
Table 1

Challenge

Date Closed

Firms Supported (as of February 16, 2021)

Compostable disposal surgical masks and respirators

Nov 17

Under review

Recycling technologies for disposable (single‑use) PPE

Nov 6

Under review

Magnetic reagents for detection of COVID‑19

June 16

1

Intelligent Data Clearing House

June 2

4

Low‑Cost Sensor Challenge

April 21

2

Diagnostic Kit Challenge

April 21

Phase 1: 4
Phase 2: 1

Made in Canada Filtration Material for the Manufacture of N95 Respirators and Surgical Masks

April 17

Phase 1: 3
Phase 2: 2

Innovation Assistance Program - $250M, plus an additional $155M, in liquidity provided to innovative, early‑stage companies

(As of February 16, 2021)

IAP Round 1 - $250M

  • > $247M disbursed
  • 2237 firms supported
  • > 26,000 jobs supported

IRAP Round 2 - $155M (For eligible Round 2 recipients, an additional 12 weeks have been added to the program, extending support to March 13, 2021)

  • $103.4M committed (contracted)
  • $88.1M disbursed
  • 1173 firms supported
  • > 4700 jobs supported

Support for Early Stage Development of COVID‑19 Vaccines & Therapeutics - $150M

  • $150M over 3 years

(As of January 22, 2021)

  • Vaccines: 9 vaccine funding applications received from ISED/SIF- 6 projects approved ($23.2M)
    • Immunovaccine Technologies Inc. (Dartmouth, N.S.)
    • Entos Pharmaceuticals (Edmonton, Alta.)
    • Providence Therapeutics COVID Inc. (Toronto, Ont.)
    • Glycovax Pharma (Montreal, Que.)
    • Symvivo (Burnaby, B.C.)
    • Biodextris Inc. (Laval, Que.)
  • Therapeutics: 16 therapeutics applications received from ISED/SIF - 4 projects approved ($9.2M)
    • Bold Therapeutics (Vancouver, BC)
    • JN Nova Pharma (Montreal, Que.)
    • Laurent Pharmaceuticals (Montreal, Que.)
    • Qu Biologics (Vancouver, BC)

Biologics Manufacturing Centre - $126M

(As of February 16, 2021)

  • The construction of the building is on track – shell completed on schedule on December 31, 2020 and interior progressing well
  • The DG for the BMC as well as 7 of the eight leads have been hired (QA, QC, Regulatory Affairs, Operations Production, Supply Chain and Warehouse, Business Development and Technology Transfer and Engineering & Maintenance).
  • Consultations with 33 organizations from key stakeholder groups were completed in December 2020 to gather input on governance and operational models for the operations of the facility
  • Project advisory board established – kick‑off meeting took place on January 29th
  • An MOU between Canada (ISED, PHAC, NRC) and Novavax was signed in January to explore options for production of the Novavax COVID‑19 vaccine at the BMC

NRC Clinical Trial Material Facility - $44M

(As of February 16, 2021)

  • Proposed GMP upgrades to produce vaccines for clinical trials
  • The final design and engineering work are being completed with input from GMP experts, for construction of the permanent clinical trial production facility to support vaccines and biologics research and development. Once these plans are finalized, a revised timetable will be published in the near future for the construction and operationalization
  • To ensure effective project delivery, an Oversight Committee has been established
  • Once operational, the facility will have the capacity for up to 500L production & purification for protein, viral vector, and virus‑like particle vaccines & antibodies

Enhanced Student Opportunities - $7.5M

  • As of January 31 2021, 134 hiring opportunities underway with additional hiring anticipated in 2021‑2022

NRC COVID‑19 Investments

NRC Response to COVID-19

Qs & As

NRC/CanSino partnership
COVID‑19 vaccine candidate

Q1. What was the purpose of the agreement with CanSino?

On May 6, 2020, the NRC signed a new collaboration agreement with CanSino Biologics Inc. to advance a high‑potential vaccine candidate against COVID‑19 in Canada, known as Ad5‑nCoV. At that time, CanSino's vaccine candidate was recognized internationally as one of the leading candidates. It began Phase I clinical trials in humans in March, and was the first vaccine against COVID‑19 in the world to begin Phase II clinical trials.

Under this agreement, CanSino was to provide candidate vaccine doses for Phase I and II clinical trials and grant the NRC a non‑exclusive right to use, produce, and reproduce the vaccine for Emergency Pandemic Use. The IP related to the vaccine candidate was owned by CanSino. As part of the collaboration agreement, the NRC would have been granted a non‑exclusive license to CanSino's IP for manufacturing the vaccine for emergency pandemic use. Researchers at Dalhousie University were to conduct Phase I clinical trials of the vaccine candidate.

Q2. What were the objectives of the agreement with CanSino?
  1. Process transfer to the NRC and modification of the manufacturing process.
  2. Conduct Phase 1 clinical trials at Dalhousie University.
  3. NRC obtaining a licence to produce the Ad5‑nCoV vaccine candidate at no cost for emergency pandemic use for a maximum period of 10 years. There was no charge to the NRC for the production licence.
Q3. What were the benefits to CanSino?

The NRC has proven expertise in the cell line production platform, and by collaborating with the NRC, CanSino was expanding the evaluation and production processes for its vaccine candidate.

A collaboration with Canada would also have been the first potential validation of CanSino's technology internationally. An authorisation from Health Canada has global stature that would have strengthened the reputation of this vaccine candidate.

In addition, Canadian clinical trials would have expanded on data and provided an enhanced understanding of the vaccine candidate's safety profile. These trials would have been done under the authority and review of Health Canada, applying rigorous safety and efficacy standards to pave the way for future regulatory approval in Canada.

Q4. What is the NRC's historical relationship with CanSino?

The NRC's original relationship with CanSino was initiated under the umbrella of the 2007 Canada‑China Agreement for Scientific and Technological Cooperation between the Government of Canada and China.

The NRC's first research collaboration with CanSino was in 2013 on the development of a cell culture process to produce a vaccine against tuberculosis. CanSino then licensed NRC's proprietary cell line in 2014, which they have since used to produce vaccines for other diseases, including Ebola.

Q5. Were there other partners involved?

The Canadian Center for Vaccinology (at Dalhousie University) was engaged to lead the planned clinical trials of Ad5‑nCoV.

Q6. How much has been spent on this collaboration?

The NRC has spent approximately $650K on this project.

Q7. Who received this funding?

Approximately $250K in funding was provided to Dalhousie University's Canadian Center for Vaccinology in order to establish appropriate protocols and obtain approvals for the Clinical Trial Application (CTA) for this specific project. Although the project is not proceeding, the clinical team will be able to apply what they've learned to protocols for future vaccine candidates.

The remaining funds (approx. $400K) were spent by the NRC to purchase research supplies and consumables in support of this research collaboration. A large part of the material obtained with these funds will be available to support other projects.

Neither CanSino nor the Chinese government received any funding from the Government of Canada for this collaboration.

Q8. What were the IP/ Security considerations and mitigation measures undertaken?

The IP related to the vaccine candidate was owned by CanSino. As part of the collaboration agreement, the NRC would have been granted a non‑exclusive license to CanSino's IP for manufacturing the vaccine for emergency pandemic use.

As part of its due diligence with this collaboration agreement, the NRC engaged in ongoing discussions with the Government of Canada's lead security agencies to assess possible risks, beginning in March 2020 (prior to entering the agreement) until August 2020 when the opportunity to conduct clinical trials with this vaccine candidate in Canada had passed.

While the specific content and recommendations of these conversations cannot be released due to security reasons, the security agencies supported the NRC in pursuing this collaboration. To mitigate identified risks, the NRC undertook steps recommended by security agencies and NRC staff participated in briefings on risks and security protocols.

Q9. There is world criticism of how China handled the pandemic. Why work with them on a vaccine?

The ongoing COVID‑19 pandemic is global in nature, and therefore calls for a global response. The NRC is working with international collaborators, as well as domestic partners in industry and across government, to ensure a coordinated approach that will deliver solutions in the most effective and timely manner possible. This is consistent with the public statement of the World Health Organization calling for unprecedented cooperation, collaboration and data sharing to advance research, such that a vaccine suitable for all can be rapidly developed.

CanSino was also the first vaccine developer in the world to publish its peer‑reviewed scientific data regarding the progress of its vaccine candidate, and at the time of the agreement, was among the most advanced vaccine candidates in the world, having already started Phase II clinical trials.

Further, the NRC previously collaborated with CanSino on the development of a vaccine against tuberculosis which made use of the NRC's proprietary cell line. This previous collaboration meant that the NRC was very familiar with the general production process, making the planned technology transfer substantially easier and faster.

Q10. Who signed off on this collaboration?

This collaborative research agreement was signed by the NRC within our authorities.

Q11. What led to the cancellation of this collaboration?

Due to lengthy delays in the shipment of the vaccine doses to Canada, and the fact that CanSino's candidate had already entered advanced testing in other countries, the opportunity to conduct clinical trials in Canada for Ad5‑nCoV had passed and the government decided to focus on more promising candidates.

Q12. How did we brief out? To whom and when?

Prior to entering in this agreement, the NRC advised ISED, the office of the Minister of Innovation, Science and Industry, and other Parliamentarians (all in April 2020).

Q13. What was the timeline?
Table 2

Date

CanSino

Other Vaccines and Therapeutics

2013
  • The NRC and CanSino collaborated on the development of a cell culture process for the production of a vaccine against tuberculosis.
 
2014
  • The NRC’s proprietary HEK 293-SF-3F6 cell line was licensed to CanSino on a non‑exclusive basis.
 
2017‑2018
  • The Chinese Academy of Military Medical Sciences' Bioengineering Institute and CanSino Biologics Inc. created a new Ebola vaccine, referred to as Ad5‑EBOV, using The NRC’s proprietary HEK 293-SF-3F6 cell line.
 
2020 February
  • Feb 11‑12: Initial discussions between NRC and CanSino at WHO meeting in Geneva
 
March
  • Collaboration discussions
    continue
  • Mar 26: NRC and CanSino sign
    Non‑Disclosure Agreement
    (NDA) and begin sharing data.
  • Mar 26: NRC engages the
    Canadian Centre for
    Vaccinology to design clinical trial application to HC
  • Mar 23: federal funding
    announced for AbCellera
    (treatment development),
    Medicago (vaccine development
    and production capacity), VIDOInterVac (enhanced
    manufacturing facility for vaccine
    production), and the NRC
    (biomanufacturing capacity)
April
  • Apr 1: NRC and CanSino sign Material Transfer Agreement to bring CanSino material to Canada
  • Negotiations on Collaborative Research Agreement (CRA) continue
  • NRC undertakes due diligence with OGDs
  • Apr 23: federal funding announced for VIDO-InterVac (vaccine development), the Canadian Immunization Research Network (CIRN, vaccine related research and clinical trials) and the NRC (biomanufacturing capacity)
May
  • May 7: NRC and CanSino sign CRA
  • May 12: NRC announces its plans to work with CanSino
  • May 15: CanSino receives approval of its clinical trial application from HC
  • May 20: scheduled date of shipment from China
  • Late May: efforts from both Canada and China to facilitate shipment
  • Late May: Government becomes aware of delays in the shipment
  • May 3: federal funding announced for AbCellera (antibody therapy development and production facility)
June
  • Mid‑June: shipment returned to CanSino (from airport)
  • Late June: China establishes process for international shipment of vaccine candidates
  • June 16: first meeting of VTF
  • June 29: VTF letter to Ministers recommending domestic collaborations to pursue, including [REDACTED] VBI Vaccines and Medicago
  • June 30: VTF letter recommending additional international candidates, including Sanofi, AstraZeneca, and to [REDACTED]
July
  • July 6: Initial media reports about delays by China's customs agency
  • Ongoing work at NRC to prepare Royalmount facility for clinical trial production
  • NRC evaluated and improved the manufacturing process to facilitate scale up to larger volume production
  • July 5: VTF letter with additional recommendations, including Moderna and Pfizer
  • July 27: VTF letter advising [REDACTED]
August
  • Aug 26: NRC President announces decision to abandon opportunity
  • Aug 5: announcement of Moderna and Pfizer procurement agreements
  • Aug 5: announcement of federal funding for Variation Biotechnologies Inc (VBI, vaccine development and clinical trials)
  • Aug 31: announcement of Johnson & Johnson and Novavax procurement agreements
September  
  • Sep 22: announcement of Sanofi/GSX procurement agreement
  • Sep 25: announcement of AstroZeneca procurement agreement
  • Sep 22‑30: approval of NRC‑IRAP funding to Entos Pharmaceutical, Symvivo Corporation, Biodextris Inc, Pharma Glycovax Inc, Providence Therapeutics
October  
  • Oct 4: approval of NRC‑IRAP funding to ImmunoVaccine Technologies Inc
  • Oct 23: announcement of federal funding for Medicago (vaccine development, clinical trials and manufacturing capacity) and Precision NanoSystems Inc (PNI, vaccine development and clinical trials)