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An Update On The HIV Vaccine Manufacturing Facility

February 19, 2010

The Canadian HIV Vaccine Initiative (CHVI) was established in 2007 to help accelerate global efforts to develop a safe, effective, affordable and globally accessible HIV vaccine. 

Since 2007, the CHVI has endeavoured to address critical gaps identified in the Global HIV Vaccine Enterprise’s Scientific Strategic Plan (SSP) published in 2005, by supporting leading edge discovery and social research, building strong working relationships with international partners and increasing engagement of local communities in this important work.

One of the gaps identified in 2005 was a lack of pilot-scale manufacturing to produce HIV vaccines for clinical trials in North America. As a result, the CHVI committed to dedicate significant funding for the establishment of a pilot-scale manufacturing facility in Canada with additional funds committed from the Bill & Melinda Gates Foundation.

In April 2008, the Government of Canada and the Gates Foundation invited applications from not-for-profit corporations to establish a pilot-scale manufacturing facility in Canada.

A thorough, evidence-based review of all applications was completed. This included an internal review and external review by an international expert panel. None of the applicants were found to be successful in meeting the pre-established criteria.

As part of the due diligence process, a study commissioned by the Gates Foundation to analyse current vaccine manufacturing capacity concluded that there is currently sufficient vaccine manufacturing capacity in North America and Europe to meet research needs. This is good news for the HIV vaccine field. This report is available upon request to the CHVI Secretariat.

After weighing all of the evidence, the Government of Canada and the Gates Foundation have decided not to proceed with the pilot-scale vaccine manufacturing facility. Other CHVI programs are unaffected by this decision and will continue to move forward.

As with any initiative, we need to ensure that proposals meet application criteria and represent value for money for our respective organizations, as well as Canadian taxpayers. Capacity for scientific research is evolving globally and the Government of Canada must invest its resources where they will be most effective in the fight against HIV/AIDS.

Moving forward, the Government of Canada and the Gates Foundation will continue to work together to fund HIV prevention and remain committed to the previously announced funding levels over five years - up to $111 million from the Government of Canada and up to $28 million from the Bill & Melinda Gates Foundation.  Both parties remain committed to accelerating the development of safe, effective, accessible and affordable HIV vaccines, as one of our key priorities.

Given the importance of our objectives, we are examining all options and will take the time needed to ensure that the direction we take and the activities we choose to support yield the best possible results. Further details will be provided once the areas of investment have been further defined.


 

Consultation on Canadian HIV Vaccine Initiative (CHVI) Funding Programs
(February 10-12, 2008) - Summary

On February 10-12, 2008, CHVI participating departments and agencies (Canadian International Development Agency, Public Health Agency of Canada, Industry Canada, Canadian Institutes of Health Research, and Health Canada), hosted a consultation on funding programs in Ottawa.

The objective of the Consultation was primarily to seek input on three new CHVI funding programs focussing on discovery and social research; clinical trials capacity building and networks; and policy development and community engagement. As well, the consultation provided opportunities for cross-sectoral networking and information-sharing on the CHVI.

A broad spectrum of domestic and international stakeholders attended the meeting, including representatives from Canadian and international research institutions, non-governmental organizations, the private sector, provincial and territorial governments, participating departments/agencies and other federal departments.

Participant List

A key component of the meeting comprised presentations on

  • Global HIV Vaccine Enterprise
  • Canadian HIV Vaccine Initiative
  • Global HIV Landscape


This was followed by intensive discussions where participants contributed expert advice on priorities and areas of focus.

The results of discussions at the Consultation will be used to inform the development of the Request for Proposals/Application. A final report of the meeting was published. In addition, ongoing committees; information-sharing fora and other mechanisms for the CHVI will be established.

Discovery and Social Research

Release of Discovery and Social Research Catalyst Grants

The first of the CHVI discovery and social research (DSR) funding opportunities, the Operating Grants were launched in June 2008 by CIHR.  The second of the DSR funding opportunities, the Catalyst Grants New Window, launched in August 2008 by CIHR, are intended as short-term seed money to support Canadian researchers involved in innovative HIV vaccines-related research activities.

Funding Opportunities - Archive

Discovery and Social Research

  • Release of Discovery and Social Research Operating Grants - CLOSED
  • Funding Opportunity Announcement Discovery and Social Research Operating Grants - CLOSED
  • Release of Discovery and Social Research Catalyst Grants - CLOSED

Application Form  CALL CLOSED

Community Initiatives Fund

pilot-scale Manufacturing Capacity for HIV Vaccine Clinical Trial Lots

Policy and Regulatory Issues, Community and Social Dimensions

FUNDING OPPORTUNITY ANNOUNCEMENT
Letter of Intent (LOI) CALL CLOSED

Pilot-scale HIV Vaccine Manufacturing Facility in Canada for Clinical Trial Lots

Deadline for Submissions: June10, 2008 at 4:00 PM EDT

Under the CHVI, the Government of Canada (specifically the Canadian International Development Agency, the Public Health Agency of Canada and Industry Canada) and the Bill & Melinda Gates Foundation have made it a priority to fund the establishment of a pilot-scale manufacturing facility in Canada to increase the global capacity to produce HIV vaccine candidates for use in clinical trials.

This LOI Form is the first stage in the application process for funding for the Pilot-scale HIV Vaccine Manufacturing Facility in Canada for Clinical Trial Lot. Based on the strength of the LOI, selected applicants will be invited to complete and submit a full Application Form which will be due in late October 2008.

Prior to completing the LOI Form, please ensure you have reviewed the Invitation to Submit Applications (355 KB .pdf) New Window document which describes in detail the objectives of this project as well as the two stage process to apply document.

Eligibility

To be eligible for funding, Applicants must meet the following:

  • be a Not-for-Profit Corporation (NPC) incorporated under appropriate legislation, or act of
    parliament or foreign equivalent for non-Canadian corporations;
  • have structure, governance and funding arrangements that allow objective execution of its
    not-for-profit mandate;
  • are competent, credible and accountable in carrying out activities;
  • are guided by objectives and principles consistent with CHVI objectives;
  • have an elected, voluntary Board of Directors; and
  • bear a portion of the costs associated with this initiative, particularly for its ongoing operations, through the contribution of its own funds and/or the contribution of funds and/or in-kind contributions to the facility that it attracts from others.

A university, post-secondary college or educational institution is considered eligible if it has its own board of directors.

The geographic location of the Applicant’s headquarters will not be restricted although the location of the facility must be in Canada. While the NPC is not required to be headquartered in Canada, it should have a presence in Canada.

For-profit organizations and not-for-profit organizations that are agencies of government will not be eligible for funding. However, it is expected that the Applicant will partner with for-profit and other organizations and/or individuals to access the necessary expertise and resources for this project.

An applicant that is not certain whether it is eligible should reach the contact person named in the Notes to Applicants section for assistance in determining its eligibility. The contact person may request additional information to make a determination.

How much funding is available?

The maximum amount of funding available for this project is $88M.

Submission Deadline and Requirements:

All LOIs must be submitted in hardcopy by June 10, 2008 at 4:00PM EDT to the contact person identified below. Please refer to section “Notes to Applicants” of the LOI Form for additional requirements.

Contact Information:

Any questions or requests for clarification regarding this funding opportunity must be submitted via email to secretariat@chvi-icvv.gc.ca. All questions and requests along with the associated responses will be posted anonymously on the CHVI Web site page within five (5) calendar days of receiving the question/request. Only questions and/or requests submitted up to seven days before the deadline for the LOI Form will be answered. Applicants are encouraged to check the Q&A Section of the CHVI Web site daily to keep up-to-date with any posted questions, answers and corrections.


Canadian HIV Vaccine Initiative Secretariat
c/o Office of HIV Vaccines
Public Health Agency of Canada
200 Eglantine Driveway
8th Floor, Jeanne Mance Building
AL 1908 B
Ottawa, Ontario Canada
K1A 0K9
Telephone: 613-952-5120
Facsmile: 613-946-7528

E-mail Address: secretariat@chvi-icvv.gc.ca