HESA Committee Report
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COMMITTEE ON HEALTH: Review of the Cancellation of the Canadian HIV Vaccine Initiative’s HIV Vaccine Manufacturing Facility Project PREAMBLE Canada is a world leader in HIV and vaccine research and development, and the Canadian HIV Vaccine Initiative (CHVI) drives that leadership forward. Through the CHVI, the Government of Canada in collaboration with the Bill & Melinda Gates Foundation is investing up to $139 million to accelerate development of a safe, effective, affordable and globally accessible HIV vaccine. The CHVI is a horizontal initiative involving the Public Health Agency of Canada, the Canadian International Development Agency, Health Canada, the Canadian Institutes of Health Research and Industry Canada. It also supports the Global HIV Vaccine Enterprise’s Scientific Strategic Plan. THE RENEWED CANADIAN HIV VACCINE INITIATIVE The CHVI highlights our country’s world-class HIV and vaccine research expertise. In July 2010, the Minister of Health announced the renewed CHVI in collaboration with the Bill & Melinda Gates Foundation. The CHVI Research and Development Alliance is the cornerstone of the renewed CHVI, and will enable Canada to be a leading contributor to global efforts in developing a safe, effective, affordable and globally accessible HIV vaccine. The Alliance is a network of public and private sector organizations with expertise in HIV/AIDS and vaccines fields. The Alliance will serve as the focal point for Canadian research, product development and technical expertise related to HIV vaccines. The Alliance will work with partners in low- and middle-income countries, particularly in Africa, to leverage local expertise and knowledge, build on cooperative research and policy initiatives, and expand needed local capacity. The Alliance will:
The key areas of focus for the Alliance will be:
The Alliance is unique in that its broad membership will allow it to see where the gaps exist, and direct investments accordingly. The Government of Canada’s investment in the CHVI Research and Development Alliance complements our efforts to address the spread of HIV and AIDS in Canada. The Alliance is advancing the science that will lead us towards the ultimate goal of an HIV vaccine. Another important component of the renewed CHVI is the Government of Canada’s investments, through the Canadian International Development Agency (CIDA), in the prevention of mother-to-child transmission of HIV in low- and middle-income countries. As the development of an HIV vaccine will take time, these investments will support global HIV prevention to reduce global HIV infection rates. Following the July 2010 announcement, the Government of Canada consulted with HIV/AIDS community organizations, academic researchers, Government researchers and the private sector to seek their input on the implementation of the Alliance. The consultation process included web-based consultations, a face-to-face meeting and one-on-one interviews. The purpose of the consultation was to gather input from key stakeholders on: informing how to best implement the Alliance and the Alliance Coordinating Office; the draft Invitation to Submit Applications for the Alliance Coordinating Office; and determining how the Alliance can best contribute to achieving the priorities of the Global HIV Vaccine Enterprise’s 2010 Scientific Strategic Plan. The consultation process provided rich information to inform ways forward in the successful establishment of the new Alliance and the Alliance Coordinating Office. Many participants in the process also expressed considerable appreciation for having been consulted and saw this as an important first step in building interest in the new Alliance and future collaboration and engagement. Input from the consultation will be considered in moving forward with the establishment of the Alliance and specific input received on the Invitation to Submit Applications to establish the Alliance Coordinating Office was used to revise the Invitation to Submit Applications. On December 1, 2010 the Government of Canada marked World AIDS Day by launching the Invitation to Submit Applications for the Alliance Coordinating Office, with a deadline for applications of February 15, 2011, and appointing, in collaboration with the Bill & Melinda Gates Foundation, Dr. Bhagirath Singh and Dr. Jose Esparza, as Co-chairs, of the CHVI Advisory Board. Biographies of the Co-chairs are found at the end of this document. PROGRESS ON CHVI ACTIVITIES (2007-2010) Over the last three years, a number of CHVI activities have been implemented and important progress has been made towards the development of a safe and effective HIV vaccine. Since 2007, funding has been provided to support over thirty projects, including the following:
CHANGE IN DIRECTION The CHVI was originally launched in 2007 and its initial cornerstone was the establishment in Canada of a pilot scale HIV vaccine manufacturing facility to produce clinical trial lots. The facility was intended to address the global shortage in pilot scale manufacturing identified in the Scientific Strategic Plan. The Government of Canada and the Bill & Melinda Gates Foundation committed a total of approximately $88 million (Government of Canada - $60 million; Bill & Melinda Gates Foundation - $28 million) towards this component of the CHVI. Consultations were held in late 2007, by the Government of Canada and the Bill & Melinda Gates Foundation, to seek expert input on how to move forward with establishing a facility in Canada. Based on this consultation, a process was launched in April 2008 to select a not-for-profit corporation to build, operate and manage the facility. Full applications were received in March 2009 from not-for-profit organizations, and a thorough and comprehensive review process was undertaken. The criteria to be assessed in the review were shared with all applicants at the outset of the process. Key international experts participated in the external review, assessing the strengths and weaknesses and the scientific merit of each application. These experts were highly qualified in the areas of HIV vaccine research, facility construction and operations, and governance and financial management. This was complemented by an internal review by the Government of Canada and the Bill & Melinda Gates Foundation officials that assessed issues of financial self-sustainability, administrative capacity, value-for-money and applicant risk. Overall, the review process found that although all the applications had some strengths, none of them met all of the pre-established criteria. Applicants were notified in January 2010 that their applications were not approved for funding and were provided with summaries of their technical assessments. More importantly, however, the vaccine landscape changed. A study commissioned by the Bill & Melinda Gates Foundation and made available to the Government of Canada in July 2009, concluded that there is currently sufficient manufacturing capacity available to support the anticipated demand for pilot scale manufacturing for candidate HIV vaccines. This is why following careful consideration and discussions the Government of Canada and the Bill & Melinda Gates Foundation decided not to proceed with providing funding for the pilot scale HIV vaccine manufacturing facility and agreed to continue collaborating and exploring new opportunities. REPORT OF THE STANDING COMMITTEE ON HEALTH In March 2010, the House of Commons Standing Committee on Health passed a motion to conduct a review of the Government of Canada’s decision to cancel the establishment of the Pilot Scale HIV Vaccine Manufacturing Facility in Canada that would be used for the production of HIV vaccines for clinical trials in Canada. On October 7, 2010 the Standing Committee on Health published its report. Overall the renewed CHVI aligns with the recommendations provided by the Committee. The following outlines the Standing Committee’s recommendations and the Government’s response to these recommendations. Recommendation 1: Where feasible, that the Government of Canada conduct future Canadian HIV Vaccine Initiative grant competitions through arms length federal research agencies, such as the Canadian Institutes of Health Research, or the Canadian Foundation for Innovation, which may allow for increased interaction between applicants and the granting agency during the application process. Response: Since 2007, CHVI funding has been provided through the Canadian Institutes of Health Research and the Global Health Research Initiative to support twenty-eight research grants that, for example, support:
As a CHVI participating agency, Canadian Institutes of Health Research will continue to oversee award of grant funding in the area of Advancing Basic Science of HIV Vaccines, with the overall objective of strengthening the capacity and promoting greater involvement and collaboration among researchers in HIV vaccine discovery and social research in Canada and in low- and middle-income countries. Moving forward with advice from the CHVI Advisory Board, the appropriate funding mechanisms, including the frequency of interaction with applicants, will be identified to implement new activities. Activities undertaken by the Canadian Institutes of Health Research will:
Activities will also be undertaken by the Canadian HIV Technology Development component of the National Research Council's Industrial Research Assistance Program that will:
Recommendation 2: That the Government of Canada and the Bill & Melinda Gates Foundation take into consideration the following priorities identified by HIV researchers, as possible areas in which to allocate funding from the Canadian HIV Vaccine Initiative: immunology related HIV research; team grants for HIV researchers; anti-viral drugs; and the pre-purchasing of vaccine production capacity for HIV vaccine candidates put forth by HIV researchers. Response: With respect to the specific areas identified in this recommendation, the Government agrees that the CHVI should support immunology-related research, team grants for researchers and the production of HIV vaccine candidates put forth by HIV researchers. To date funding has been provided to the following initiatives:
Moving forward, these types of research activities will continue to be funded under the renewed CHVI including those that:
CHVI funding will not support the production of anti-viral drugs, as it is outside the scope of the collaboration between the Government of Canada and the Bill & Melinda Gates Foundation. However, HIV vaccine research and development activities can, when appropriate, build on synergies created by work on new HIV prevention technologies, including that of highly active anti-retroviral therapy. As well, the CHVI’s regulatory capacity work will be beneficial for the development of other vaccines and new therapies. Recommendation 3: Where feasible, that the Government of Canada conduct independent needs assessments in relation to projects funded under the CHVI. Response: As part of the due diligence process, the CHVI departments/agencies will continue to conduct independent needs assessments and consult with stakeholders, as appropriate. All HIV vaccine-related project proposals will be subject to formalized reviews by CHVI departments/agencies and the Bill & Melinda Gates Foundation (including peer review) and be based on international standards of research excellence, as appropriate. Prevention of mother-to-child transmission of HIV proposals will be generated and reviewed by the Canadian International Development Agency. All funding decisions will be made by CHVI Ministers, informed by recommendations made by the CHVI Advisory Board. Furthermore, the Advisory Board will strive to ensure coherence with ongoing and new CHVI activities, Government of Canada and the Bill & Melinda Gates Foundation HIV/AIDS strategies and the Global HIV Vaccine Enterprise’s Scientific Strategic Plan, as appropriate. CONCLUSION: The Government of Canada and Bill & Melinda Gates Foundation are committed to accelerating the development of a safe, effective, affordable and globally accessible HIV vaccine. The Canadian HIV Vaccine Initiative Research and Development Alliance will build a network in Canada of some of the brightest minds to advance important national and international research and development initiatives in a coordinated manner every step of the way. The Alliance will build on the momentum from last year’s promising clinical trial results in Thailand and on the significant progress of CHVI activities underway to date. It will help Canadian and international researchers access the resources required to do the work that is needed to get an HIV vaccine approved for use. The shift from establishing a pilot-scale manufacturing facility to launching the CHVI Research and Development Alliance was based on the latest research regarding the HIV vaccine landscape and represents the best investment. Through this important investment and Alliance, our Government is ensuring that Canada continues to lead the way in the global fight against HIV and AIDS. THE RENEWED CANADIAN HIV VACCINE INITIATIVE In July 2010, the Minister of Health, in collaboration with the Bill & Melinda Gates Foundation, announced the renewal of their commitment of $139 million to implement the Canadian HIV Vaccine Initiative (CHVI). The federal government departments and agencies that continue to participate in the CHVI are the Canadian International Development Agency the Public Health Agency of Canada, Industry Canada, the Canadian Institutes of Health Research and Health Canada. The Minister of International Cooperation, the Minister of Health, and the Minister of Industry collaborate on the implementation of the CHVI, with the Minister of Health as the lead Minister for the CHVI. The primary goal of the renewed collaboration is to accelerate the development of a safe and effective HIV vaccine by building on Canada's scientific excellence for the benefit of those most in need in Canada and in low- and middle-income countries (particularly in Africa). The renewed CHVI includes activities in the following areas:
The renewed CHVI features the creation of the CHVI Research and Development Alliance (Alliance). The Alliance will enable Canada to be a leading contributor to global efforts in developing a safe, effective, affordable and globally accessible HIV vaccine. The Alliance will:
The Alliance will be supported by a coordinating office (Alliance Coordinating Office), which will focus on building and sustaining the Alliance, advise the Government of Canada and the Bill & Melinda Gates Foundation on research gaps, prospect innovative proposals to respond to identified gaps, and promote synergy between Alliance members. The Alliance Coordinating Office will be selected via an open solicitation, led by the Public Health Agency. An Advisory Board will provide governance and oversight over the renewed CHVI. The Advisory Board is comprised of up to three representatives from the Bill & Melinda Gates Foundation, the Director of the Alliance Coordinating Office and three external experts and one (non-voting) representative from each of the CHVI departments/agencies. Advisory Board experts have been appointed by CHVI Ministers and are drawn from a range of business, scientific and international development sectors to provide the appropriate advice to the CHVI Ministers and the Bill & Melinda Gates Foundation. The Advisory Board will provide advice on implementation and make recommendations on funding for projects to Ministers of Health, Industry and International Cooperation, and to the Bill & Melinda Gates Foundation. CHVI RESEARCH AND DEVELOPMENT ALLIANCE - CONSULTATION FINDINGS Following the July 2010 announcement, the Government of Canada consulted with HIV/AIDS community organizations, academic researchers, Government researchers and the private sector to seek their input on the implementation of the Alliance. The consultation process included web-based consultations, a face-to-face meeting and one-on-one interviews. The purpose of the consultation was to gather input from key stakeholders on: informing how to best implement the Alliance and the Alliance Coordinating Office; the draft Invitation to Submit Applications for the Alliance Coordinating Office; and determining how the Alliance can best contribute to achieving the priorities of the Global HIV Vaccine Enterprise’s 2010 Scientific Strategic Plan. The participants identified a number of factors key to the successful implementation of the Alliance. Four main themes emerged which included:
Stakeholders also indicated that targeted outreach was considered important to ensure that the right players are engaged in the Alliance, and additional incentives may be needed such as financial rewards and special recognition for particular contributions. In addition, scientific credibility and leadership in the network was identified as important for engagement of the research community. Finally, consultation participants noted that offering a range of mechanisms for engagement such as face-to-face knowledge sharing opportunities would also be of value. Stakeholders were consulted on key factors that would contribute to the Alliance achieving its mandate, and guiding principles for the Alliance Coordinating Office, key factors include:
Consultation participants identified the need to clarify the goals of the Alliance and the Alliance Coordinating Offices’s governance and decision-making accountability. Three prospective roles were suggested including: brokering of relationships and collaborations; leveraging funds and partnerships; marketing and communicating in order to engage multiple stakeholders and to assume an educational role on the global stage; and, possibly the coordination of strategic orientations of the Alliance. The consultation process provided rich information to inform ways forward in the successful establishment of the new Alliance and the Alliance Coordinating Office. Many participants in the process also expressed considerable appreciation for having been consulted and saw this as an important first step in building interest in the new Alliance and future collaboration and engagement. Input from the consultation will be considered in moving forward with the establishment of the Alliance and specific input received on the Invitation to Submit Applications to establish the Alliance Coordinating Office was used to revise the Invitation to Submit Applications. On December 1, 2010 the Government of Canada marked World AIDS Day by launching the Invitation to Submit Applications for the Alliance Coordinating Office, with a deadline for applications of February 15, 2011, and appointing, in collaboration with the Bill & Melinda Gates Foundation, Dr. Bhagirath Singh and Dr. Jose Esparza, as Co-chairs, of the CHVI Advisory Board. Biographies of the Co-chairs are presented below. CHVI ADVISORY BOARD CO-CHAIRS Dr. Bhagirath Singh Dr. Bhagirath Singh received his post-doctoral training at Liverpool University in England, and in 1973 joined the Department of Immunology at the University of Alberta in Edmonton, Alberta. He became Professor of immunology in 1986. In 1992, he moved to The University of Western Ontario in London, Ontario, as Professor and Chair of the Department of Microbiology and Immunology (1992-2000). Dr. Singh has been scientific director of the Institute of Infection and Immunity (III) since its inception. He has also served as deputy director of The John P. Robarts Research Institute (1997-2000) and co-director of the Immunology Program (1992-1997). Dr. Singh has been co-director and principal investigator in both the MRC/CIHR Juvenile Diabetes Research Foundation group in diabetes research, and the MRC immunoregulation group. Dr. Singh has received scholarship and scientist awards from the Alberta Heritage Foundation for Medical Research. In 2004, he became a Fellow of the Royal Society of Canada. Dr. Singh's laboratory has established a strong record of research in molecular and cellular immunology, and in the role of microbial pathogens in the regulation of autoimmune diseases such as juvenile diabetes. He is recognized as a leader in the fields of the immunology of peptides and the regulation of autoimmune diseases. In addition to being the Scientific Director of III, Dr. Singh is currently Professor in the Department of Microbiology and Immunology at The University of Western Ontario, and a scientist at the Robarts Research Institute. José Esparza MD, PhD Senior Advisor Global Health, HIV Since 2004 he has been the Senior Adviser on HIV Vaccines at the Global Health Program of the Bill & Melinda Gates Foundation, in Seattle, WA, USA, where he helped launching the Collaboration for AIDS Vaccine Discovery (CAVD). In 1968 he received his MD from Zulia University, in his native country of Venezuela, and immediately started his training in virology at the Venezuelan Institute of Scientific Research (IVIC), in Caracas, Venezuela. In 1974 he received his PhD in Virology and Cell Biology from the Department of Virology and Epidemiology of Baylor College of Medicine in Houston, TX, USA. From 1974 to 1985 he was a Research Scientist at IVIC in Caracas, where he became Full Professor (Investigador Titular), Chief of the Laboratory of Biology of Viruses, and Chairman of the Center of Microbiology and Cell Biology. From 1980 to 1982 he spent a Sabbatical as a Visiting Professor at the Department of Microbiology and Immunology from Duke University, in Durham, NC, USA. In 1986 he joined the World Health Organization in Geneva, Switzerland, where he became Chief of the Biomedical Research Unit of the Global Programme on AIDS (GPA) and then moved to UNAIDS, also in Geneva, where he was the Coordinator of the WHO-UNAIDS HIV Vaccine Initiative. He formally retired from WHO-UNAIDS in December 2005 (on leave to the Gates Foundation since March 2004). Until December 2007 he served as the Head of the Interim Secretariat of the Global HIV Vaccine Enterprise, and he is currently the President of its Board of Directors. He has published over 150 papers, mostly in virology, HIV/AIDS and vaccine development. |