Senate Committee Testimony on the HIV Vaccine

Introduction
Good morning and thank you, Madam Chair, and members of the Committee. I am Dr. Stefano Bertozzi, director of HIV programs at the Bill & Melinda Gates Foundation. It is a pleasure to be with you today.

I joined the Gates Foundation eight months ago, and was previously with the National Institute of Public Health in Mexico. Prior to that, I worked for UNAIDS, the World Health Organization’s Global AIDS Programme, and the World Bank.

Canada’s Leadership on Global Health
I would like to start by acknowledging and thanking Canada for its leadership on global health and development issues, including HIV/AIDS. Canada’s efforts to improve lives in developing countries are having an extraordinary impact.

The Gates Foundation is pleased to have strong relationships with Canada. We co-fund several global partnerships in health and development with Canada. We have provided a number of major grants to Canadian organizations – for example, the University of Manitoba – for work on AIDS and other global health issues.

We are also pleased that Canada intends to make the health of women and children in the developing world a focus of this year’s G8 meeting.

About the Gates Foundation
Let me take a moment to discuss the Gates Foundation’s global health strategy, including our support for HIV vaccine research and development. Bill and Melinda Gates established the foundation to help people throughout the world live healthy, productive lives. Global health is our largest giving area, and we focus on harnessing advances in science and technology to reduce illness and death in developing countries. Our number-one priority is the development and delivery of vaccines for infectious diseases. An HIV vaccine in particular is a top personal priority for Mr. and Mrs. Gates.

About Our HIV Vaccine Partnership
An HIV vaccine is undoubtedly one of the most urgent priorities in global health today. It is also one of the most difficult. Due to the dynamic nature of the science, we must stay flexible in the face of new knowledge. This includes the potential to make changes to existing strategies or directions in order to take advantage of new science and maximize existing resources.

As you know, in 2007, the Canadian Government and the Gates Foundation announced a partnership to accelerate HIV vaccine research and development. The vision for the partnership is to address critical research needs identified by the Global HIV Vaccine Enterprise, an international alliance of HIV researchers, funders, and advocates. The partnership, which is managed by the Canadian HIV Vaccine Initiative, or CHVI, included a pledge of up to CAN$ 111 million in funding from Canada, and up to CAN$ 28 million from the Gates Foundation. The Gates Foundation strongly values our HIV vaccine partnership with Canada and remains committed to our funding pledge.

Call for Proposals on Manufacturing
In 2007, when the HIV vaccine partnership was announced, one of six priorities identified by the Global HIV Vaccine Enterprise was expanding global capacity to manufacture HIV vaccines for clinical trials. In response, the Canadian HIV Vaccine Initiative issued a call for proposals to build an HIV vaccine manufacturing facility for production of pilot lots, and four applicants were ultimately invited to submit full proposals.

In the meantime, two important pieces of new information became available. We felt it was our responsibility to respond accordingly.

First, the landscape of HIV vaccine science changed dramatically. When Prime Minister Harper and Mr. Gates announced the partnership in Ottawa in February 2007, a potentially promising HIV vaccine candidate was in the advanced stages of human testing. Many experts believed this vaccine would show at least partial effectiveness, and pave the way for additional trials to improve it, thus requiring manufacturing of additional candidate vaccines for testing in humans. But the vaccine was later found to be ineffective.

In the wake of these disappointing results, clinical trials of related HIV vaccines were halted. Prominent researchers called for a return to basic research to discover new vaccine candidates, and for better ways to identify which vaccines are truly promising.

The second piece of new information came from an independent analysis of global vaccine manufacturing capacity, which the Gates Foundation commissioned in 2009. That analysis found that there had been a significant increase in vaccine manufacturing capacity in North America and Europe since the Global HIV Vaccine Enterprise issued its guidance in 2005, and in fact there was no longer a need for a new facility.

Decision to Change Course
The foundation shared these findings with our Canadian counterparts, and we jointly decided that a new manufacturing facility should no longer be an immediate focus of the partnership.

As I believe you have already heard, we received the results of the manufacturing capacity study at the same time that independent, external reviewers of the facility proposals determined that none met the full criteria. Given the findings of the capacity study, it did not make sense to ask for new or modified proposals.

We recognize and sincerely thank the applicants who put substantial time and resources into preparing proposals. However, from the perspective of the Gates Foundation, this was the right decision. It is our mandate to direct resources to where they can have the greatest impact, and we must be willing to change course based on new data. I would like to emphasize that we, together with our Canadian counterparts, did not take this decision lightly.

Looking Forward
There is still a bright future for HIV vaccine research, but the trajectory is likely to be different than what was anticipated a few years ago. Recent results from the RV144 trial conducted in Thailand have provided renewed reasons for optimism.

As I mentioned at the outset, the Gates Foundation remains strongly committed to both HIV vaccines and the partnership with Canada. At the Gates Foundation, our number-one HIV priority is acceleration of HIV vaccine development for Africa. We are in close discussions with our Canadian colleagues about funding priorities moving forward with a clear focus on accelerating the development of an HIV vaccine.

The foundation will fulfill our funding pledge to our HIV vaccine partnership, and we are pleased that Canada has said it will do the same. It is important to note that from the outset, our understanding has been that Canadian funds for this vaccine partnership will constitute new resources, and will not take away from prior government spending on AIDS.

Closing
Thank you again for the opportunity to speak with you today. Canada’s leadership on science and global health – which spans all parties and political affiliations – is of the utmost importance. I look forward to your questions.