March 31, 2006
Mr. Chairman and members of the subcommittee, I sincerely appreciate the opportunity to submit this testimony in support of the PATH Malaria Vaccine Initiative (MVI). I am requesting, through the US Agency for International Development (USAID), $5 million in FY 2007 funds for vaccine research & development (R&D) being conducted by multiple vaccine development partners and being managed by MVI. I am also requesting that you boost overall FY 2007 spending on malaria, including full support for the President’s Malaria Initiative.
I want to thank you for your commitment and continued support for interventions to protect against malaria. Your efforts to include $100 million in bilateral funding provided last year, language in the Foreign Operations conference report calling for direct support of $3 million for MVI in FY 2006, as well as your funding recommendations for MVI in the previous Foreign Operations appropriations bill, resulted in a multi-year partnership with the USAID’s Program for International Development.
Funding to date—though far short of the $3 million recommended by Congress—has allowed MVI to advance a promising Walter Reed vaccine candidate into a Phase 2 pediatric clinical trial in Kenya. The trial started last year and the results will be available by late 2006.
Support from Congress makes a difference and more support is still needed
I applaud the United States Congress for understanding the urgency of the
malaria crisis and for pledging increased resources for malaria activities
and programs
over the past five years. Our nation’s pledge to help halve malaria
deaths as part of the Millennium Development Goals and to provide funding
through
the Global Fund for AIDS, TB, and Malaria, are definitely praiseworthy steps.
We also support the President’s Malaria Initiative to increase funding of malaria prevention and treatment by more than $1.2 billion over five years. The goal of the initiative is to reduce malaria deaths by 50 percent in three target countries (Angola, Uganda, and Tanzania) after three years of full implementation. This is an extremely important initiative that, when expanded to other highly endemic countries, will yield positive results for Africa as well as the global community.
Most of you are aware that more than one million people who die from malaria every year are sub-Saharan African children. Those who are not killed by the disease often suffer its long-lasting, debilitating effects. Malaria wreaks havoc on societies and economies.
But malaria is both preventable and treatable. New and better tools are needed to end the deaths from the disease, and there are multiple groups, including MVI, that are working to ensure that we have those tools.
Due to the notable progress made on several fronts in recent years, many in the public health community believe malaria can be defeated. Examples of this progress include the implementation of programs to scale up malaria-control interventions to the national level, the introduction of long-lasting, insecticide-treated nets in several endemic countries, and the success of a pediatric malaria vaccine in clinical trials supported by MVI in Mozambique.
The Mozambique results prove that it is absolutely possible to make a malaria vaccine that can have significant public health impact. If the appropriate forces are marshaled, progress against malaria can be accelerated over the next several years.
More resources means more and faster progress
To date, MVI has established 11 vaccine development partnerships and has supported
26 vaccine clinical trials in Africa, Europe, Asia and the United States. Progress
from each project provides valuable data on which concepts work and should
be advanced. As a result, more and improved malaria vaccine candidates are
moving into clinical trials than ever before.
The U.S. Army and the Kenya Medical Research Institute launched a Phase 2 pediatric malaria vaccine trial last year, the results of which will be available in late 2006. If the vaccine proves effective in this trial, it could pave the way for a combination vaccine which could have the higher levels of protection we are all looking for.
Two of the National Institutes of Health’s (NIH) malaria vaccine candidates underwent Phase II clinical evaluation. MVI support also propelled four additional products to the cusp of Phase l clinical evaluation by the end of 2005. Safety and preliminary immunogenicity data from studies evaluating vaccines from NIH, Walter Reed Army Institute of Research, and China’s Wanxing Biopharmaceuticals will be available in late 2006.
Increased funding is needed to continue such progress and further accelerate the development of promising malaria vaccine candidates.
Malaria vaccine: no longer a question of if but when
2005
was a pivotal year for MVI and its partners. The last time I testified before
this committee,
I told you about the results of a landmark malaria vaccine
trial involving GlaxoSmithKline Biologicals’ (GSK) RTS,S vaccine which
offered significant protection against malaria in children 1-4 years old
in Mozambique. After the initial six-month study period, the vaccine underwent
an additional 12-month follow up period. More than 1,400 of the children
involved
in the initial trial were followed for continued assessment of safety, immunogenicity,
and efficacy. RTS,S was shown to reduce clinical malaria episodes by 35 percent
and severe malaria episodes by 49 percent. MVI and its partners will complete
the pediatric development of RTS,S and take the vaccine through licensure
and introduction if successful.
The results of this trial were seen by many as the most significant advance ever in the 50-year quest for a malaria vaccine. The results also demonstrated that it is absolutely possible to make a vaccine that can protect children in Africa against malaria. We must now shift our thinking from whether or not a malaria vaccine is feasible to how soon a vaccine could be available to those who need it most.
At a time when we are poised for even more success, funding is not keeping pace with developments. Recognizing federal budget constraints, MVI would like you to know that funds are being used wisely and that we are continuing to leverage other funds. It is critical that we continue to boost malaria spending to make the most of recent successes.
Evidence proves that a malaria vaccine is possible. The vaccine pipelines are filling, which is good—more candidates mean more likelihood of success, especially if what is learned from them is applied across the field. The paradox is that clinical testing is more expensive than earlier stages of development—and it gets more expensive as the product progresses toward evaluation in field trials. Today, it is truly money more than science that limits the creation of a new tool that could save millions of young lives.
I urge the committee to recommend that at least $5 million be provided in FY 2007 for the vaccine R&D being carried out by MVI. I also encourage the committee to increase overall FY 2007 funding on malaria including increased contributions to the Child Survival and Health account. The message that I want to leave with you today is clear; public dollars invested in malaria vaccine development are paying off. Money invested in this area is yielding concrete results that matter.
Again, thank you very much for the opportunity to present our testimony today.
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