Frequently asked questions about MVI

What is the PATH Malaria Vaccine Initiative?

The PATH Malaria Vaccine Initiative (MVI) is a vaccine development program of PATH, an international nonprofit organization working to improve global health. Established in 1999 and funded primarily by the Bill & Melinda Gates Foundation, MVI works to accelerate the development of malaria vaccines and to ensure their availability and accessibility in the developing world.

Who is PATH?

PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, we help provide appropriate health technologies and vital strategies that change the way people think and act. Our work improves global health and well-being. Learn more: www.path.org.

Why was MVI created?

MVI was created on the premise that, while promising vaccine candidates existed, they required assistance to get out of the laboratory and on a path toward clinical trials. Scientists had long demonstrated that immunizing against malaria was theoretically possible. However, efforts in this direction were hampered by financial hurdles and the technical complexities of developing any vaccine against a parasite such as Plasmodium (P.) falciparum (the most deadly of the malaria parasites).

What does MVI hope to achieve?

Working with partners in private industry, government, and academia, MVI aspires to develop, by 2015, a malaria vaccine with protective efficacy equal to or greater than 30 percent against clinical disease and that lasts longer than one year. The program also aims to develop, by 2025, a vaccine with 80 percent or greater efficacy that lasts up to four years.

What does MVI do?

MVI identifies promising malaria vaccine candidates and facilitates their path from the laboratory to clinical trials. At the same time, MVI works to ensure that the vaccines will be available and accessible where needed.

How will MVI meet its long-term goal of developing a malaria vaccine?

To ensure the development of P. falciparum vaccines with at least 80 percent efficacy against clinical malaria in children through age five and in pregnant women, MVI will:

  • Maintain a vaccine project portfolio with at least eight preclinical projects, at least four early clinical projects, and at least one late clinical project.
  • Complete RTS,S Phase 3 development activities to initial filing go/no-go decision.
  • Ensure all supported clinical evaluations are consistent with international standards.
  • Lead the development and maintenance of evaluation tools to comparatively assess candidate vaccines and better inform development decisions.
  • Consider practical aspects of vaccine supply, approval, and use during advanced clinical development.

To ensure that P. falciparum malaria vaccines are available and affordable where needed, MVI will:

  • Lay the foundation for a competitive market environment for malaria vaccines.
  • Partner with developing country manufacturers to reduce costs.
  • Ensure financing of effective vaccines.
  • Catalyze processes and policies to minimize time between availability and use.

To engage malaria-endemic countries to ensure ownership and leadership in use of the vaccines at levels similar to coverage of other childhood immunizations MVI will:

  • Support efforts to develop regulatory capacity in malaria-endemic countries.
  • Develop a foundation for informed country-level decision-making regarding use of malaria vaccines.
  • Engage communities to accept malaria vaccines.