HHS/FDA and PATH Malaria-Vaccine Initiative Announce Research Collaboration Grant

Will Help Develop Tests to Evaluate Experimental Malaria Vaccines

October 7, 2008 - The Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) has announced a collaboration with the PATH Malaria-Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and activity of experimental malaria vaccines before they enter human clinical trials.

The PATH-MVI collaborative project is expected to span about three years, under the Cooperative Research and Development Agreement (CRADA) program, which allows Federal laboratories and businesses to form partnerships that help expedite research activities.  Under this CRADA, PATH-MVI provides HHS/FDA with about $1.5 million to develop tests for malaria vaccines composed of live, weakened (attenuated) parasites, an approach intended to enhance the ability of vaccines to protect more reliably against infection, something that has so far been difficult to achieve.

To date, no approved vaccines exist to prevent malaria, but several are in development.  This CRADA will help develop laboratory tests to assess whether a vaccine candidate is safe enough to begin Phase I clinical trials.

HHS/FDA's Global Vaccine Initiative fosters the development, evaluation and availability of vaccines needed to protect against major global infectious diseases, and is part of the HHS' commitment to work with others, including the World Health Organization, in advancing global public health.

PATH is an international, non-profit organization that creates sustainable, culturally relevant solutions to improve global health and well-being.  PATH-MVI supports the development of malaria vaccines, and is expected to spearhead the efforts to ensure their availability and accessibility in the developing world once a safe and effective vaccine becomes available.

Last revised: October 08, 2008