By: Marc Kusinitz, PhD
Meningococcal meningitis, a disease that sweeps across sub-Saharan Africa in an area called the meningitis belt, is losing its power to inflict illness and death. Scientists from FDA made a critical contribution in developing the technology needed to manufacture a vaccine against this terrible disease, and at an affordable cost for African nations like Burkina Faso, Chad, Ethiopia, and Niger.
Meningococcal meningitis can be deadly. It kills 10 percent of people it infects within two days after they start showing symptoms. Although an antimicrobial drug saves large numbers of infected individuals, about 10 percent die from the infection and about 10 percent to 20 percent of survivors develop mental retardation, hearing loss, or seizures. In Africa, most meningococcal disease is caused by the group A meningococcus bacteria, and about half of its victims are working-age adolescents and young adults. The disease results in very significant human, social, and economic losses to the affected communities and countries. Vaccination offers the best chance to prevent the disease and epidemic meningitis. However, an existing vaccine didn’t work very well.
Developing a Vaccine:
In 2001, the Bill & Melinda Gates Foundation agreed to fund the Meningitis Vaccine Project (MVP)–a partnership between the World Health Organization and PATH, a non-profit organization based in Seattle, WA that works with collaborating groups to provide health care technologies and strategies to areas of the world that have limited resources.
Dr. F. Marc LaForce led MVP’s effort to develop, test and license a new type of vaccine against group A meningococcus bacteria, that could protect people before an epidemic begins. The new vaccine, called a conjugate, is a chain of sugars connected to a protein that the immune system responds to very well. When MVP hit a hurdle during the development stage, FDA stepped in. Drs. Robert Lee and Carl E. Frasch, two researchers in the Office of Vaccines Research and Review in FDA’s Center for Biologics Evaluation and Research (CBER), had developed an alternative conjugation technology that was more efficient and less costly. Through a technology transfer agreement, FDA provided the technology to MVP via PATH, with help from the National Institutes of Health.
Scientists at CBER also developed reagents for evaluating the vaccine’s performance and safety and developed methods to monitor the manufacturing process. MVP had partnered with the Serum Institute of India Limited, a developing-country vaccine manufacturer, to make the new conjugated vaccine. In December 2003, two scientists from the Serum Institute came to Drs. Lee and Frasch’s FDA laboratory to learn the conjugation method to manufacture the vaccine.
After preclinical animal studies and a series of clinical trials in people in India and Africa’s meningitis belt to assess its safety and effectiveness, the new vaccine, MenAfriVac, was licensed in Dec. 2009 by India for export to Africa. By June 2010, the WHO had prequalified the vaccine for use in global immunization programs.
Launching the Vaccination Campaign:
MVP launched its vaccination campaign in Dec. 2010, beginning in Burkina Faso and moving on to Mali and Niger and eventually Cameroon, Chad and Nigeria. By the end of 2011, an estimated 55 million people had been vaccinated with MenAfriVac at a cost of only 40 cents per dose.
The contribution of CBER researchers Carl Frasch and Robert Lee was perhaps best summed up by MVP director Dr. LaForce in a news story about their timely contribution of the conjugation technology that enabled the development of MenAfriVac at a price that Africa could afford: “These guys are heroes.”
FDA’s contributions to a major health care project in Africa underscore the agency’s recognition that infectious diseases know no borders. Protecting human health globally is linked to the agency’s core mission of protecting human health in the United States.
Marc Kusinitz is Senior Science Communications Advisor in FDA’s Center for Biological Evaluation and Research