Delivering a Vaccine for Africa
12/02/2010
Dr. Marc LaForce tells how the Meningitis Vaccine Project - and its partners - developed a vaccine to combat a deadly epidemic
By Marc LaForce
On Dec. 6, a child in Ouagadougou, Burkina Faso will step forward from a long line of neighbors to receive a new vaccine against the epidemic meningitis that threatens more than 450 million people in sub-Saharan Africa. When she does, I'll be present, and ready to celebrate the start of the first nationwide campaign using MenAfriVacTM, a vaccine developed specifically for Africa through the Meningitis Vaccine Project. I suspect, though, that from time to time that day my thoughts will wander back nearly 10 years, to the summer of 2001.
As director of the then-newly formed Meningitis Vaccine Project, I spent much of that summer in Africa listening to public health officials talk about the need for an effective, long-lasting vaccine against group A meningococcal meningitis. The disease regularly ravaged their people in epidemic waves, killing one in 10 who contracted it and leaving up to a quarter of survivors with serious disabilities. But one of the most affecting things I heard that year had nothing to do with morbidity or mortality. It had to do with economics.
"Please don't give us a vaccine that we can't afford," an official from Niger told me. "That's worse than no vaccine."
Finding the right partners
The story of MenAfriVac'sTM development, licensure and distribution is an inspiring one, marked by an abundance of creative partnerships between individuals and organizations that were almost fanatically dedicated to the project's success. At the beginning, though, we seemed to have very little going for us.
As the project team began meeting with pharmaceutical companies to discuss developing an affordable conjugate meningitis vaccine, we soon realized that no one in the developed world could produce the vaccine we wanted at the cost we needed. If we were to make this vaccine at a sustainable price for Africa, we'd have to find alternative partners and come up with a different kind of product development plan.
In 2002, we found a way to meet our US$0.50-a-dose price point: we partnered with a developing country vaccine manufacturer, the Serum Institute of India Ltd. The leadership of Serum Institute understood the critical need to make a vaccine that potential users could afford, and they made a conscious decision to be as frugal as possible to meet price requirements.
With our manufacturer in place, we turned to Serum Institute and Synco BioPartners in Amsterdam to supply raw materials: the protein tetanus toxoid that would be chemically joined to the group A polysaccharide antigen, boosting the immunogenicity of the polysaccharide and creating a conjugate vaccine.
But we still needed access to the conjugation technology - intellectual property that is valuable and highly protected. This was one of our most difficult early challenges. Fortunately, we found Dr. Robert Lee and Dr. Carl Frasch, two scientists at the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration who had developed a new conjugation method - and believed in our mission. The project acquired the technology, and, with help from the National Institutes of Health, we transferred the technology within months to the Serum Institute at almost no cost.
Meeting regulatory standards
As the project team worked to bring the vaccine together, we were also moving toward meeting the regulatory and technical standards that govern new vaccines, setting up clinical trials to test the vaccine's safety and efficacy, and strengthening countries' ability to host clinical trials and administer vaccine once it was available.
We accomplished our goals through three partnerships set up very early in the project. A panel of pharmaceutical and clinical trial experts oversaw vaccine development and gave guidance in choosing a manufacturing partner. A group of consultants with expertise in carbohydrate chemistry, vaccine regulatory issues, and pharmaceutical development helped address questions and problems that arose during vaccine development. And a WHO project advisory group, made up of senior African public health officials, advised us on the choice of African clinical trial sites and design of trials.
We launched our first clinical trial in 2005. By 2009, we had enough clinical data to submit the vaccine dossier to the Drugs Controller General of India for Indian licensure and to WHO for prequalification for use in Africa.
In 2010, MenAfriVac cleared its final hurdles. The Maharashtra state Food and Drug Administration in India granted Serum Institute marketing authorization to export and use the vaccine in Africa. Next, WHO announced prequalification of the vaccine, certifying that it meets international standards of quality, safety, and efficacy.
Hope for the future
In the days after that child in Ouagadougou receives a dose of MenAfriVac, she or he will be joined by millions more in Burkina Faso, Mali, and Niger, three countries most affected by epidemic meningitis. Afterward, our hope is the vaccine will find support that will provide for its use in the rest of the 25 countries of the meningitis belt.
I will confess that we have a long way to go. But I also remember how far we've come. A lot of people said the idea of developing and delivering an affordable vaccine for Africa was just foolishness. It couldn't happen.
But it did.
Dr. Marc LaForce is director of the Meningitis Vaccine Project, a partnership between PATH and the World Health Organization funded by the Bill & Melinda Gates Foundation. See more blog posts, video and photos of the launch.
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