Dr Joe Cohen recalls his experiences of being part of the team that has worked for almost three decades to develop what could be the world’s first vaccine against malaria
As a young scientist in the early 1980s, I had planned to head into an academic career. But a chance advert led me to a job at GSK’s vaccines division and eventually to working with a team developing a vaccine against malaria. This was truly inspiring. Malaria affects extremely vulnerable populations and, in particular, young children living in poor countries with fragile health systems. Anyone with the opportunity to alleviate this burden would want to do the right thing and attempt to tackle it.
No vaccine exists against malaria. Finding a vaccine is challenging because theplasmodium falciparum parasite, which causes the deadliest form of malaria in humans, is capable of adapting to the human host and escaping its immune responses. But 30 years after research began, the team I worked with is closer than ever to developing a vaccine that could help protect young children in Africa from malaria. Now I am retired, I feel fortunate to have been associated with this work.
When I started working on the project as a molecular biologist back in 1987, almost 80% of my time was spent in the laboratory, developing components of the vaccine. But my role evolved over the years so that by the time I retired I was responsible for three vaccine research projects at GSK: malaria, tuberculosis and HIV.
It was in 1996 that we made a breakthrough with our malaria candidate vaccine, RTS,S. A study we conducted in collaboration with the Walter Reed Army Institute of Research in Washington DC gave us an amazing result. Our vaccine candidate protected six out of seven volunteers who, after being immunised with RTS,S, were bitten by infected mosquitoes in the laboratory. This was an unprecedented result and a landmark in the field. For the team at GSK it marked the beginning of a long, clinical development road that included multiple trials in sub-Saharan Africa.
During one of these studies, the reality of the human burden of malaria became even more obvious. In the late 1990s, I visited The Gambia as we were preparing to test RTS,S in people in Africa for the first time. In the children’s ward of the local hospital, the 20 or so beds were each often occupied by two or three tiny children – most of them seriously ill with malaria. Their mothers sat beside them, clearly despondent and almost resigned: many told us they had already lost a child to this dreadful disease. The visit starkly illustrated what malaria meant for the local population and gave even more meaning and urgency to our work.
The Gambia study, conducted in 1999, demonstrated that the vaccine was effective in African adult volunteers and in 2004 our collaborators in Mozambique demonstrated the efficacy of the vaccine candidate in African children. These and other studies paved the way for the start of our final-stage study, Phase 3, in 2009 – a crucial step towards the registration of the vaccine candidate. To get this far would have been a dream only 10 or 15 years ago. We couldn’t grasp that it would actually happen. That was a tremendously big moment for all of us.
Even a partially effective vaccine could have a significant impact on the health of African children. In this context, I was pleased to see GSK has committed to make the vaccine available on a not-for-profit basis.
It was also the point at which more partners came on board to enable running what would be the biggest trial of its kind in Africa. Public-private partnerships offered a way to share cost and risk, and therefore pursue projects that were extremely challenging scientifically, but also difficult from an economic point of view.
The Phase 2 and Phase 3 trials in Africa were run with the PATH Malaria Vaccine Initiative, an NGO that had financial support from the Bill & Melinda Gates Foundation, and with African scientists who ran the trial on the ground. More than 15,000 children from across seven countries in Africa were enrolled in the trial.
Based on data from these trials, last year GSK submitted a regulatory application for the malaria vaccine candidate with the European Medicines Agency – the first step on the road to potential registration, recommendation and implementation of the vaccine. If approved, a malaria vaccine would offer an added tool – not a replacement for current malaria prevention methods.
Looking back on my working life, I feel incredibly fortunate. My days were busy, but exciting; in many ways they still are as I continue to act as a consultant to the malaria vaccine project. To be lucky enough to see my work translated into a vaccine that could save lives is something I could only have dreamed of when I started out in my career as a scientist.
In July 2015, the European Medicines Agency granted GSK’s malaria vaccine candidate a positive scientific opinion. The World Health Organization announced in January 2016 that it will be introduced to sub-Saharan African countries through a pilot implementation programme to be used alongside existing measures to fight malaria, such as bed nets and indoor residual insecticide spraying.
This feature first appeared on The Guardian - www.guardian/gsk-change - as part of a series exploring global health challenges. Prior to retiring, Joe Cohen PhD was head of vaccines for emerging diseases and HIV at GSK. He is an adviser to the malaria vaccine project at GSK. He was interviewed for this article.
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