Académie royale de Médecine de Belgique

|

Joe Cohen (GSK) - Résumé + vidéo

The « Impossible » dream of a vaccine against malaria :A brief status report

par Joe Cohen (GSK consultant – Advisor to the Malaria Vaccine Program).

 

In July 2014, GSK announced that it has submitted a regulatory application to the European Medicine Agency (EMA) for its malaria vaccine candidate, RTS,S.   This submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an additional tool in the fight against malaria and as the first ever vaccine developed and registered against a human parasite.

The very thought of ever reaching this key milestone was no more than a wishful dream when research work on RTS,S was initiated some 27 years ago.

Data from a large phase 3 clinical trial conducted in 11 African countries, involving more than 15.000 young children and infants were included as a pivotal part of this regulatory filing.

These data have shown that the vaccine confers a significant level of efficacy against clinical malaria in young children 5-17 months of age (VE = 46%) and in infants 6-12 weeks old (VE = 27%), over an 18 months follow up period.

Illustrating the potential public health impact of this vaccine on a disease estimated to be responsible for approximately 200 million clinical cases leading to nearly 600.000 deaths a year, it was estimated that, over the 18 months following vaccination, and for every 1000 individuals vaccinated, 829 and 449 cases of malaria were prevented in young children and in infants, respectively.

In my presentation I will briefly describe the status of the field of malaria vaccines R&D.  I will then summarize the history of the development of RTS,S focusing on the major milestones reached and the salient results obtained thus far.  I will conclude with some remarks on what still needs to be done over the next few years in order to convert the dream of a life-saving malaria vaccine into a reality on the ground, in Sub-Saharan Africa.