By Gatonye Gathura
A group of globally influential medical experts is pressurizing regulatory authorities to have the world’s first malaria vaccine speedily rolled out in Africa.
This is the first expert reaction to the World Health Organisation’s (WHO) recommendation that the vaccine, Mosquirix, go for further clinical trials to ascertain unresolved safety and efficacy issues.
Last year, Mosquirix or RTS,S vaccine, developed by among others GlaxoSmithKline had been presented to WHO for what was largely expected to be routine approval for commercial rollout.
However WHO to the surprise of many, for a product that had already been approved by the European Medicines Agency for use in Africa recommended further clinical trials.
WHO said more data was required especially because of the high rates of meningitis, cerebral malaria and convulsions that were recorded during the previous clinical trials.
In December WHO advertised for countries in Sub-Saharan Africa with an interest to participate in the repeat trials to apply in an exercise that could take up to five years. The development of Mosquirix has taken almost 25 years.
It is this period between vaccine development and licensing that Katherine L O’Brien, Fred Binka, Kevin Marsh and Jon S Abramso, want reduced especially for vaccines meant for Africa.
In an online comment running in the May 7th issue of The Lancet, the team intimates that the ‘residual’ questions over Mosquirix can very well be answered while the vaccine is already out there in routine use.
In the comment largely addressed to WHO, donors and other major global health players the authors say unless this expensive gap is addressed, Africa my have a price to pay.
“Decisions on financing the malaria vaccine pilot studies are being made in the next few months and will have implications far beyond the malaria vaccine,” they warn.
The Team of Experts
Katherine L O’Brien is a committee member of the WHO Strategic Advisory Group of Experts on Immunization, previously served on the Data and Safety Monitoring Board for GlaxoSmithKline’s RTS,S vaccine, and has received a grant from GlaxoSmithKline for pneumococcal vaccine research.
Fred Binka is Malaria Vaccine Session Co-Chair for the WHO Malaria Policy Advisory Committee.
Kevin Marsh is Chair of the WHO Malaria Policy Advisory Committee and was a site principal investigator on the Malaria Vaccine Initiative’s phase 3 trial of GlaxoSmithKline’s RTSS vaccine,
Jon S Abramso is Chair of the WHO Strategic Advisory Group of Experts on Immunization.