PATH’s Malaria Vaccine Initiative (MVI) says it welcomes the positive scientific opinion adopted by European regulatory authorities for GlaxoSmithKline (GSK) candidate malaria vaccine Mosquirix™ (RTS,S) for prevention of malaria in young children aged 6 weeks to 17 months in sub-Saharan Africa.
A statement copied to GNA said, PATH was joined in its response by leading African researchers from sites that conducted the pivotal Phase three efficacy and safety trial.
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The opinion is being adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), under the Article 58 procedure, by which the CHMP gives a scientific opinion, in cooperation with the World Health Organization (WHO), on a medicinal product for human use that is intended exclusively for markets outside of the European Union.
It said, this assessment requires medicinal products to meet the same standards as those intended for use in the European Union.
The procedure for RTS, was initiated in July 2014, following submission of a regulatory application by sGSK.
David C. Kaslow, MD, vice president of product development for PATH, said, “Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite. PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps.”
“Today’s scientific and regulatory landmark is a credit to GSK’s thirty-year commitment to malaria vaccine development and the innovative partnership forged with PATH, working in close collaboration with African research centers, to develop a first-generation vaccine to protect young children in sub-Saharan Africa against malaria.
“This opinion is an important step in the process that could result in RTS,S being available alongside existing tools currently recommended for malaria prevention. Today’s opinion underscores that it is technically possible to develop malaria vaccines and validates the continued investment in next-generation vaccines.” Dr. Kaslow added
Final results from the Phase three efficacy and safety trial, published in The Lancet earlier this year, showed that RTS,S helped protect children and infants from clinical malaria for at least three years.
In all, the clinical trials in the Phase three program were conducted by 13 African research centers in eight African countries,* and included more than 16,000 infants and young children. GNA