GSK’s malaria candidate vaccine Mosquirix garners EMA’s nod

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One of world’s leading pharmaceutical companies GlaxoSmithKline (GSK) revealed that its malaria candidate vaccine Mosquirix also known as RTS,S has landed European Medicines Agency’s (EMA) positive scientific opinion for children aged 6 weeks to 17 months.

GSK developed the vaccine candidate in collaboration with the PATH Malaria Vaccine Initiative (MVI). The vaccine candidate is the first to reach this milestone. Unlike other vaccines that tackle viruses or bacteria, Mosquirix prevents malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA).

Considered to be a key step in the regulatory process towards making RTS,S available to the masses, the positive opinion for young children from Committee for Medicinal Products for Human Use (CHMP) of EMA was based on the review of data assessing the candidate vaccine’s safety, efficacy and quality.

Clinical data submitted for CHMP assessment were mainly from a phase III clinical trial programme involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania).

The results of the trial demonstrate that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27 per cent in infants aged 6-12 weeks.

At study end, four doses of RTS,S reduced malaria cases by 39 per cent over four years of follow-up in children, and by 27 per cent over three years of follow-up in infants. In areas of the highest malaria burden, more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated. The efficacy of RTS,S was evaluated in addition to existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80 per cent of the children and infants in the trial.

GSK has revealed that it will be pricing its RTS,S with a not-for-profit price tag and once it will get approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around five per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

This positive opinion means that the World Health Organization (WHO) will now formulate a policy recommendation on use of the vaccine in national immunisation programmes once approved by national regulatory authorities. WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) will jointly review the evidence base for RTS,S and make policy recommendation for how the vaccine candidate might be used alongside other tools to prevent malaria in. Chances are that the policy recommendation may be release by end of this year.

Following the WHO policy recommendation, GSK will also submit an application to the WHO for pre-qualification of RTS,S. WHO pre-qualification involves a scientific assessment of the quality, safety and efficacy of any new vaccine proposed for introduction in WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorisation in countries in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin implementation of RTS,S through their universal immunisation programmes.