GSK and PATH joint statement on WHO advisory group recommendation on use of RTS,S malaria vaccine candidate

Contacts:
Preeti Singh, +1.301.280.5722, psingh@burness.com
Kelsey Mertes, +1.301.312.7844, kmertes@path.org.

October 23, 2015–The World Health Organization's Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Committee (MPAC) have today jointly recommended implementation of GlaxoSmithKline's (GSK) malaria vaccine candidate RTS,S (Mosquirix) through a number of pilot projects. This is an important step in the process toward making RTS,S available alongside existing tools currently recommended for malaria prevention, diagnosis, treatment, and control. GSK and PATH will now review the SAGE/MPAC advice as we wait for the final policy recommendation from the WHO expected by the end of 2015.

GSK and PATH stand ready to work with the WHO on the pilot implementation of the vaccine, in order to provide the additional information needed about how to best deliver the vaccine in a real-world setting, enabling implementation of a wider scale immunisation programme in children in sub-Saharan Africa (SSA). The results of a large scale phase III efficacy and safety trial of RTS,S, have shown that RTS,S could provide a meaningful public health benefit in reducing the burden of malaria when used alongside currently available interventions such as bed nets and insecticides.

The SAGE/MPAC joint recommendation comes after the vaccine candidate received a positive scientific opinion from the European regulators in July 2015 for the prevention of malaria in young children in SSA.

In 2013, there were an estimated 584,000 deaths from malaria with around 90 percent of these occurring in SSA, and 83 percent in children under the age of five.

RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA) and was developed by GSK in partnership with PATH's Malaria Vaccine Initiative. As part of the development programme, RTS,S has been studied in a large-scale phase III efficacy and safety trial, involving more than 15,000 young children that was conducted by 11 African research centres in seven African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania).

The final results of the efficacy and safety trial demonstrated efficacy with four doses after 3 to 4 years of follow up. RTS,S reduced the number of cases of clinical malaria in children (aged 5-17 months at first vaccination) by 39 percent to the end of the study and in infants (aged 6-12 weeks at first vaccination) by 27 percent to the end of the study. For children in the 5-17 month age category who received a fourth dose, an average of 1,774 cases of clinical malaria were prevented for every 1,000 children vaccinated over 48 months of follow up. For infants aged 6-12 weeks at first vaccination with RTS,S, who received a fourth dose, 983 cases of clinical malaria, on average, were prevented for every 1,000 infants vaccinated over 38 months of follow-up. More cases were averted in areas of higher disease burden. 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 percent of the children and infants in the trial.

GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around five percent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Posted October 23, 2015.