PATH Malaria Vaccine Initiative welcomes positive opinion by European regulators on GSK's Mosquirix™ (RTS,S)
Decision paves the way for World Health Organization to assess how a malaria vaccine might be used in young children in sub-Saharan Africa
Innovative partnership supported scientific achievement
WASHINGTON, DC (24 JULY 2015)—PATH's Malaria Vaccine Initiative (MVI) today welcomed the positive scientific opinion adopted by European regulatory authorities for GSK's candidate malaria vaccine Mosquirix™ (RTS,S) for prevention of malaria in young children aged 6 weeks to 17 months in sub-Saharan Africa. PATH was joined in its response by leading African researchers from sites that conducted the pivotal Phase 3 efficacy and safety trial.
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. This assessment requires medicinal products to meet the same standards as those intended for use in the European Union. The procedure for RTS,S was initiated in July 2014, following submission of a regulatory application by GSK.
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."
Dr. Kaslow continued, "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."
Final results from the Phase 3 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 3 program were conducted by 13 African research centers in eight African countries* and included more than 16,000 infants and young children. The trials were overseen by the RTS,S Clinical Trials Partnership Committee (CTPC), which brought together scientists from Africa, Europe, and North America.
Dr. Kwaku Poku Asante, a principal investigator for the Phase 3 trial at the Kintampo, Ghana, trial site and chairperson of the CTPC said, "On behalf of the network of clinical trial sites that provided the data that underpins today's opinion, I can say that we are all very proud of how far this vaccine candidate has come. While the story is far from over, we have already made history, demonstrating once again the capacity of African research scientists to conduct world-class research here at home and the willingness of African families to contribute to the well-being of their communities and nations."
Speaking from Kenya, Dr. Patricia Njuguna, a principal investigator for the Phase 3 trial at the Kilifi, Kenya, trial site and past co-chair of the CTPC said, "Every day, I see first-hand the enormous toll malaria takes on children, families, and communities here in Kenya and across Africa. The prospect of a malaria vaccine coming one step closer to reality is good news. Clinical trial data has indicated that RTS,S—if deployed correctly—has the potential to prevent millions of cases of malaria in sub-Saharan Africa. We as investigators look forward to the guidance from the WHO on recommended deployment of this new tool in the fight against malaria."
Next steps
Review by the WHO is the next milestone through which RTS,S has to pass. WHO has indicated that a policy recommendation is possible by the end of this year. This formal WHO review process is designed to assist in the development of optimal prevention and treatment guidelines for diseases that have a global public health impact. Other steps along the pathway to possible implementation include WHO prequalification, which signals to endemic countries and agencies that finance or procure vaccines that the manufacturing process meets international standards, and decisions by the countries themselves regarding domestic licensure and implementation.
As RTS,S heads toward possible licensure by national regulatory agencies in sub-Saharan Africa, PATH is helping to provide some of the critical information needed by endemic countries to make timely, evidence-based decisions about adoption of a malaria vaccine. Noted Dr. Kaslow, "In parallel with efforts to develop malaria vaccines, PATH has worked in Africa to improve the use of data in the fight against malaria, and has supported research on people's beliefs and perceptions about malaria and immunization programs. We're also doing considerable work to understand and address the potential challenges of implementing a partially effective vaccine against malaria, as well as implementation in different age groups."
Dr. Kaslow continued: "However, the timing, duration, and outcomes of some of the critical steps to possible vaccine implementation in African countries are not yet known. Positive outcomes throughout the policy and regulatory process, as well as the availability of the necessary financing, are a prerequisite for the introduction of RTS,S through African national immunization programs. That said, today the malaria vaccine development effort has reached a long-standing landmark on the road to safe and effective malaria vaccines."
* Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania
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The PATH Malaria Vaccine Initiative (MVI) is a global program established at PATH through an initial grant from the Bill & Melinda Gates Foundation. MVI's mission is to accelerate the development of malaria vaccines and catalyze timely access in endemic countries. MVI's vision is a world free from malaria. For more information, please visit www.malariavaccine.org.
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