Historical step forward in the fight against malaria

Today, I would like to welcome the recommendation by the World Health Organization (WHO) to broadly deploy the #malaria #vaccine for children?in sub-Saharan Africa. This decision marks a historical step forward in the fight against the disease and will have significant positive impact on the health of children in Africa and more generally on #GlobalHealth.

Malaria remains a huge burden for global public health and mostly kills children under five years old. They account for around two thirds of all malaria deaths worldwide. Over 90% of all malaria cases and deaths occur on the African continent.

The vaccine, Mosquirix (also known as RTS,S/AS01), is the first and – as yet – only approved malaria vaccine. It received a positive scientific opinion from EMA in July 2015 for use in areas where malaria is endemic, for the active immunisation of children aged six weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B. After decades of research into malaria vaccinations, it became the first vaccine for the disease to be assessed by a regulatory agency.

Mosquirix was submitted to EMA under a regulatory procedure known as EU-M4all (previously Article 58) which allows the Agency to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, even though it is not intended for use in the EU. It is one of the most important tools available to EMA to contribute to global public health by increasing access to high quality, safe and effective medicines for patients in low- and middle-income countries. The scientific assessment of Mosquirix was carried out in cooperation with WHO and experts from National Regulatory Agencies in Africa.

Initially, Mosquirix was rolled out in a pilot programme?in Ghana, Kenya and Malawi, during which more than 800,000 children received at least one dose of the vaccine. I am pleased that the findings of the pilot confirm EMA’s regulatory assessment and that the road is now paved for systematic roll-out to millions of children. This vaccine will save tens of thousands of lives per year and drive down child mortality in African countries.

#EUM4all combines EMA's scientific review capabilities with the local?epidemiology?and disease expertise of WHO and national regulators in the target countries, to provide a unique development and assessment pathway. The overall goal is to contribute to addressing unmet medical needs for people living outside the EU.