Malaria candidate RTS,S receives positive opinion by European regulators

Today, the European Medicines Agency (EMA) has adopted a positive scientific opinion for the malaria vaccine RTS,S also known as MosquirixTM in children aged 6 weeks to 17 months. This is a key step in the regulatory process towards making RTS,S available for people in sub-Saharan Africa. The malaria vaccine MosquirixTM developed by GlaxoSmithKline (GSK) has taken an important hurdle on the way to be licensed as the world's first malaria vaccine. The European Medicines Agency (EMA) has confirmed today that RTS,S is indeed applicable. "Following this decision, the World Health Organization must now formulate a policy recommendation on how the vaccine might be used alongside other malaria interventions" says professor Marcel Tanner from Swiss Tropical and Public Health Institute (Swiss TPH) who has been engaged in malaria vaccine development for the past 25 years. Green light given by EMA was based on the review of data assessing the candidate vaccine's safety, efficacy and quality. Clinical data submitted for EMA assessment mainly stem 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.