Press Release: First malaria vaccine receives positive scientific opinion from EMA

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), for use outside the European Union (EU).

The malaria vaccine Mosquirix, also known as RTS,S/AS01, was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU.

EurActiv, 30.07.15: First malaria vaccine given green light by European regulators http://www.euractiv.com/sections/development-policy/first-malaria-vaccine-given-green-light-european-regulators-316706

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