ARTICLE | Clinical News

RTS regulatory update

July 27, 2015 7:00 AM UTC

EMA’s CHMP recommended approval of Mosquirix from GlaxoSmithKline for active immunization of children ages 6 weeks to 17 months against malaria caused by Plasmodium falciparum and against hepatitis B. The malaria vaccine targeting the circumsporozoite protein (CSP) sequence of P. falciparum combined with the AS01 adjuvant is the first vaccine for malaria to be assessed by a regulatory agency for use outside the EU. GSK said the World Health Organization (WHO) will now formulate a policy recommendation on use of Mosquirix in national immunization programs once it is approved. ...