BioCentury
ARTICLE | Clinical News

RTS regulatory update

July 28, 2014 7:00 AM UTC

EMA accepted for review an MAA from GlaxoSmithKline for its RTS,S malaria vaccine - moving the product closer to being the first vaccine approved to prevent malaria infection in infants and children. There are currently no approved vaccines for malaria. A positive EMA opinion on the MAA would be the basis for regulatory applications for RTS,S in countries in sub-Saharan Africa, which accounts for about 90% of annual malaria deaths. GSK said it does not expect a decision on the vaccine until next year. Pending EMA’s decision, GSK said the World Health Organization also could issue an immunization policy recommendation for RTS,S by the end of 2015.

GSK is developing RTS,S - a vaccine that targets the circumsporozoite protein (CSP) sequence of Plasmodium falciparum and is combined with the AS01 adjuvant - with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative (MVI). ...