Application for First Malaria Vaccine Submitted to EMA

July 29, 2014

British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative.

The drugmaker said that the RTS,S vaccine, submitted to the European Medicines Agency, is meant to target the Plasmodium falciparum parasite before and after it infects liver cells. The product is composed of sequences from the parasite’s protein and the hepatitis B surface antigen.

The parasite is highly skilled at evading the human immune system, but the immune system can more easily produce a response to hepatitis B, which in turn could protect patents from the parasite, GSK spokeswoman Mary Anne Rhyne said.

GSK’s application was supported by data from its Phase III vaccine trial program begun in May 2009 and conducted on 15,460 children across 11 research centers in various African countries. Pediatric patients were split into groups of infants given the vaccine at six, 10 and 14 weeks and older babies inoculated for the first time between five and 17 months.

Results showed that the vaccine could reduce cases of clinical malaria by 46 percent in young children and 27 percent in infants after 18 months of follow-up.

The EMA and World Health Organization will now evaluate the quality, safety and effectiveness of the vaccine under a provision that grants the agencies the right to evaluate applications for products used outside of the European Union that treat pressing public health problems.

P. falciparum is found largely in sub-Saharan African countries. According to WHO, in 2013, 97 countries reported active malaria transmission, with 77 percent of deaths occurring in children under the age of 5.

WHO said it expects to make its recommendations on instituting a malaria vaccine policy in 2015. GSK said that it anticipates the vaccine will be used most effectively in combination with other prevention measures, such as malaria medicines and mosquito netting. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.