GlaxoSmithKline has filed for approval of what could be the first-ever malaria vaccine in Europe, offering the possibility of widespread immunisation from early 2016.
The RTS,S vaccine is designed to protect against Plasmodium falciparum, the most dangerous of four species of the mosquito-borne malaria parasite that can infect humans and which is found most commonly in sub-Saharan Africa.
GSK notes that the vaccine’s marketing application will be reviewed by the European Medicines Agency and the World Health Organization (WHO) under a procedure known as Article 58 – which allows the EU regulator to assess a drug or vaccine intended for use for a major public health issue that falls outside its jurisdiction.
Around 90 per cent of deaths from malaria occur in sub-Saharan Africa, with children under five bearing the brunt of the disease, accounting for 77 per cent of all cases. All told, the disease kills more than 600,000 people a year.
Last year GSK reported phase III data with RTS,S which showed that children aged 5 to 17 months immunised with RTS,S had experienced 46 per cent fewer malaria episodes than those who received a control vaccine when assessed 18 months later.
This level of protection is fairly modest but the sheer scale of malaria infection means that even a partially effective immunisation strategy could have a dramatic impact on public health when used alongside other measures such as distribution of mosquito nets and treatment with antimalarial drugs.
GSK believes that a positive Article 58 review from the EMA could put WHO in position to make a policy recommendation by the end of 2015, which could encourage the start of immunisation programmes the following year.
The WHO previously said it may recommend use of RTS,S if the EMA backs the licence application, and a positive opinion from the regulator could also form the basis of approval in countries within the sub-Saharan Africa region.
“This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria,” said Sophie Biernaux, head of GSK’s malaria vaccine project.
News of the marketing application was also a boost for US biotech Agenus, which supplies the adjuvant used in RTS,S. Shares in the firm put on more than 11 per cent in the wake of the announcement.
Even if the vaccine is approved it will not be a money spinner for the company, as the company has pledged to make it available at a little above cost, with any profits made re-invested into malaria research programmes.