The world’s first malaria vaccine has just passed an important hurdle. The vaccine, which researchers have been working on for 30 years, has been given a green light by European regulators.
The European Medicines Agency has adopted a “positive scientific opinion” on the Mosquirix vaccine, which meets their criteria for efficacy, quality and safety. The World Health Organization (WHO) will next examine the efficacy profile of this vaccine and offer its own recommendation for how and if it can be used in the field.
The vaccine was specifically designed to be given to children. Malaria is a life-threatening disease, causing an estimated 584,000 deaths globally in 2013. The vast majority of these deaths are among African children. The WHO estimates a child dies every minute from malaria.
“This is the first time that a malaria vaccine has been presented to a regulatory authority. No malaria vaccine has ever got that far before," WHO spokesperson Gregory Härtl tells IFLScience. "This shows that we can actually make a malarial vaccine and that’s very encouraging for going forward with this work."
The vaccine has been shown to provide partial protection against the disease. In a clinical trial, 16,000 children in multiple African countries were given three shots of the malaria vaccine a month apart, followed with a booster shot at 20 months.
“We already have a standard program of immunization, which has been developed over the years with countries to get routine immunization on track with children across the world," said Härtl. "So, we will need to look at whether or not this malaria vaccine can fit into routine immunization programs.”
The findings, published in The Lancet earlier this year, showed mixed results. The vaccine gave children aged five to 17 months the best protection – severe malaria was reduced by 36% and episodes of clinical malaria was cut by 46%. In babies aged 6-12 weeks, the vaccine provided 15% protection from severe malaria and 27% from clinical malaria.
“The WHO will be looking at how cost effective the vaccine is compared to other interventions. There are a number of different considerations that two separate WHO committees will look into in October,” Härtl explains.
Research on the vaccine first started in 1998. It’s being developed by GlaxoSmithKline (GSK) and part-funded by the Bill & Melinda Gates Foundation. GSK has announced it will not be making a profit from the vaccine, which will be sold at cost plus 5%. The surplus will be reinvested in malaria and tropical disease research.
The vaccine will “without a doubt” be used to compliment other interventions, such as bed nets, vector control, developing diagnostics and developing other types of anti-malarial drugs. Härtl says that although a vaccine is always “one of the best public health tools,” it cannot be looked at in “isolation.”
If the WHO recommends the vaccine in Africa, then it will be up to individual countries to decide whether to adopt it or not.
Image credit: AMISOM via Flickr