Pilot launch complete: GlaxoSmithKline's malaria shot scores WHO backing for wider rollout in Africa

GSK
After years of testing in a pilot program, GlaxoSmithKline's malaria vaccine scored a World Health Organization recommendation for a wider rollout in Africa. (Eric Sagonowsky)

GlaxoSmithKline has spent many years developing and testing its world-first malaria vaccine, but even after a positive recommendation from European regulators in 2015, the shot still isn't widely deployed. That's set to change with the World Health Organization's (WHO's) blessing for the vaccine.

Wednesday, the WHO recommended a wider use of the shot—known as RTS,S—in children in sub-Saharan Africa and other areas with moderate to high levels of malaria transmission. Specifically, WHO recommends a four-dose course of the vaccine starting at five months of age to help protect against Plasmodium falciparum malaria and to lower the overall disease burden.

GSK's vaccine, also known as Mosquirix, won a recommendation from the European Medicines Agency back in the summer of 2015. Shortly after, the WHO called for pilot projects to test its efficacy rather than wide rollouts. The pilot projects were designed to test the vaccine in the real world rather than in carefully controlled clinical trials. 

RELATED: GSK's malaria vaccine hits roadblock as WHO recommends pilot projects

Now, it seems the WHO has seen enough. The agency said it's recommending the shot based on a pilot program in Ghana, Kenya and Malawi that reached 800,000 children in recent years.

In anticipation of the WHO recommendation, GSK has been gearing up to support a wide rollout, the company said in a statement. The pharma giant pledged to donate 10 million doses for the pilot programs and will supply up to 15 million doses annually at "no more than 5% above cost of production."

GSK also started a product transfer process with India's Bharat Biotech to further bolster supply, the company said.

RELATED: Gavi floats $27.5M for pilot studies of GSK's Mosquirix

The WHO recommendation marks the second win for the vaccine program in recent months. Back in August, researchers reported that after three years, the combination of the vaccine and seasonal antimalarial drugs lowered the number of clinical episodes of malaria, hospital admissions from malaria and deaths from malaria by about 70% compared with the seasonal drugs alone. The data from more than 6,000 children showed that the shot could be introduced on top of existing antimalarial measures to further fight the disease, GSK said.

The shot is the result of more than 30 years of research by GlaxoSmithKline, global nonprofit PATH and other partners.

Malaria is a leading cause of illness and death among children in sub-Saharan Africa. The disease kills more than 260,000 children under the age of five in Africa each year.