Late-phase data has tempered expectations for GlaxoSmithKline's ($GSK) malaria vaccine. Yet while the vaccine prevents fewer cases than hoped and immunity wanes, it still has the potential to cut incidence of disease. Glaxo is readying for a regulatory submission. A malaria vaccine could arrive in 2015.
Glaxo shared the timeline after posting late-phase data from Africa's largest-ever clinical trial, which recruited more than 15,000 children in 7 countries. The incomplete immunity seen in the earlier trials again cropped up in the new study data, but in the 18 months following vaccination, the jab still halved the number of cases of malaria in infants. Vaccinated babies also experienced a 27% fall in cases of clinical malaria. The data is expected to form the basis of a regulatory application to the European Medicines Agency (EMA) in 2014.
If EMA approves the vaccine, Glaxo could begin distribution in 2015. With malaria killing 660,000 people a year, the potential of even an imperfect vaccine is huge. "While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive," GSK CEO Andrew Witty said. GSK will sell the vaccine for 5% more than the cost of manufacture, with the slim-profit margin being put back into malaria research.
So far, GSK has invested $350 million in the vaccine--with the Bill & Melinda Gates Foundation providing another $200 million--and expects to spend a further $260 million to complete development. Some of that money will go into the ongoing African trial. Participants were given a booster shot 18 months after receiving the first three doses, and GSK is assessing its effect on immunity. Data from the 32 month follow-up is expected next year.