First malaria vaccine given green light by European regulators

Bed nets combat the spread of malaria

Bed nets combat the spread of malaria [Gates Foundation/Flickr]

The world’s first malaria vaccine has been given the green light by European regulators and could protect millions of children in sub-Saharan Africa from the life-threatening disease.

The European Medicines Agency (EMA) recommended that RTS,S, or Mosquirix, should be licensed for use in young children in Africa who are at risk of the mosquito-borne disease. The shot has been developed by Britain’s biggest drugmaker GlaxoSmithKline (GSK) and part-funded by the Bill and Melinda Gates Foundation. It has taken 30 years to develop vaccine, at a cost of more than $565m (£364m) to date.

It will now be assessed by the World Health Organisation, which has promised to give its guidance on how and where it should be used before the end of the year. GSK will then apply to the WHO for a scientific review of the vaccine, which will be used by the UN and other agencies to help make purchasing decisions. The rollout of the vaccine, which also has to be approved by national health authorities in sub-Saharan Africa, is likely to be funded by Gavi, the vaccine alliance founded by the Gates Foundation.

According to the WHO, 627,000 deaths from malaria were reported globally in 2013, of which the vast majority (562,000) occurred in Africa, mostly among children under the age of five (82%).

The EMA said its committee of experts “considered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very high”.

The decision had been widely expected, even though the shot offers only partial protection against malaria in young children, and later booster shots are needed.

Justin Forsyth, chief executive of charity Save the Children, welcomed the news: “Malaria is one of the biggest killers of children in the world, killing one child every minute. Any new treatment should be made affordable and a part of continued efforts to ensure that comprehensive strategies are in place to prevent and treat malaria, including strengthening the health systems that will help deliver such treatments.”

Both the EMA and GSK stressed that the vaccine would need to be used alongside other tools such as bed nets and insecticides.

Sir Andrew Witty, GSK’s chief executive, hailed the EMA decision as a further important step towards making the world’s first malaria vaccine available for young children.

He added: “While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most.”

GSK will not make a profit from the vaccine, planning to set a price that would cover the cost of manufacturing it together with a small return of about 5% that would be reinvested in research into malaria and vaccines for neglected tropical diseases. The drugmaker is reportedly looking at pricing the shot at $5 (about £3.20) – the same as an insecticide-treated bed net.

The vaccine has been developed at GSK’s labs in Belgium in collaboration with the international non-profit organisation Path.

Ana Nicholls, healthcare analyst at the Economist Intelligence Unit, said: “It is tremendous news that GSK’s long-awaited malaria vaccine has gained approval in Europe. Despite huge progress in combating malaria, it remains one of the world’s deadliest diseases.”

She added that GSK’s vaccine was a “scientific breakthrough that others can build on”. Researchers at Brown University in the US, for example, are working on an experimental vaccine based on natural antibodies found in some children in Tanzania.

European Medicines Agency (EMA)

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