World’s first malaria vaccine one step closer

The most promising malaria vaccination to date has been in development for 30 years and is designed to target babies in Africa.

Now, the European Medicines Agency has given a positive scientific opinion for the vaccine – known as RTS,S or Mosquirix – to be used outside of the European Union after assessing its safety and effectiveness.

It represents a “green light” for the jab to reach next stage. Now the World Health Organisation will have to examine the vaccine, which has received mixed results after years of trials.

Major killer

Malaria killed an estimated 584,000 people in 2013, the vast majority of them in sub-Saharan Africa.

More than 80 per cent of malaria deaths are in children under the age of five and this new vaccine will target babies between five and 17 months to help build and immunity to the disease early.

I have absolutely no reservations in terms of rolling this vaccine out. Joe Cohen, GSK scientist

Mosquirix is being developed by British pharmaceutical company GlaxosSmithKline and has cost more than £360m in research and development so far.

GSK has been working in partnership with the PATH Malaria Vaccine Initiative. Should the drug be rolled it, it will be the first licensed human vaccine against the mosquito-borne disease. It could help prevent millions of cases of malaria in countries that use it at around $5 per dose, according to reports.

Controlling the impact

Andrew Witty, GSK’s chief executive, said EMA’s positive recommendation was an important step towards making the vaccine available.

“While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions… 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,” he said.

Mosquirix is intended to protect against malaria but does not cure it. Because of the complex make-up of the vaccine’s composition, it also protects against hepatitis B.

Malaria is caused by a parasite carried in the saliva of mosquitoes. GSK’s vaccine is designed to go to work at the point the parasite enters the human bloodstream after a mosquito bite and stimulate an immune response.

Read more: Promise of world's first malaria vaccine by 2015

Partial protection

While the vaccine could be a final answer to wiping out malaria, some specialists have expressed concerns that the costs of developing the first vaccine when it only provides partial protection could make it more risky.

A report published in the Lancet medical journal in April found the vaccine only offers 50 per cent protection in babies between five and 17 months, and drops to 30 per cent for babies around three months.

Children would also need for four doses over 18 months as the effects of the vaccine weaken over time.

“The timing, duration, and outcomes of some of the critical steps to possible vaccine implementation in African countries are not yet known,” said David Kaslow, PATH’s vice president of product development.

‘Enormously significant’

But GSK say it will make no profit from Mosquirix pricing and will reinvest in research on malaria and other tropical diseases. It is also part funded by the Bill & Melinda Gates Foundation.

GSK scientist Joe Cohen, who has led the development of Mosquirix since 1987, said he would have “no reservations” in bringing the vaccine to market.

“I have absolutely no reservations in terms of rolling this vaccine out. Why? Because the efficacy, when translated into cases averted and deaths averted, is just tremendous. It will have an enormously significant public health impact,” he said.

The WHO has promised to make a decision on whether and how to recommend use of Mosquirix by the end of 2015. Before being rolled out in Africa, the vaccine will also need agreement from governments and other funders that it is worth using.