The first ever vaccine for malaria has passed on of its final hurdles in the course of being approved for use in Africa. The European Medicines Agency gave it a green light following scientific checks into its safety and effectiveness and means it can continue on its course to full approval.
The drug, called Mosquirix, was developed by GlaxoSmithKline and will be considered by the World Health Organisation later this year. They will decide if to recommend it for children, among who there has been mixed results during the trials.
Killer
Malaria is responsible for around 584,000 deaths each year, the majority of them being children under the age of five and in Sub-Saharan Africa. The drug, also known as RTS’S, is the first against the infection in humans.
Dr Ripley Ballou, head of research at GSK vaccines, said that it was a hugely significant moment for a vaccine that he has been working towards for 30 years and that it is ‘a dream come true’. The company has not yet revealed the price of the treatment but have pledged not to make a profit from it.
The drug is aimed specifically at combating the infection in children in Africa and will not be available for travellers.
Children
The best protection was in children from five months to seventeen months who received a course of three doses a month apart then a booster dose when they reached 20 months old. In this group, the cases of malaria were cut over one-third across four years.
But the effectiveness of the drug waned over time so the booster shot was crucial and without this, the vaccine did not cut the rate of severe malaria cases in the trial period. The drug also didn’t prove very effective at protecting young babies from the infection.
This creates the dilemma for the WHO, who will decide in October if the vaccine should be deployed as it is not as effective as scientists had hoped.
Initially it had been hoped to administer the drug with other vaccines at six, ten and fourteen week but the results suggest the jab needs to start later, which would involve a great deal of organisation and extra cost.
Trials also showed that children needed to have all four doses to receive the full benefit but even a partially effective vaccine could have a big role in countries with very high rates of the disease.
Long-term project
GSK started to work on the vaccine 30 years ago and the first trials started in 1998. In 2001, a partnership between GSK and the PATH Malaria Vaccine Initiative, with a grant from the Bill and Melinda Gates Foundation, aimed to accelerate the development.
In 2009, eleven centres began recruiting 16,000 children across seven countries – Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania – to begin their trials.
The vaccine works by triggering the immune system to defend against the first stage of the infection, which comes from the Plasmodium falciparum parasite, which enters the bloodstream after a mosquito bite.
