"For us, it’s a beautiful discovery," says Dr Iyam Ugot, a key player in the roll out of a new life-saving anti-malarial drug called injectable artesunate in Nigeria's Cross River State. "It's easier to administer and once you give it, the patient responds very well."
Injectable artesunate is a rapidly acting drug that kills the parasites that cause malaria. In 2010, the World Health Organization authorised aid agencies to supply the drug as the preferred first line treatment for severe malaria. Since then, an estimated 12 million vials have been distributed and between 80,000 to 90,000 additional lives have been saved.
But despite its effectiveness, injectable artesunate is still out of reach for millions of people who need it. At least 627,000 people died of Malaria in 2012, mostly African children.
Join Dr Javid Abdelmoneim in Nigeria for this special episode of The Cure, to see how the international drive to increase access to injectable artesunate is saving young children's lives.
|The 30-year search for a vaccine against malaria
By Dr Ripley Ballou
It began very suddenly. One minute I was enjoying a sunny afternoon party with friends and the next I realised something was definitely not right. It had nothing to do with the sun or the food I was enjoying. Instead, the culprit was malaria - a disease that kills hundreds of thousands of people each year, most of them children in sub-Saharan Africa, and sickens many more.
The experience of developing malaria was both terrifying and a revelation. For more than two days, I was wracked with chills, tremors, a high fever and severe headache. Although I was fortunate enough to recover, the experience was life-changing. It made me focus the rest of my professional career on fighting this disease.
So why had I, a young scientist working in the US, got malaria at all?
It was all in the name of research. Along with my colleagues at the Walter Reed Army Institute of Research, I was working on an experimental vaccine against malaria that was being developed with the healthcare company GlaxoSmithKline (GSK). At the time, researchers were permitted to test experimental vaccines on themselves and other healthy colleagues who volunteered.
And so we did, rolling up our sleeves to let mosquitoes – all infected with the falciparum malaria parasite – feed on our blood. Most of us got sick with malaria. But one of our colleagues did not succumb, suggesting for the first time that a vaccine could protect humans from malaria. This was hugely exciting, and it gave us hope that a vaccine could be possible. That was back in 1987.
After a number of false starts and disappointing failures, an improved version of the investigational vaccine is now being tested in young children in late-stage clinical trials across Africa. These have involved nearly 15,500 children across Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania. The candidate vaccine is designed to target infection caused by Plasmodium falciparum, the most deadly species of the malaria parasite. The majority of malaria cases and deaths caused by this parasite occur in sub-Saharan Africa, among children under five.
Data from the ongoing late-stage trial suggest that over 18 months of follow-up, the candidate vaccine can almost halve the number of cases of malaria in children aged 5 to 17 months, on top of reductions seen through the use of bed nets and other tools, and reduce by around a quarter the malaria cases in infants aged 6 to 12 weeks. While this seems modest, each year there are over 100 million malaria cases in African children under 5 years of age. Easing this disease burden would have a significant human, social and economic benefit.
And now, we have come a step closer to making available the world's first vaccine that can help protect children in Africa from malaria – GSK has submitted the candidate vaccine for scientific assessment by the European medicines regulatory agency. This submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. If it is approved and recommended by global and national public health policymakers, we could have the first malaria vaccine – and first ever vaccine against a parasite – within the following few years.
This is extraordinary but getting here has not been easy. There have been challenges both scientific and economic that we have had had to counter, including how to fund the development of a vaccine that would eventually be used by people that could not be expected to pay for it – children in Africa.
It is important to remember as well that a vaccine would not be a 'silver bullet'. Alone, a vaccine would not defeat malaria. While tools such as bed nets and insecticide sprays have made a significant dent in malaria's grip, deaths from the disease remain stubbornly high among children in Africa. A vaccine could provide another crucial tool in our armoury against malaria, used alongside these other interventions.
This is why GSK along with its partner, the PATH Malaria Vaccine Initiative, and researchers across Europe, the US and Africa have persisted with its development.
At times it might have seemed impossible, and there are many scientists who remain sceptical that the body's immune system could ever be harnessed against malaria – but this is what inspires us. Malaria is devious. It has evolved to escape our natural immune defences and has found efficient ways to overcome the highly targeted treatments that have been developed to combat it.
Not just that, but the infectious form injected by mosquitoes spends only minutes in the bloodstream before heading to the liver where it quietly grows, giving very little time for the body's defences to respond. After about a week, it breaks out in huge numbers that can overwhelm our immune defences and cause the clinical disease we recognise as malaria.
Knowing that the parasite has mastered the art of eluding the human immune system, researchers behind the vaccine, known as RTS,S, focused on the form of the parasite that is injected by the mosquito. They have fused a portion of one of the main surface proteins to a surface protein of a virus that the body can more readily recognise, in this case the hepatitis B virus surface protein.
The hypothesis is that this would help to stimulate the immune system to prevent infection by the malaria parasite before it escapes the liver and breaks out into the blood. Alongside that, there is an "adjuvant" system to boost the immune response, significantly increasing the levels of antibodies that can block infection of liver cells and harnessing T-cells to attack any parasites that may escape and go to ground in the liver.
There is still some way to go with developing the candidate vaccine. Submitting the candidate vaccine for scientific assessment is an involved process. If it is approved by regulators, we will then start the journey to get it to patients, which will require working closely with a number of other organisations.
On top of the ground-breaking science and profound impact it could have, the vaccine needs to be affordable to African countries and international organisations who would purchase the vaccine so that it can be free at the point of delivery for those children who need it. That is why GSK has said that the eventual price of RTS,S will cover the cost of manufacturing together with a small return of 5 percent that will be reinvested in R&D for next-generation malaria vaccines or vaccines against other neglected tropical diseases.
Although we are still a long way away from defeating malaria entirely, the initial, difficult steps are being taken. Now, we must maintain momentum against the disease. If we are to make malaria history, we will need to keep innovating, coming up with new and different ways to outwit this parasite for good.
Dr Ripley Ballou has worked to develop a malaria vaccine for more than 30 years and is co-creator of the RTS,S malaria vaccine candidate, which is currently in late stage testing in sub-Saharan Africa. He is vice president and head of clinical research and translational science in the vaccines division at GlaxoSmithKline.
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