- Title: KENYA: Scientists anticipate world's first effective malaria vaccine by 2015
- Date: 14th December 2010
- Summary: VARIOUS OF A MOTHER AND CHILD SLEEPING UNDER A MOSQUITO NET
- Embargoed: 29th December 2010 12:00
- Keywords:
- Location: Kenya, Kenya
- Country: Kenya
- Topics: Science / Technology
- Reuters ID: LVA1M51X192MYVD50843LLH9RWWQ
- Story Text: Scientists involved in the trial of a vaccine against malaria say they are optimistic they could be rolling out the first malaria vaccine in Africa by 2015.
In clinical trials, GlaxoSmithKline's (GSK) 'RTS,S' was the first vaccine to demonstrate that it can protect young children and infants in malaria-endemic areas against infection by Plasmodium falciparum, the most deadly species of the malaria parasite.
In a small dispensary in Madamani village within Kilifi district on Kenya's north coast, the drug maker is using the clinic as part of Africa's biggest ever medical experiment, giving the vaccine to babies and young children in a trial designed to assess its efficacy.
The Phase III clinical trial builds on more than 20 years of RTS,S research and development, including ten years of clinical trials in Africa.
The vaccine was invented and developed in laboratories at GSK Biologicals' headquarters in Belgium in the late 1980s.
This phase of trials involves up to 16,000 infants and children at 11 sites in across seven African countries; Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania, making it the largest malaria vaccine trial to date.
"We do know that vaccines have made a big impact to all children in terms of mortality. Towards an African scientist, just because this is one trial, one of the largest trials in Africa, for a disease in Africa, that is actually led by African scientists, in all centres that you go you will find an African scientist. So, that I think that is a land mark thing but even more importantly is that we are trying to bring our own solutions to our problems. I think that is very key," said Dr. Patricia Wambui Njuguna, principle investigator for Phase III Malaria Vaccine.
The vaccine developed combines technology from GSK's hepatitis B shot with pieces of the malaria parasite, and adds in a chemical known as an adjuvant to boost the body's immune response further.
The result, the first ever vaccine against a human parasite, as opposed to simple bacteria or viruses, is a product that could be given alongside standard infant vaccines and has been shown in a Phase II, or mid-stage, clinical trial to reduce the risk of clinical episodes of malaria in young children by 53 percent over eight months.
If all goes according to plan, the vaccine could be licensed and rolled out as soon as 2015.
"At this point with the vaccine that we are taking forward, this is what we have seen in previous trials and we expect this to be the result from this trial but in future trial's we do expect to develop a second generation vaccine which we hope will have higher efficacy," said Njuguna.
As governments in poor countries and donors from wealthy ones weigh up where to put their money, experts have begun a quiet but fundamental debate about whether wiping out malaria is realistic or even makes economic sense.
But for some mothers who have seen their children suffer from the disease, all they really want to see is a way to prevent the illness.
"Malaria is not good it is very bad, because it is a bad disease if you were to get it you would feel bad not good at all," said Dama Ng'umbao, the mother of a child going through the vaccination.
According to scientists working on RTS,S the vaccine would be an addition to the tried and tested low-tech approaches like mosquito nets and insecticides in wiping out the disease that threatens more than a third of the world's population and kills some 900,000 people a year, most of them in Africa.
"Where we have seen nets used and all those other interventions, Malaria has not completely gone away so, we do not want to put our eggs all in one basket, I think we need to look at different interventions and also looking from past history we do know that malaria parasite keeps changing, their vectors keep changing and we do need to be able to have something new in the arsenal, every time," said Njuguna.
Malaria is caused by a parasite carried in the saliva of mosquitoes. GSK's vaccine goes to work at the point the parasite enters the human bloodstream after a mosquito bite.
By stimulating an immune response, it can prevent the parasite from maturing and multiplying in the liver. Without that response, the parasite re-enters the bloodstream and infects red blood cells, leading to fever, body aches and between 1.5 and 2.7 million deaths per year - the world's second biggest killer after tuberculosis.
Under current plans, the file for the RTS,S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 5-17 months of age.
Additional safety and immunogenicity data from the infant population will be submitted soon thereafter, followed by efficacy data for infants once available. If all goes well, general implementation of RTS,S for infants 6 to 12 weeks of age is possible within five years or so.
The vaccine could be available for targeted use among young children 5 to 17 months old as early as 2015.
Once RTS,S is licensed, GSK and The PATH Malaria Vaccine Initiative (MVI) will work to ensure the vaccine reaches the children and infants who need it most.
Whether that happens will depend on securing funding and, crucially, how much the vaccine costs -- a figure health care experts and donors still do not know.
GSK has promised it will be cheap, with a profit margin of 5 percent over the cost of making it to be reinvested in new vaccines for malaria and other neglected diseases.
But the company has yet to give an exact figure to enable direct comparison with, say, the cost of insecticide-treated mosquito nets -- currently available for around $5 each.
The uncertainty on price is one of the reasons for the debate about how, where and on what scale the new vaccine -- designed exclusively for children in Africa -- should be used.
The cost-benefit analysis that donors must make when they work out where to spend their money is sure to be a lot more complex with this vaccine than with those targeting other diseases such as polio and smallpox.
For those diseases, vaccines virtually guarantee (or guaranteed, in the case of smallpox, which was eradicated in 1979) people won't get sick. With malaria, the picture is more complex, given its transmission cycle via mosquitoes and the practical steps that can already be taken to reduce the risk of infection.
MVI and GSK are already working with African countries to start preparing for the day when a malaria vaccine is routinely available.
Other vaccines in the pipeline are 10 years away or more. PATH Malaria Vaccine Initiative (MVI), a non-profit organization based just outside Washington D.C. that has channelled more than $200 million in grants from the Gates Foundation into the GSK vaccine (alongside more than $300 million from the drug maker itself), has a long-term goal of developing a vaccine that is at 80 percent effective by 2025. - Copyright Holder: FILE REUTERS (CAN SELL)
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