• by Susan Anyangu (nairobi)
• Wednesday, November 04, 2009
• Inter Press Service

After 20 years of trials, scientists have announced they are on the threshold of discovering a malaria vaccine. Researchers warn that Africa may not be ready to make use of the vaccine should it be approved as expected within five years.

GlaxoSmithKline Biologicals' RTS,S is the first malaria vaccine to demonstrate a high level of efficacy. The vaccine is presently negotiating what will be the final hurdle before release as it enters Phase III trials in seven African countries.

RTS,S was specifically developed for use in Africa but Prof Wilfred Mbacham, a public health biotechnologist from the University of Yaoundé in Cameroon, says a failure by African governments to prepare adequately may rob millions of people access to the vaccine.

'As we pursue a breakthrough in the development of the vaccine, we need to begin speaking to African governments telling them how they should prepare to receive the vaccine. They need to prepare policy which will facilitate the inclusion of this vaccine into the Expanded Programme on Immunisation,' Mbacham says.

Regulatory systems in African countries which would be responsible for approving use of the vaccine are weak. Governments will also need to think how they will pay to inoculate populations, and master the details of where, how often, and in which groups of people malaria occurs in each country.

'African States will have to begin thinking about financing and how they will access the vaccine. While it is a possibility the Global Health Fund will provide money for this, governments need to explore other innovative financing methods,' Mbacham adds.

The RTS,S vaccine is intended primarily for infants; children under the age of five are the most vulnerable to malaria. After almost two decades of research and 10 years of trials, it is the first to reach Phase III, the final phase of testing.

'Phase II studies showed that RTSS reduced clinical episodes of malaria by 53 percent over an eight-month follow-up period. And findings from the Phase II trial in southern Mozambique on children showed RTSS was efficacious for at least 18 months in reducing clinical malaria by 35 percent and severe malaria by 49 percent.

'The vaccine has also shown a promising safety and tolerability profile when used alongside other WHO standard infant vaccines,' says Dr Joe Cohen a co-inventor of RTSS.

The Phase III trial will evaluate the vaccine's efficacy in two groups of children, one cohort aged six to 12 weeks and the other aged five to 17 months.

Sixteen thousand children will take part in the trials; five thousand have already been recruited. The trials are being conducted in seven African countries, including Kenya, Burkina Faso, Tanzania, Mozambique, Ghana, Malawi and Gabon.

Health experts warn the news of the impending approval of the vaccine does not mean people can discard the current malaria prevention measures including use of insecticide treated mosquito nets (ITNs) and indoor residual spraying.

'These technologies have worked so far and communities need to continue using them. Should the vaccine be approved, these measures will continue to be used. Indeed, research is ongoing on strengthening the insecticides and making the ITNs longer lasting,' says Michael MacDonald from the malaria programme of the U.S. Agency for International Development.

© Inter Press Service (2009) — All Rights Reserved. Original source: Inter Press Service

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