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PJ Online homeThe Pharmaceutical Journal
Vol 279 No 7474 432
20 October 2007

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First malaria vaccine set to be licensed

The world’s first partially effective malaria vaccine is expected to be licensed around 2012, according to the authors of an in-depth report examining the malaria product pipeline.

They warn, however, that current high levels of malaria research and development activity — 16 new malaria vaccine candidates in clinical trials and six new malaria drugs about to reach the market — is the result of scientific and technical gaps and a lack of policy co-ordination.

The report’s lead author Mary Moran, of the George Institute for International Health, Sydney, believes that improved vaccine research co-ordination and investment decisions could save more than US$20m over five years and prevent up to 3,000 unnecessary test vaccinations in African children.

“ The most tantalising finding was that these high-impact policy interventions — and the resulting savings — are well within reach if donors and developers can work together”, said Dr Moran. “We need a system to ensure that fewer and better vaccine candidates enter clinical trials in Africa.”

The authors of the report welcome the arrival of new antimalarials but point out that donors, purchasers and developing countries now face the prospect of funding large and expensive studies to determine which of the many competing products offer the best cost-benefit balance.

They estimate that additional costs for clinical development of the global malaria vaccine and drug portfolio over the next five years is likely to be around US$600m.

Malaria vaccine candidate
Promising results for a malaria vaccine candidate are published online this week in The Lancet (17 October 2007).

Researchers tested the RTS,S/AS02D vaccine in 214 infants in Mozambique using the hepatitis B vaccine EngerixB as a control. By the end of the six-month study, infants who received the malaria vaccine (at ages 10, 14 and 18 weeks) experienced a similar number of serious adverse events as infants given the control vaccine (31 compared with 30, none of which were reported as being related to vaccination).

In addition, for children vaccinated against malaria, the risk of contracting new infections was reduced (22 new cases compared with 46 new cases, adjusted vaccine efficacy estimate 65.9 per cent, 95 per cent confidence interval 42.6–79.8 per cent; P<0.0001). The researchers conclude that the vaccine is safe, well tolerated and highly immunogenic.

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