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Hope for Malaria Vaccine by 2015

British drug maker GlaxoSmithKline is seeking regulatory approval for the world’s first malaria vaccine after trial data showed that it had cut the number of cases in African children.

Experts say that they are optimistic about the possibility of the world’s first vaccine after the trial results.

Malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people worldwide every year.

Scientists say an effective vaccine is key to attempts to eradicate it.

The vaccine known as RTS,S was found to have almost halved the number of malaria cases in young children in the trial and to have reduced by about 25% the number of malaria cases in infants.

GlaxoSmithKline (GSK) is developing RTS,S with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation.

“Many millions of malaria cases fill the wards of our hospitals,” said Halidou Tinto, a lead investigator on the RTS,S trial from Burkina Faso.

“Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.”

The malaria trial was Africa’s largest-ever clinical trial involving almost 15,500 children in seven countries.

The findings were presented at a medical meeting in Durban, South Africa.

“Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA),” GSK said in a statement.

The company has been developing the vaccine for three decades.

The statement said that the hope now is that the Geneva-based World Health Organization (WHO) may recommend the use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its licence application.

Testing showed that 18 months after vaccination, children aged five to 17 months had a 46% reduction in the risk of clinical malaria compared to unvaccinated contemporaries.

But in infants aged six to 12 weeks at the time of vaccination, there was only a 27% reduction in risk.

A spokeswoman for GSK told the AFP news agency that the company would file its application to the EMA under a process aimed at facilitating new drugs for poorer countries.

UK politician Lynne Featherstone, International Development Minister, said: “Malaria is not just one of the world’s biggest killers of children, it also burdens health systems, hinders children’s development and puts a brake on economic growth. An effective malaria vaccine would have an enormous impact on the developing world.

“We welcome the scientific progress made by this research and look forward to seeing the full results in due course.”

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GlaxoSmithKline Malaria Vaccine Tests Show Hopeful Results

ATLANTA — The quest for the world’s first malaria vaccine appears to have taken a big step: A study in Africa shows experimental shots cut the risk of disease in young children by half.

The initial results from a final stage of vaccine testing were released Tuesday, and the vaccine’s developers called it a milestone in helping to tame one of the world’s most devastating killers.

However, the vaccine won’t be available for at least three years, as crucial further testing must be completed to see how well it works in infants and how long protection lasts. Then the vaccine must be reviewed by government agencies in Europe and in individual African countries.

“We still have a way to go,” Tsiri Agbenyega, lead researcher for the African study, said in a conference call with reporters.

The early results show the vaccine is only about 50 percent effective, significantly lower than the protection seen in more common vaccines. But some experts said it’s a vast improvement over the current situation, and could still save hundreds of thousands of lives.

Globally, malaria kills nearly a million people annually. More than 90 percent of them live in Africa, and most are young children and pregnant women.

Scientists have been trying for decades to develop a malaria vaccine and the one tested – developed by GlaxoSmithKline – is furthest along. Without a vaccine, efforts have concentrated on malaria drugs and other ways to prevent infection such as mosquito bed netting and insecticides.

The new vaccine targets a malaria parasite found in sub-Saharan Africa. Malaria spreads through mosquitoes, which bite people and flush malaria parasites into the bloodstream. The parasites cause bouts of high fever and can end in fatal organ failure.

In the United States, malaria has been eradicated since the early 1950s. Only about 1,500 cases are diagnosed in the U.S. each year, most of them travelers or immigrants from South Asia, sub-Saharan Africa or other places where malaria commonly spreads.

The new study – still under way – began in 2009 and involves more than 15,000 children in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.

The results focus on about 6,000 children ages 5 to 17 months. A year after three doses, the vaccinated children had about half as many cases of malaria as a group that didn’t get the vaccine.

Meanwhile, experts are waiting for results from research in a younger group – infants ages 6 to 12 weeks. That’s the age when children in sub-Saharan Africa are vaccinated against other diseases. Earlier vaccination also affords earlier protection.

Although there are an array of vaccines against viruses and bacteria, there has never been an effective vaccine against a parasite, which is a more complicated organism. Adding to the complexity is there are five species of malaria parasites – the new vaccine is designed specifically to protect against the deadliest one, which is common in sub-Saharan Africa.

GlaxoSmithKline paid for the study along with the PATH Malaria Vaccine Initiative, a program funded by the Bill & Melinda Gates Foundation. The results were released Tuesday at a malaria conference in Seattle and published by the New England Journal of Medicine.

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