Experts Welcome World’s First Malaria Vaccine

GlaxoSmithKline (GSK) 

From test trial, the world’s first vaccine to tackle malaria, a disease that threatens the life of about 3.3 billion worldwide, will soon be available in commercial quantity for the treatment of the disease.

British drug maker, GlaxoSmithKline (GSK), is seeking regulatory approval to produce the malaria vaccine for sale, after trial data showed that it had cut the number of cases in African children.

Experts Tuesday welcomed the bid, saying they are optimistic about the possibility of the world's first vaccine being deployed to tame malaria, after the trial results.

According to the World Health Organisation (WHO), malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people worldwide yearly, with an estimated 219 million cases of the disease reported in 2010, causing an estimated 660,000 deaths.

But scientists said an effective vaccine was crucial to attempts to eradicate the disease instead of the drug regimen being used now to fight 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 per cent the number of malaria cases in infants.

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

Researchers found out that the vaccine, which is being developed in the US, protected 12 out of 15 patients from the disease, when given in high doses.
The method is unusual because it involves injecting live but weakened malaria-causing parasites directly into patients to trigger immunity.

"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,” Tinto added.

The malaria trial was Africa's largest-ever clinical exercise 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)," the pharmaceutical company said in a statement.

The statement said the hope now is that 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 per cent 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 per cent reduction in risk.

A spokeswoman for GSK told the AFP 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."

When THISDAY yesterday sought the views of the National Coordinator, National Malaria Control Programme, Abuja, Dr. Nnenna Ezeigwe, on the bid to produce the vaccine for sale, she said she was attending a meeting in Durban.
Without providing further insights, Ezeigwe sent in a short message, saying she would comment later.

However, a pediatrician with a general hospital in Lagos, who craved anonymity, said the development would have a salutary effect because of the burden of malaria disease on the continent.

According to him, the disease ranks highest in claiming the lives of children under-five and a vaccine to check the death toll from malaria would be highly appreciated.
Also speaking on the vaccine, Dr. Olumuyiwa Odusote of the Lagos General Hospital, described the development as cheery.

However, Odusote stated that all precautionary measures and checks would have to be done by regulatory authorities to ensure that when the vaccine is eventually released into the market, it would be efficacious.

He said malaria remains the leading cause of maternal mortality and death of children aged under five years in the country.

He added that if a vaccine that could build up people's immunity against malaria attacks is finally released, "it will be very interesting indeed."