Drugs/Therapy

GlaxoSmithKline Wants Approval for First Ever Malaria Vaccine

By Cheri Cheng | Update Date: Oct 08, 2013 09:19 AM EDT

Malaria is a parasitic disease that the global community has been attempting to eradicate for years. It is transferred via mosquito-bites and can kill hundreds of thousands of people every year. Due to the fact that malaria can kill so many people, with the largest group of victims from the African region, researchers have been working on a vaccine that would ideally protect at risk people. Now, GlaxoSmithKline, a drug manufacturing company from the United Kingdom, has announced that they might have created the world's first ever malaria vaccine. The company is now asking for regulatory approval.

"Many millions of malaria cases fill the wards of our hospitals," stated the lead investigator, Halidou Tinto from Burkina Faso reported by BBC News. "Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease."

According to GlaxoSmithKline, the vaccine, RTS,S, was highly effective in cutting the infection rate for children. During the trial, which involved nearly 15,500 children from seven countries, the researchers found that the vaccine was capable of nearly halving the infection rate. However, they also found that over time, the vaccine's ability to protect the body from this parasitic infection waned.

"While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive," the chief executive of GlaxoSmithKline, Sr. Andrew Witty said according to the Guardian.

For the trial, the researchers had administered the vaccine and waited 18 months before testing the vaccine's effectiveness. The researchers reported that children between the ages of five and 17 months had a 46 percent lowered risk of getting clinical malaria. The researchers also reported that for the infants between six and 12 weeks old, the risk of an infection was reduced by 27 percent.

"Based on these data, GSK now intends to submit in 2014, a regulatory application to the European Medicines Agency (EMA)," the company stated. The company hopes that if they get the EMA drug regulators to approve the application, the license will convince the World Health Organization (WHO) to promote the use of RTS,S as early as 2015.

RTS,S was created with the help of the non-profit Path Malaria Vaccine Initiative (MVI). Bill & Melinda Gate Foundation donated $200 million to the research. GlaxoSmithKline has invested $350 million on the vaccine, which the company has worked on for three decades, and intends to put another $260 million into the project before 2015. The company has announced that the vaccine will be not-for-profit.

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