World’s first Malaria Vaccine Submitted for Approval to EMA


GlaxoSmithKline submits the first malaria vaccine for approval by the European Medicines Agency and the World Health Organization

The vaccine, named RTS,S, targets Plasmodium falciparumĀ parasite. This parasite is most commonly found in sub-Saharan, where 90% of malaria related deaths occur. Children under 5 account for 77% of the deaths.

The vaccine uses the AS01 adjuvant system, and works by preventing the parasite from infecting, maturing, and multiplying in the patient’s liver. The vaccine also aims to trigger an autoimmune response when the parasite first enters the blood stream. The vaccine was delivered in three doses each one month apart.

But, after conducting the largest clinical-study seen on the African continent (16,000 children across 7 countries) the vaccines did not perform to the standards expected. GSK however are unlikely to see blockbuster returns for this vaccine despite a huge patient population and no competitors. With just a 5% profit margin on the vaccine, and a promise to put profits back into malaria research, it’s unlikely GSK will cover their $350,000,000 investment to date, or the $200,000 million from the Bill and Melinda gates foundation.

That said, with no vaccines currently available for Malaria, any vaccine that promises some immunity for such a large and vulnerable population represents an advance in the battle against one of the world’s biggest killers.

Read the release from GSK here.

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