GlaxoSmithKline has become the first to seek regulatory approval for a malaria vaccine from the European Medicines Agency (EMA). Today, the results of their phase III trials have been published in PLOS Medicine, and while not completely effective, the results are still pretty promising.

The vaccine in question is called RTS,S/AS01, which consists of a protein found on the malaria sporozoite fused with a protein found on Hepatitis B. Development of this vaccine has been in the works for decades, and has involved time and monetary commitments from many different institutes including the Bill & Melinda Gates Foundation (see graphic for full history).

Promising results from possible first malaria vaccine


In this final, large test of the vaccine, 6,537 infants and 8,923 children received the RTS,S/AS01 vaccine or a control vaccine for unrelated diseases. (As an aside, yes, it sucks that not every child gets the vaccine, but it's an important part of determining whether new vaccines/medications works). After 18 months, the investigators revisisted the children and looked at rates of malaria infection. They saw a 46% drop in malaria cases in children, and a less dramatic drop of 27% in infants.

The vaccine isn't without some pitfalls. Children and infants who received the vaccine had an increased chance of developing meningitis (although its worth noting that the rates are still very low). Also, the efficacy of the vaccine dropped with time, highlighting the importance of boosters.

Whether this vaccine will get approval, and therefore become the first malaria vaccine, still remains to be seen. Even with partial protection, it could still be very useful in the fight against malaria, especially when combined with other malaria/mosquito control efforts.

As for how much the vaccine would cost if approved? According to GSK, they would sell the vaccine at a 5% profit. As for what dollar amount that will mean for a product that cost $600 million+ to develop? We shall see...