Africa – Malaria Vaccine Approved

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Malaria ‘vaccine’ given the go ahead by European regulators, but some warn of difficult decisions with its implementation on the ground

European drug regulators have given the green light for a ‘Malaria vaccine’, called RTS,S or Mosquirix, set to be the first such vaccine for the mosquito-born disease,which resulted in an estimated 584,000 deaths in 2013, of which 90% were in the African region and mostly children under five.

The vaccine was developed by British GlaxoSmithKline (GSK) in partnership with the PATH Malaria Vaccine Initiative, and received funding from the Bill & Melinda Gates Foundation. It works by triggering the immune system to defend against the first stages of infection by the Plasmodium falciparum parasite after it enters the bloodstream.

Andrew Witty, GSK CEO, cited by Al-Jazeera, said the European Medicines Agency’s (EMA) positive recommendation was a further important step towards making the world’s first malaria vaccine available for young children.

“While Mosquirix on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most,” he said in a statement.

A GSK Scientist involved in the Mosquirix process since 1987, Joe Cohen, said that he had no doubt the vaccine could be significantly reduce the toll of sickness and death caused by the malaria; “I have absolutely no reservations in terms of rolling this vaccine out”, reported Al-Jazeera.

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CC, Radio Okapi

However the vaccine does not offer any final solution; trial data released in 2011 and 2012 showed that it only reduced the prevalence of malaria in babies aged 6-12 weeks by 27%, and around 46% in children aged 5-17 months.

Some medical experts and analysts have expressed concern at the complexities and potential costs of deploying this first vaccine, particularly as it only provides partial protection, making it less attractive and heightening risk.

However CEO of the GAVI Alliance Dr Seth Berkley and CEO of the Global Fund to Fight Aids, Tuberculosis and Malaria, Dr Mark Dybul, speaking in a report by the GAVI Alliance, said that the decision to supply the vaccine is not straightforward.

“None are 100% effective. So in the cold light of day, for most countries it comes down to a complex calculation based on the cost effectiveness, lives saved, illness avoided and the availability of other effective interventions”, they said

“Clinical trial data suggests that Mosquirix offers only partial protection, preventing one in three cases of clinical malaria, a relatively low success rate compared to other approved vaccines…What’s more, the clinical trials were carried out with the vaccine used in conjunction with high use of other interventions, such as long-lasting insecticide treated bed-nets and anti-malarial drugs”.

“So we don’t really know how effective the vaccine is by itself or how well it would perform outside the controlled setting of a clinical trial. The problem is…Mosquirix is about five to 10 years ahead of any other candidate malaria vaccines, and there’s no guarantee any of them will be better”, the report stated.

According to an article from the BBC, while GSK have not released a price for the vaccine, they have pledged not to make a profit. But it is the effectiveness of the vaccine, that is under the most scrutiny, as it wanes over time making a booster shot essential.

The vaccine will now move on to the World Health Organisation (WHO) who will decided how and where it will be used; facing tough decisions, considering that the vaccine was not nearly as effective as scientists hoped but also the urgency and lack of comparable alternatives in the fight against the disease.

Find out more in the Africa Research Bulletin

Health: Malaria
Political, Social  Cultural Series
Vol.52, Issue.7, Pp.20660A-20661C

Health: New Malaria Drug
Political, Social & Cultural Series
Vol.44, Issue.2, Pp.16992A–16993A

Health: Africa
Political, Social & Cultural Series
Vol.51, Issue.9, Pp.20298A–20300A

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