One of the world’s most prestigious medical journals – the Lancet – has announced that the first-ever malaria vaccine has successfully passed the final trials and is now awaiting approval by intergovernmental authorities.
The vaccine, developed through a partnership between the PATH Malaria Vaccine Initiative in Washington, DC, and the pharmaceutical company GlaxoSmithKline (GSK), has been in the making for two decades and cost around 500 million dollars so far.
Developers of the vaccine are hopeful it will be approved for use by the end of this year, although it could take longer than that before it clears regulatory hurdles in individual African countries.
Even though the efficacy of RTS,S leaves much to be desired, even modest levels of protection may lead to a significant drop in malaria-related deaths. According to estimations, this devastating condition currently kills around 1300 children per day in sub-Saharan Africa alone.
“Given that there were an estimated 198 million malaria cases in 2013, this level of efficacy potentially translates into millions of cases of malaria in children being prevented,” says lead author Brian Greenwood of the London School of Hygiene and Tropical Medicine.
In the study, 15.459 children in seven African countries where malaria is common were divided into two groups – babies aged 6 to 12 weeks and older children aged 5 to 17 months.
Both groups received three jabs of the vaccine within two months, and some also received a booster shot 18 months later.
The results show that RTS,S works best in older children who received the additional booster dose, reducing cases over four years by 36%. Without the bonus shot, this figure fell to 28%.
In the second group, incidence was decreased by 26% in booster shot recipients, compared with 18% in non-recipients. The booster also provided better protection against severe malaria in the older children, but not in the babies, which might be explained by differences in immune function and interference with other vaccines.
The European Medicines Agency (EMA) is expected to announce its decision on September, after which – as soon as a month later – a special WHO panel will decide whether to make the RTS,S jabs routine in Africa.
Vasee Moorthy of the WHO’s Vaccines Department in Geneva, Switzerland, warns that even if the vaccine is approved, it should not be funded at the expense of other effective measures against malaria, such as insecticide-treated bed nets that protect sleeping children from the parasite-carrying mosquitoes.
“Any possible use of this vaccine in the future must take place in the context of the WHO’s recommended core malaria-control measures, prioritising universal access to long-lasting insecticidal nets and prompt access to diagnosis and treatment with artemisinin-combination therapies,” Moorthy told New Scientist.