New malaria vaccine tentatively approved, although more work to be done

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Female Anopheles mosquitoScientists at the world s second-biggest pharmaceutical company, the UK-based Glaxo SmithKline (GSK), have been laboring to develop an effective vaccine against malaria one of the world s top killers for decades now. A recent trial in sub-Saharan African infants and toddlers found that the latest iteration of the vaccine, then called RTS,S, proved effective in babies aged 6-17 weeks at about a 27 percent reduction in potentially lethal falciparum malaria, and 46 percent protective in older children (5-17 months). (We discussed this study earlier this year). Now, The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding GlaxoSmithKline's Mosquirix, the first candidate vaccine for the prevention of malaria to reach this regulatory stage, the company announced Friday.

According to the WHO, malaria sickens around 200,000,000 worldwide, and kills someone each minute: over 500,000 dead from malaria in 2013, mostly African children and babies under 5. This toll is a remarkable achievement in and of itself, since only 10 years ago the dead were estimated to be close to one million. The improved mortality figure comes from more accessible treatments, more accurate and rapid diagnostic tests, preventive efforts focused on draining malarial mosquito breeding swamps and insecticide-treated bednets, and resurgence in many African nations of indoor residual spraying of DDT (IRS), despite the needless, ideologically-driven red-tape that has to be overcome to gain approval for such use.

GlaxoSmithKline CEO Andrew Witty said the EMA/CHMP's decision "represents a further important step towards making available for young children the world's first malaria vaccine." The company noted that it has committed to a not-for-profit price for Mosquirix so that, if approved, the price would cover the cost of manufacturing the vaccine together with a return of around 5 percent that will be reinvested in R&D for second-generation malaria vaccines, or vaccines against other neglected tropical diseases. The GAVI vaccine initiative underwritten largely by the Bill and Melinda Gates Foundation is also a participant, as is the PATH malaria vaccine initiative.

WHO spokesman Gregory Hartl said a decision on whether to back use of Mosquirix will be based on factors the EMA doesn't take into account, such as cost-effectiveness and how it compares to other preventative measures. Mosquirix was assessed for quality, safety and efficacy under a special procedure that allows the EMA to evaluate a product even if it will not be marketed in the European Union. Beyond the WHO's November recommendation, the vaccine would still have to be reviewed by national regulatory authorities in any country wishing to use it. The WHO's Hartl said this meant it is unlikely to be rolled out anywhere until at least 2017. He added that a decision from the organization is due in November. "Any financing for this vaccine must not draw resources away from scaling up bed nets, effective drugs and rapid diagnostic tests for malaria," Hartl noted.

Note that the WHO s Hartl failed to even mention insecticides in his discussion on the vaccine s possible contribution to other anti-malarial measures. That s because such chemicals, epitomized by the chemical which has saved more lives than any other, ever DDT remains an anathema to the UN and its agency WHO, thanks to the mythology generated by Rachel Carson s Silent Spring. They consider it a persistent organic pollutant and refuse to permit its routine use in IRS where its lifesaving properties would be an immense help. With this new vaccine and its subsequent improvements, it is to be hoped that the toll of malaria will continue on its downward trend.