GlaxoSmithKline PLC’s malaria vaccine, the world’s most advanced, has cleared its final scientific hurdle, but it could still take up to a year before immunization programs begin in sub-Saharan Africa.
According to The Guardian, the world’s first malaria vaccine has been given the green light by European regulators and could protect millions of children in sub-Saharan Africa from the life-threatening disease.
The European Medicines Agency recommended RTS,S, or Mosquirix, should be licensed for use in young children in Africa who are at risk of the mosquito-borne disease. The shot has been developed by UK drugmaker GlaxoSmithKline and partly funded by the Bill and Melinda Gates Foundation. It has taken 30 years to develop the shot, at a cost of more than $565m (£364m) to date.
It will now be assessed by the World Health Organisation, which has promised to give its guidance on how and where it should be used before the end of the year. GSK will then apply to the WHO for a scientific review of the vaccine, which will be used by the UN and other agencies to help make purchasing decisions. The rollout of the vaccine, which also has to be approved by national health authorities in sub-Saharan Africa, is expected to be funded by Gavi, the vaccine alliance founded by the Gates Foundation.
According to the WHO, 627,000 deaths from malaria were reported globally in 2013, of which the vast majority (562,000) occurred in Africa, mostly among children under the age of five years (82%).
The EMA said its committee of experts “considered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very high”.
The decision had been widely expected, even though the shot offers only partial protection against malaria in children below the age of five months.
Both the EMA and GSK stressed that the vaccine would need to be used alongside other tools such as bed nets and insecticides.
Sir Andrew Witty, GSK’s chief executive, said:
“Today’s scientific opinion represents a further important step towards making available for young children the world’s first malaria vaccine. While RTS,S 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. The work doesn’t stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease.”
Dr David C. Kaslow, Vice President of Product Development at PATH said:
“Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite. PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps.”
GSK has committed to a not-for-profit price for the vaccine so that, if approved, the price would cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in research on malaria and neglected tropical diseases. The drugmaker is reportedly looking at pricing the shot at $5 (about £3.20) – the same as an insecticide-treated bed net.
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The vaccine has been developed at GSK’s labs in Belgium in collaboration with the international non-profit organisation Path.
Points to Note:
- Mosquirix is the brand name given to this malaria candidate vaccine. Its scientific name, RTS,S, reflects the composition. RTS,S also contains the AS01 adjuvant system.
- RTS,S aims to trigger the body’s immune system to defend against the Plasmodium falciparum malaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells. It is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.
- The safety and efficacy of RTS,S has been evaluated in a large-scale phase III trial, in which it was administered in three doses, one month apart, with an additional fourth dose given 18 months later. Results from this trial have consistently demonstrated that RTS,S can help to protect children against malaria in endemic countries, when used in addition to other malaria control measures such as bed nets.
- RTS,S is the most advanced malaria vaccine candidate in development globally. It was created in 1987 by scientists working at GSK laboratories. Early clinical development was done in collaboration with the Walter Reed Army Institute for Research. In January 2001, GSK and PATH, with grant monies from the Bill & Melinda Gates Foundation to PATH, entered into a public-private partnership to develop an RTS,S-based vaccine for infants and young children living in malaria-endemic regions in sub-Saharan Africa.
- GSK has invested more than $365 million to date and expects to invest a further $200 to $250 million until development is completed. Between 2001 and the end of 2014, the MVI, supported by grants from Bill & Melinda Gates Foundation, invested more than $200 million to advance the RTS,S project.
- The EMA’s CHMP opinion is a final stage in the Article 58 procedure initiated in July 2014, by which the CHMP gives a scientific opinion, in co-operation with the World Health Organization (WHO), on a medicinal product for human use that is intended exclusively for markets outside of the European Union (EU). This assessment requires medicinal products to meet the same standards as those intended for use in the EU.