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| First malaria vaccine expected to be approved by European regulators | |
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| Millions of children in sub-Saharan Africa could benefit if European regulators recommend the world’s first malaria vaccine, developed by GlaxoSmithKline. | Millions of children in sub-Saharan Africa could benefit if European regulators recommend the world’s first malaria vaccine, developed by GlaxoSmithKline. |
| The shot, called RTS,S or Mosquirix and backed by the Bill and Melinda Gates Foundation, has shown partial success in protecting young children from the life-threatening disease for up to four years. About 500,000 children die from malaria every year – one child every minute – mainly in Africa. | The shot, called RTS,S or Mosquirix and backed by the Bill and Melinda Gates Foundation, has shown partial success in protecting young children from the life-threatening disease for up to four years. About 500,000 children die from malaria every year – one child every minute – mainly in Africa. |
| The European Medicines Agency’s committee for medicinal products for human use meets this week in London to decide whether to recommend the vaccine, which has been in development for 30 years and has cost more than $565m (£364m) so far. The committee of experts will publish its scientific opinion at midday on Friday. GSK submitted the vaccine for EMA review a year ago. | The European Medicines Agency’s committee for medicinal products for human use meets this week in London to decide whether to recommend the vaccine, which has been in development for 30 years and has cost more than $565m (£364m) so far. The committee of experts will publish its scientific opinion at midday on Friday. GSK submitted the vaccine for EMA review a year ago. |
| If the EMA gives the green light, as expected by many experts, the World Health Organisation will look at how the vaccine could be used alongside other tools in Africa. A WHO committee is expected to meet in October. After that, GSK would need to apply again to the WHO for a scientific review of the vaccine, which would be used by the UN and other agencies to help make vaccine purchasing decisions. | If the EMA gives the green light, as expected by many experts, the World Health Organisation will look at how the vaccine could be used alongside other tools in Africa. A WHO committee is expected to meet in October. After that, GSK would need to apply again to the WHO for a scientific review of the vaccine, which would be used by the UN and other agencies to help make vaccine 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. It is unclear how much it would cost. Reuters is reporting that it could be priced at $5 – about the same as an insecticide-treated bed net. | 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. It is unclear how much it would cost. Reuters is reporting that it could be priced at $5 – about the same as an insecticide-treated bed net. |
| GSK says it would set a price that covers its costs plus a profit margin of 5%, which would be re-invested in research on malaria and other neglected diseases. The vaccine has been developed at the drugmaker’s labs in Belgium in collaboration with the international non-profit organisation Path. The research started in the late 1980s and has been partly funded by the Gates Foundation, which has provided more than $200m in grants since 2001. GSK has invested more than $365m and expects to spend a further $200-250m until development is completed. | GSK says it would set a price that covers its costs plus a profit margin of 5%, which would be re-invested in research on malaria and other neglected diseases. The vaccine has been developed at the drugmaker’s labs in Belgium in collaboration with the international non-profit organisation Path. The research started in the late 1980s and has been partly funded by the Gates Foundation, which has provided more than $200m in grants since 2001. GSK has invested more than $365m and expects to spend a further $200-250m until development is completed. |
| The shot is about 10 years ahead of other malaria vaccines in development. It targets the deadly version of the disease that is prevalent in sub-Saharan Africa. | The shot is about 10 years ahead of other malaria vaccines in development. It targets the deadly version of the disease that is prevalent in sub-Saharan Africa. |
| The latest results, published in the Lancet medical journal in April, showed that the vaccine works better in children from the age of five months than in younger babies. This means that it cannot be added to the routine infant vaccination schedule. Another drawback is that it is a multi-dose vaccine, and its effect wanes over time so a booster shot is needed. | The latest results, published in the Lancet medical journal in April, showed that the vaccine works better in children from the age of five months than in younger babies. This means that it cannot be added to the routine infant vaccination schedule. Another drawback is that it is a multi-dose vaccine, and its effect wanes over time so a booster shot is needed. |
| Brian Greenwood, professor of clinical tropical medicine at the London School of Hygiene and Tropical Medicine, who has been involved in the project for two decades, has described the vaccine as “imperfect”, but nonetheless experts have hailed it as an important breakthrough. It was tested in 11 different African sites. | Brian Greenwood, professor of clinical tropical medicine at the London School of Hygiene and Tropical Medicine, who has been involved in the project for two decades, has described the vaccine as “imperfect”, but nonetheless experts have hailed it as an important breakthrough. It was tested in 11 different African sites. |
| There were 198m malaria cases in sub-Saharan Africa in 2013, so even a partially effective vaccine could prevent millions of those, Greenwood said. | There were 198m malaria cases in sub-Saharan Africa in 2013, so even a partially effective vaccine could prevent millions of those, Greenwood said. |