A malaria vaccine 30 years in the making by British drug maker GlaxoSmithKline is the first approved by European regulators for licensing in Africa, where it can be used on babies at risk from the mosquito-borne disease, AlJazeera reports.
Malaria killed 584,000 people in 2013, mostly in sub-Saharan Africa, and more than 80 percent of victims were under the age of 5.
An injection of the vaccine Mosquirix, or RTS,S, will be the first licensed human vaccine against a parasitic disease and could help prevent millions of cases of malaria in countries that use it, according to the report.
“This is a hugely significant moment,” said Ripley Ballou, head of research at GlaxoSmithKline vaccines, in a BBC report. “I’ve been working on this vaccine for 30 years and this is a dream come true.”
The company hasn’t said how much the vaccine will cost, but promised it won’t profit from it, according to BBC.
The vaccine was developed by GlaxoSmithKline in partnership with the U.S.-based PATH Malaria Vaccine Initiative and Bill & Melinda Gates Foundation, AlJazeera reports
Clinical trials of the malarial vaccine in 2011 and 2012 showed only limited success in protecting against malaria.
The shot reduced episodes of malaria in babies aged 6-to-12 weeks by 27 percent, and by around 46 percent in children aged 5-17 months.
However the European Medicines Agency recommended the drug for licensing anyway. That body’s recommendations are usually endorsed by the European Commission within a couple of months, according to AlJazeera.
“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,” said Andrew Witty, CEO of GlaxoSmithKline, in a prepared statement.
The European Medicines Agency recommends that the shot be licensed for use in babies in the full age range covered in clinical trials – from 6 weeks to 17 months.
Some malaria experts are concerned that costs and complexities of deploying this first vaccine when it only provides partial protection make it risky and unattractive.
However, the vaccine will still save lives of African children, said Joe Cohen, a GlaxoSmithKline scientist who led the development of Mosquirix since 1987.
“I have absolutely no reservations in terms of rolling this vaccine out,” Cohen told Reuters. “It will have an enormously significant public health impact.”
The next step is for the vaccine to be assessed by the World Health Organisation, which said it will give guidance on when and where it should be used before the end of 2015, AlJazeera reports.
An estimated 200 million people are infected with malaria each year, GoodMagazine reports. It’s one of the deadliest creatures on earth.
The European Medicines Agency’s approval removes a major hurdle on the drug’s way to helping people.
GlaxoSmithKline promised that Mosquirix will be non-profit, GoodMagazine reports. Injections will be priced at production cost plus a small mark-up, which will be used to fund more research. The cost is estimated to be around $5 per injection, in a series of four, according to Reuters.
Clinical trials were conducted in seven African countries including Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania, according to PATH.
Source: AFK Insider