- Title: GSK-MALARIA/VACCINE World's first malaria vaccine gets regulatory go-ahead
- Date: 24th July 2015
- Summary: NAIROBI, KENYA (FILE) (ORIGINALLY 4:3) (REUTERS) VARIOUS OF SCIENTISTS RESEARCHING MALARIA WITH LIVE MOSQUITOES BLOODIED MESH WITH MOSQUITOES MOSQUITOES ON SKIN
- Embargoed: 8th August 2015 13:00
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- Location: Switzerland
- Country: Switzerland
- Topics: General
- Reuters ID: LVA1XM0XY8EVMMPWVXX440L2NGFH
- Aspect Ratio: 16:9
- Story Text: EDITORS PLEASE NOTE THIS EDIT CONTAINS 4:3 MATERIAL
The world's first malaria vaccine, called Mosquirix, got a green light on Friday (July 24) from European drugs regulators.
Mosquirix, also known as RTS,S, was assessed for quality, safety and efficacy under a special procedure that allows the European Medicines Agency (EMA) to evaluate a product even if it will not be marketed in the European Union.
Malaria is one of the biggest killers of children in the world, claiming the life of one child every minute. It infects around 200 million people a year and killed an estimated 584,000 people in 2013, the vast majority of them babies in sub-Saharan Africa.
Mosquirix was developed by British drugmaker GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative.
It would be the first licensed human vaccine against a parasitic disease, as GSK's Chief Executive Officer Andrew Witty explained on Friday.
"This is the world's first vaccine against any parasite. It's not just the first vaccine against malaria. It's never been done before and as recently as 10 years ago well informed scientific opinion would say that this was an impossible mission," he said.
Expectations that Mosquirix could be a final answer to wiping out malaria were dampened when trial data released in 2011 and 2012 showed it reduced episodes of malaria in babies aged 6-12 weeks by only 27 percent, and by around 46 percent in children aged 5-17 months.
For GSK those statistics are not a legitimate concern.
"Nobody is claiming this is perfection. In fact there is no vaccine in the world which is 100 percent protective. This vaccine offers something like 25-50 percent protection depending on the age group, in addition to the use of bed nets," said Witty.
Global health experts have long hoped scientists would be able to develop an effective malaria vaccine, and researchers at GSK have been working on RTS,S for 30 years. The shot also contains an adjuvant, or booster, made by U.S. biotech company Agenus.
Professor Brian Greenwood of the London School of Hygiene and Tropical Medicine explained why a vaccine for malaria had proved to be such a challenge.
"The malaria parasite is a difficult bug. I mean it has . . . it's a very complicated . . . it has different stages: it lives in a mosquito, it lives for part of its time in humans in the liver and in the blood, it has about 5000 genes, it makes lots of different proteins, it's lived with us for a long time and learnt how to evade the immune system that naturally happens when you get an infection. And so it really has proved very, very difficult to develop a vaccine against the malaria parasite and any other of the parasites," he said.
Some malaria specialists have expressed concern that the complexities and potential costs of deploying this first vaccine when it provides only partial protection, make it less attractive and more risky.
The vaccine faces hurdles before being rolled out in Africa, including winning agreement from governments and other funders that it is worth using, since it offers only partial protection.
The EMA recommendation is that the shot should nevertheless be used in babies in the full age range covered in the trials, from six weeks to 17 months.
Save the Children's Simon Wright welcomed the development but said questions remain.
"Now this vaccine today is really welcome. It is starting to show an effect for the first time. A lot of questions about it though. How much is it going to be cost? How is it going to be delivered? And how long will it last?" he asked.
Mosquirix, which was part-funded by the Bill & Melinda Gates Foundation, will now be assessed by the World Health Organization (WHO), which said on Friday it would begin a review in October on when and where it could be used. The WHO aims to make a recommendation by November.
WHO spokesman, Gregory Hartl, called the vaccine a "big step forward" and welcomed the opinion of the EMA.
"We will look at the vaccine from the point of view of public health, and what we will need to do is look at issues such as the feasibility of using this vaccine in field situations in developing countries, we need to look at its affordability and its cost effectiveness. We will also need to look at the public health value of the vaccine in relation to other malaria control measures," Hartl added.
Beyond the WHO's November recommendation, Mosquirix 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.
GSK has promised it will make no profit from Mosquirix, pricing it at the cost of manufacture plus a 5 percent margin, which it will reinvest in research on malaria and other neglected tropical diseases.
Sources involved in planning for Mosquirix's potential future use said they've been advised to work with a price tag of around $5 per dose, which would bring the cost of a recommended four-dose immunization to $20. - Copyright Holder: FILE REUTERS (CAN SELL)
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