Experts say the world’s first malaria vaccine could be approved for use in 2015.
Vaccine that nearly halved cases among children aged between five and seven months could save millions in worst-hit countries
Some good news has finally arrived about the fight to eradicate malaria. A new vaccine against malaria could be introduced in the world’s worst-hit countries in 2015, after the latest trial of a treatment produced by Britain’s biggest drug company reduced the number of cases of the disease experienced by babies.
British pharmaceutical GlaxoSmithKline (GSK) announced recently that its vaccine RTS,S protected young children and infants from malaria up to 18 months after vaccination in large-scale clinical trials. RTS,S was shown to almost halve the number of malaria cases in young children (ages 5 months to 17 months at first vaccination) and to reduce by around 25 percent the malaria cases in infants.
Manufacturers GSK have now applied for regulatory approval – making this the first vaccine to reach this step.
The landscape of malaria vaccine development is littered with carcasses, with vaccines dying left, right and center – to get to this stage is very exciting” – Prof Sanjeev Krishna St George’s, University of London
Malaria is still a huge problem, especially in Africa where the vaccine trials were conducted and where 80 percent of all cases occur. Globally in 2012, there were 207 million new cases among adults and children combined, and around 627,000 deaths, mostly to children.
Although the bulk of cases occur in 14 African countries, malaria is found in 99 countries worldwide: Over 3 billion people, half of the global population, are at risk of acquiring the disease.
Sir Andrew Witty, chief executive of GSK, said the company was very encouraged by the latest results and would now apply for a regulatory license for its use in Africa under a special provision of the European Medicines Agency.
“While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive,” he said.
Inventing a malaria vaccine has involved breaking new medical ground. This is the first-ever vaccine against a parasite, said Learmouth. There are other novel vaccines in development, such as one from the US that involves injecting patients with weakened parasites, but Learmouth insisted GSK was not rushing to get a license because it feared competitors.
“We’re really not. I think the nearest vaccine is still in phase one – there is a huge long way to go. This is a very complex area. I don’t expect a competitor vaccine for a very long time,” he said.
GSK says the vaccine will be not-for-profit – but it will add 5% to the cost price which will go towards further research and development work on tropical diseases. The pharmaceutical giant has spent $350m (£218m) on the vaccine so far and expects to invest $260m more before it reaches children.
A team of 40 people will be needed to process the 1m pages of paperwork out of the many trials, which were held in seven Africa countries in different age groups. The Bill and Melinda Gates Foundation also put in about $200m.
According to the UN, countries with improved access to malaria control interventions have seen child mortality rates fall by about 20 percent. Millennium Development Goal 4 aims for a two-thirds decline in the mortality rate of children under 5 by 2015.
Twelve African countries have shown rates in line with this goal, all of them malaria-endemic countries. Some experts attribute this progress to significant expansion of ITNs and artemisin-combination therapies, the most effective malaria treatment, along with improved sanitation.
The vaccine could bolster these outcomes.
“The sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive,” said Sir Andrew Witty, the chief executive officer of GSK.
GSK and MVI have said they intend to submit an application to the European Medicines Agency next year for roll-out of the vaccine. And if all goes well, the World Health Organization could follow as early as 2015 with a recommendation for large-scale implementation.
“Africa: Malaria Vaccine Candidate Reduces Disease Over 18 Months of Follow-Up in Late-Stage Study,” All Africa.com, Oct. 7, 2013, accessed at http://allafrica.com/stories/201310080041.html, on Oct. 11, 2013.
Gabriel Demombynes and Ritva Reinikka, “Africa’s Success Story: Infant Morality Down, Africa Can End Poverty,” accessed at https://blogs.worldbank.org/africacan/africas-success-story-infant-mortality, on Oct. 23, 2013.
“Malaria Vaccine Candidate Reduces Disease Over 18 Months of Follow-up in Late-Stage Study of More Than 15,000 Infants and Young Children,” Glaxo Smith Kline press release, Oct. 8, 2013, accessed at www.gsk.com/media/press-releases/2011.html, on Dec. 6, 2013.