GENEVA/LONDON (Reuters) - GlaxoSmithKline Plc is about to start final-stage clinical trials of the world’s most advanced malaria vaccine, which could reach the market within three years, the drugmaker said on Friday.
If successful, Glaxo believes its Mosquirix vaccine has the potential to save hundreds of thousands of deaths and prevent tens of millions of cases of malaria in Africa.
In what will be the largest medical experiment ever conducted in Africa, some 16,000 children and infants will be involved at 11 trial sites in seven countries.
Malaria kills around one million people a year -- most of them young children in sub-Saharan Africa.
Glaxo’s vaccine is far from perfect but it is the best yet against the mosquito-borne parasite. Earlier clinical tests suggest it is 50-55 percent effective in preventing episodes of clinical malaria.
The Malaria Vaccine Initiative, which is working with Glaxo and the Bill & Melinda Gates Foundation on the project, has set a target of getting a vaccine that is at least 50 percent effective by 2015 and one that is 80 percent effective by 2025.
“Today that dream of a malaria vaccine is just about to become a reality in a few more years,” Glaxo researcher Joe Cohen, who has worked on the project for over 20 years, told reporters.
“The pivotal Phase III registration trial will be starting within a few weeks.”
Glaxo plans to file the vaccine for regulatory approval in 2011, under a special review procedure established by the European Medicines Agency for products designed for use in the developing world. Based on normal timelines that could see Mosquirix reaching the market in 2012.
The world’s second largest drugmaker has invested more than $300 million in the vaccine to date and expects to invest at least another $100 million.
But Mosquirix is never likely to be a money-spinner.
With its target market in Africa, Glaxo will be selling the vaccine at preferential prices to international groups like the Global Alliance for Vaccines and Immunization.
“We cannot lose money but we don’t need to make money on this,” Jean Stephenne, head of Glaxo’s vaccines unit, told Reuters recently.
Malaria has proved hard for vaccine developers to beat because the parasite that causes the disease has a complex life-cycle, inside mosquitoes and humans, which helps it evade the immune system.
The tiny parasites get into the blood and reproduce in the body, causing fever and sometimes deadly brain infections.
Mosquirix -- also known as RTS,S -- works by fusing part of a protein from the parasite to the surface of a hepatitis-B viral particle, stimulating the body’s immune response. This hobbles the parasite’s ability to infect and develop in the liver, giving partial protection against the disease.