After more than three decades of work and almost US$1 billion of investment, GlaxoSmithKline and its partners are ready to deploy a vaccine for malaria, the mosquito-borne disease that kills almost half a million people each year.
The vaccine, developed with the non-profit organization Path, comes at a critical time and marks a milestone in the battle against the parasite that causes malaria.
However, the injection is more pioneer than panacea: It prevented only about four in 10 malaria cases among children who received four doses in a large study.
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A pilot program is scheduled to begin this month in Africa to size up the product, which has the potential to save tens of thousands of children’s lives, the WHO said.
After declining for many years, malaria is staging a comeback. The ultimate impact might depend on securing more international funds at a time when countries are increasingly turning inward.
“Mobilizing funding for these major endeavors, which do not have a commercial opportunity, has been a challenge, and will be an even bigger challenge in the future,” Glaxo vaccines unit chief medical officer Thomas Breuer said.
The British drugmaker, which has estimated that it is spending more than US$700 million on the project, would like to “hand over the funding baton to others,” Breuer said.
The company said it is talking with partners and other groups about financing and rolling out the vaccine after the pilots.
Several hundred million US dollars more, for instance, would be needed for a manufacturing plant to expand use, according to a report published in the science journal Nature in December last year.
The vaccine brings a key new tool beyond mosquito nets, insecticides and drugs in the battle against a disease that the WHO estimated killed 435,000 people in 2017.
Children under five in Africa are particularly vulnerable, accounting for about two-thirds of all deaths.
With kids in some regions getting multiple episodes of malaria in a year, even a partially effective vaccine could have a big impact, Mary Hamel, coordinator of the program for the WHO, said in an interview.
The pilot is scheduled to start in Malawi next week, and expand to Ghana and Kenya next.
A decision to make the product more broadly available would likely be made within two to four years, Hamel said.
“A vaccine that is highly efficacious — 90 percent or so — that’s not in view at this point,” she said. “But this vaccine getting to where it is shows that a malaria vaccine can be made. It will be a pathfinder.”
The effort underscores the challenge of developing products for poorer countries that carry costs extending well beyond clinical trials and approvals, Path Malaria Vaccine Initiative director Ashley Birkett said.
Glaxo is also working on a new approach in mid-stage studies that relies on the same basic vaccine formula, but involves delaying one of the doses and reducing the amount of the antigen, Breuer said.
Billionaire philanthropist Bill Gates, cofounder of the Bill & Melinda Gates Foundation that has provided financial support for the global fight against malaria, last year said that eradicating the illness would depend on further progress in science and technology, including a technique for editing gene sequences called Crispr.
The technology is already being used to breed mosquitoes that spread sterility to deplete their numbers.
The malaria parasite has turned out to have greater genetic diversity than previously believed, compounding the challenge.
A 2017 study of more than 600 children from a village in the West African nation of Gabon found that each was infected by a slightly different strain.
Resistance to drugs and insecticides is also making efforts to eliminate the disease more difficult.
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