capacity three- or four-fold, which will be expensive, Glaxo R&D chief Moncef Slouai said in a panel discussion at the Gates Foundation conference.
Christian Loucq, the PATH Malaria Vaccine Initiative director, noted in an interview later in the day that the cost will hinge on the full set of clinical data from this ongoing Phase III trial. He declined speculate about what range of prices would be ideal, or acceptable, but did acknowledge that it’s a challenge to make a low-cost vaccine. He also noted that Glaxo has explored the possibility of seeking added manufacturing capacity in India, or maybe Africa. Presumably, making the drug outside of Belgium would help bring manufacturing costs down.
When it comes to “low-cost” vaccines, the bar has already been set quite low—or quite high, depending on your point of view. PATH and its global collaborators introduced a meningitis vaccine in Africa this year at the affordable cost of 50 cents per dose.
“At this point in time we don’t know what the price is going to be, but to have a repeated commitment to make the vaccine available at a price that isn’t a problem—I’m very positive about that,” Loucq says.
The GAVI Alliance, a global fund which purchases childhood vaccines for neglected diseases, will likely be the purchaser of the Glaxo malaria vaccine. And its analysis on what it’s willing to pay will depend heavily on the final outcome of the clinical studies—essentially, how effective the product really is.
“As part of all the work that will be done on this vaccine, the WHO has indicated that depending on the quality of the data, they could be in position to recommend it in 2015. For that, they will need cost-effectiveness data,” Loucq says. A cost-effectiveness analysis, he adds, factors in data about whether a booster dose of RTS,S is required, what percentage of children it protects, how long it lasts, and how it affects the need or usage of bed nets that keep mosquitos from biting people while they are sleeping at night.