GSK Malaria Vaccine Stands Out at Gates Foundation Confab, But Cost Still the Big Question

The buzz at the Bill & Melinda Gates Foundation’s malaria conference yesterday was all about clinical trial results from a new vaccine the foundation developed with pharma giant GlaxoSmithKline. But there’s a big question about how much this vaccine will cost, and nobody is willing to offer specifics about that yet.

To recap, here’s what got people excited. The vaccine, known as “RTS,S,” showed it protected about half of African children aged 5-17 months from getting the disease, with minimal safety problems or side effects, according to findings published in the New England Journal of Medicine. The analysis was done on about 6,000 children, who were followed for 12 months after being vaccinated. The data, from the third and final phase of clinical trials, essentially confirmed what scientists saw in more preliminary studies. The full trial is expected to run through 2013, and once a 30-month follow-up analysis is complete, the hope is that the vaccine could be made available for sale in Africa in 2015, says Christian Loucq, the director of the PATH Malaria Vaccine Initiative, a Gates-funded initiative that is co-developing the vaccine with Glaxo.

It’s clearly a bit of good news for the field of malaria. The disease, which was wiped out thanks to the widespread use of the insecticide DDT in many parts of the world in the mid-20th century, made a roaring comeback as the malaria parasites evolved, killing as many as 1 million people a year worldwide by the early 2000s. The death toll has dropped in recent years by about 20 percent, to an estimated 781,000 in 2009, according to World Health Organization (WHO) statistics cited in an AFP story.

No one has ever successfully developed a vaccine against this infectious disease, and the ability to disseminate one will depend heavily on price. Glaxo CEO Andrew Witty repeated yesterday that the company plans to sell the vaccine at the same cost it takes to manufacture the product, plus a 5 percent markup, which will be plowed back into development of next-generation vaccines for malaria and other bugs. Bill Gates himself, in a keynote, commended the company for its commitment to a “low-cost” vaccine. But exactly how much it will cost to produce such a vaccine for some of the world’s poorest people, and will it be priced low enough so that it can really reach the tens of millions of children who need it?

Melinda Gates, center, at blogger roundtable in Seattle. Gates Foundation program officer Jessica Milman, right.

That’s where things get more vague, and more sensitive. I posed the question to Melinda Gates yesterday in a briefing with bloggers, and she deflected it to an aide sitting next to her—Jessica Milman, a senior program officer at the Gates Foundation. Here’s the exchange:

Xconomy: We heard Bill mention this morning that GlaxoSmithKline is committed to a low cost for the RTS,S vaccine. How low is low? And what is a good price for a vaccine that is 50 percent protective?

Jessica Milman: All we can really go on is what Andrew Witty has been saying. He has said cost will not be a barrier for people who need it most. And he has been on the record multiple times saying it will be the cost of manufacturing plus a 5 percent margin, all of which he plans to put back into research for neglected diseases.

X: But where would you like to see the price at, so it can reach the broadest number of people?

JM: The issue of cost has to be built into the efficacy, and the coverage that we think we’ll be able to achieve. Right now, everything is in motion, as we collect the rest of the data and we get a better sense of what will be the most appropriate cost.

Followers of the pharma industry know quite well how hard it is for any company to make a commitment like Witty’s. The malaria vaccine effort so far has cost $300 million over the past decade, and GlaxoSmithKline estimates it will have to invest another $100 million to $150 million to complete the project. The company is developing capacity to make 30 million doses of the vaccine at a factory in Belgium now, three to four years before the vaccine might be widely available, so that it can meet the demand it anticipates based on the current rate of effectiveness. It’s possible the company may need to boost 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.

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