Watch Out Big Pharma: PATH, WHO Show that Nonprofits Can Develop New Meningitis Vaccine

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a joint proposal with the World Health Organization and submitted it to the Bill & Melinda Gates Foundation. The idea was to take 10 years and $70 million from the Gates Foundation, and invest the time and money in developing, testing, and ultimately introducing a new vaccine. That’s a lot less than the hundreds of millions of dollars it often takes to develop a new vaccine used in wealthy countries.

PATH brought its expertise in technology development to the table, while WHO had a lot of experience working in the meningitis belt of Africa, Elias says.

An important early decision was made on what kind of vaccine to develop. The technical risk was lower in going after a vaccine for just one strain of meningitis, as opposed to trying to make a “quadravalent” vaccine against all four major strains. “We felt it was important to move quickly to get a vaccine against most of the problem, rather than do a more complex version that takes longer,” Elias says.

Once the contract was in hand, PATH and the WHO (under the banner of the Meningitis Vaccine Project) talked to health officials in Africa. “We asked them for advice on how to think about this. They said the only thing worse than not having a vaccine was to have a vaccine they couldn’t afford,” Elias says.

The goal was set to develop a vaccine of 50 cents a dose or less. And health officials hoped to reach everyone under the age of 30, who tend not to have as much natural immunity against the bug. WHO convened some consultants with experience from the vaccine industry to see if this price was feasible. The word was that if they used the least expensive ingredients and the most efficient process for conjugating polysaccharide antigens (which don’t provoke much immune response) with carrier proteins that do provoke an immune response, then it was feasible.

Feasible as it may have been, the big vaccine makers weren’t interested. They would have to convert their facilities from using other carrier proteins for their other vaccines—which would be a difficult process. PATH’s Elias, never one to cast a stone against his industry partners, described this exchange diplomatically. “They were making reasonable business decisions on opportunity cost,” Elias says.

PATH and the WHO found a willing partner in the Serum Institute of India, the world’s largest producer of measles and diphtheria, pertussis (whooping cough) and tetanus vaccines. The Serum Institute, founded in 1966 according to its website, makes half of the vaccines that UNICEF purchases, Elias says. “They make high-volume, high-quality vaccines. They are making basic vaccines for kids in poor countries,” Elias says.

So, true to form for PATH, partnerships were the key. It found one partner in the Netherlands—Synco Bio Partners—to make the essential polysaccharide ingredient for the meningitis A vaccine. The Serum Institute was asked to make the tetanus toxoid to make the vaccine more potent. Then the vaccine developers licensed a technology invented at the U.S. Food and Drug Administration’s labs in Bethesda, MD for conjugating vaccine components together. The story required lots of actors in Europe, India, and the U.S.

Once the package was put together in a vial, it was time to see if it worked. The initial step back in 2005 was to see in a clinical trial if the vaccine was safe. Then, researchers wanted to see … Next Page »

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