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

12/8/10Follow @xconomy

Only a few giant corporations on the planet—companies like Merck, GlaxoSmithKline, and Sanofi-Aventis—are thought to have the money, the know-how, and the infrastructure to develop new vaccines that can make a really big impact on public health.

So when a little nonprofit from Seattle called PATH is able to band together with some officials at the World Health Organization to develop a new vaccine against a deadly bug in Africa that the big guys weren’t interested in—that’s what we in the journalism business call a story. This is about going on a long and risky journey, persevering against long odds, to do something potentially really important.

This week, PATH has been featured in the New York Times, the Seattle Times, and on the KPLU website for its work in developing a new vaccine for meningitis, called MenAfriVac. On Monday, people across Burkina Faso, Mali, and Niger started getting their shots to protect them against this seasonal bug. I got a very absorbing perspective on this odyssey by talking with PATH president Chris Elias a couple weeks ago. He talked about what it takes to develop a vaccine that can protect people from this bacterial infection, at a cost of just 50 cents a dose. Much heavy lifting has been done, and much more is come, as the goal is to give this vaccine to at least 12 million kids and young adults this month.

The origins of the story trace back to 1996-97, when a particularly deadly outbreak of bacterial meningitis struck in sub-Saharan countries of Africa, Elias says. About 250,000 people got infected in the meningitis belt from Senegal to Sudan that season, and about one out of every 10 people died. Meningitis bacteria is spread from person to person via sneezing and coughing, and typically is at its worst during the hot, windy season that helps the bug spread across African countries until seasonal rains tamp it down, Elias says. Antibiotics are effective against the bacteria, but typically need to be given in the first couple days of the epidemic, because it can kill that quickly. Since these nations are among the world’s poorest, they don’t have enough public health infrastructure to effectively treat everyone in an outbreak, Elias says.

Chris Elias

Chris Elias

Around those same years of the late 1990s, a different kind of meningitis outbreak was happening in the United Kingdom. People in the UK were getting sick with a seasonal strain of what’s known as meningitis C. Given this was causing problems in a wealthy country, four companies stepped in to fill the void, developing vaccines specifically for meningitis C. These companies figured out how to take a marker on the meningitis bacteria (an antigen) and covalently attach it to a protein that would serve like a red flag for the immune system, provoking it to fight against the bacteria. This new conjugated vaccine was essentially able to eliminate the meningitis C bug from the UK. Importantly, it got the people at PATH thinking hard about whether this lesson could be applied to meningitis A, the bug that causes 85 percent of the illness in Africa. Big Pharma had at least some experience and interest in this field, as evidenced with Pfizer’s multi-billion dollar pneumococcal vaccine (Prevnar).

“When we started this project, we knew the technical risks of developing a vaccine were actually pretty low,” Elias says. “It’s not like malaria, where we are still trying to break the code.”

Suddenly, the economics of developing a vaccine singularly designed for meningitis A started looking more feasible for a nonprofit. PATH put together 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 if it could provoke an immune response. I didn’t gather from Elias how effective the vaccine truly is in protecting people who have been directly exposed to the meningitis A bacteria, and as far as I could gather, scientists don’t know how long the protective immunity may last. But the vaccine passed a key step last December when regulators in India approved the vaccine as safe for export. Another key hurdle came in July, when the WHO, through what is known as a pre-qualification process, essentially authorized it as fit for purchase by the United Nations, Elias says.

As big an undertaking as this has been, it’s no silver bullet for meningitis. As Elias says, this vaccine isn’t designed to protect against all four major strains. There are an estimated 450 million people considered at risk of infection, and it’s thought to cost $475 million to inoculate them all. There isn’t enough money for that, and it’s too logistically daunting to do all at once anyway. “It can’t happen all in one year, it will probably be over the next several years,” with the countries in most severe need getting the vaccine first, Elias says.

It will take more funding to carry on the business of delivering this vaccine to people who need it, and as Elias has often said, delivering new innovations to people who need them is often a serious stumbling block. So while the world is watching what PATH and the WHO are doing with meningitis, the work isn’t finished. Elias, in fact, is thinking it’s really just one example what he wants his organization do with a number of other vaccines.

“We think this is a model that should be replicated,” Elias says.

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