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New vaccine to boost China’s drug-maker role in global health

A young boy infected with JE languishes in a hospital in the south Indian state of Andhra Pradesh
A young boy infected with JE languishes in a hospital in the south Indian state of Andhra Pradesh

As Bill Gates complained a few days ago, the media largely ignored the news that the World Health Organization has approved a new Chinese-made vaccine against a big killer, Japanese encephalitis, that afflicts the rural poor in Asia.

“That’s too bad, because there’s a powerful story here about the tremendous progress the world is making to save and improve the lives of the world’s poorest,” Gates wrote in his blog.

It is too bad, but not surprising.

The likely reason most media neglected this much-neglected disease is probably because the editors and reporters — like most Americans — have never heard of Japanese encephalitis, JE. But then again, more than a decade ago, few had ever heard of West Nile virus, WNV, either.

The two viruses, WNV and JE, are genetic cousins. They are arboviruses – meaning birds help spread them – that kill and disable people who acquire the infection through a mosquito bite.

mosquito
Flickr, Gustavo

West Nile virus was named for a region in Uganda where it was discovered many years ago. It was first seen in the U.S. in the late 1990s and has since become endemic (entrenched, in non-epidemiology lingo) here, annually killing dozens of people and sickening thousands.

Now, it’s almost a tautology to say infectious diseases don’t respect borders. And some may want to argue with the claim climate change is helping fuel the spread of mosquito-borne diseases like dengue, WNV and others. But bird-borne viruses are especially hard to contain (e.g., bird flu) and so it’s not really a scare tactic to suggest this cousin to WNV may soon end up here as well.

That would be bad. The threat to humans by WNV appears to be just chicken feed (pun intended) compared to the damage done by its much more aggressive relative JE, which regularly wreaks havoc across Asia.

One in four people infected by JE die, the CDC says.

*temp*“Our interest in this disease began when we went into the Indian state of Andhra Pradesh intending to expand Hepatitis B vaccinations,” said Julie Jacobson, who manages the Bill & Melinda Gates Foundation’s efforts against Neglected Tropical Diseases (which, as I noted above, aren’t always limited to the tropics anymore). “Indian officials told us hey, thanks, that’s great … but we have a much bigger problem with Japanese encephalitis.”

At the time, Jacobson was working for PATH on a Gates Foundation project aimed at improving a number of immunization programs for children in Andhra Pradesh (where Microsoft also has a lot of employees, and some pull with local government).

There was a JE vaccine available, she said, but it was in short supply and had some quality problems. Also, it was relatively expensive. So Jacobson and the PATH gang, supported by the Gates Foundation, did their own Asia pivot and decided to include a new effort to get a better, cheaper vaccine against this big, neglected killer.

“The officials estimate is that there are about 68,000 cases of Japanese encephalitis every year with anywhere from 20 to 30 percent of them resulting in death and at least half of the survivors left with permanent (damage) such as brain damage, seizures, loss of ability to speak or other sequelae,” said Lance Gordon, director of the neglected disease program for Gates.

“We think that’s probably an underestimate, due to lack of adequate surveillance and diagnoses,” Gordon said. Many millions of people are infected every year with billions at risk, he said, all of which contributes to the spread of the virus between animals and humans – and causing tremendous pain and suffering to the poor.

Once the Seattle gang of disease warriors decided they needed to do battle against JE, Jacobson and her team began trying to figure out how (and who) best to partner with to make a better JE vaccine.

At first, it seemed like Indian drug makers might be the most obvious choice. That didn’t work out (nobody will say why, but it usually has to do with money….). Perhaps coincident with WHO approval of China’s vaccine, Indian officials announced that they also had a newly approved JE vaccine, which is reportedly an improvement over the old one in terms of its immunogenicity but also multi-dose and more expensive than the Chinese vaccine.

Jacobson said the PATH-Gates goal was to produce a cheap and single-dose vaccine (because children in poor communities tend to miss out on secondary or tertiary boosting shots). China had a vaccine that appeared to fit the bill, but lacked many of the necessary regulatory and manufacturing standards needed to gain WHO approval for international use.

So in addition to helping with the science and clinical testing, PATH and the Gates Foundation assisted China in its efforts to finally become an internationally recognized player in the vaccine industry.

“That’s why this WHO pre-qualification for this vaccine is such a tremendous milestone,” said Kathy Neuzil, head of vaccine delivery and access for PATH. “This is a great step forward in preventing this horrible disease. But it’s also a step forward in making China a major player in low-cost and quality production of vaccines.”

Jacobson and Gordon said they can’t predict to the penny (and, well, aren’t allowed to because of proprietary concerns) the likelyt cost of the new Chinese-made vaccine. But making sure it will be inexpensive and accessible to the poorest people was a fundamental goal of this initiative at the outset and so they are confident it will be costed out in pennies rather than dollars.

“This has taken us a long time to get here,” Jacobson said. “But we got here, and it’s pretty exciting.”

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Tom Paulson

Tom Paulson is founder and lead journalist at Humanosphere. Prior to operating this online news site, he reported on science,  medicine, health policy, aid and development for the Seattle Post-Intelligencer. Contact him at tom[at]humanosphere.org or follow him on Twitter @tompaulson.