WHO vaccine preapproval opens door for China to global health market — PATH

Japanese encephalitis is a leading cause of viral disability in Asia and there is no treatment or cure. Immunization is the best means to control it. Photo by: PATH

The first-ever preapproval by the World Health Organization of a Chinese-manufactured vaccine has “opened the door” for Chinese producers to supply low-cost drugs and vaccines to developing countries, according to Steve Davis, president and CEO of PATH.

Davis hopes the approval of a low-cost, easy to administer Japanese encephalitis vaccine known as “JE SA 14-14-2” — and which PATH helped shepherd through WHO’s regulatory process — will pave the way for national vaccination campaigns in Asian countries to fight the debilitating, often fatal disease.

In an exclusive interview with Devex, he added the announcement suggests some Chinese manufacturers are more interested now than in the past in exporting health commodities to low-income countries. That could mean lower prices for global health organizations and governments, as well as new opportunities to scale up other health and vaccination campaigns.

PATH provided over the last decade technical assistance to Chinese pharmaceutical manufacturer Chengdu Institute of Biological Products to ensure the new vaccine would meet WHO’s “very, very high bar,” said Davis.

Preapproval benefits

WHO preapproval means organizations and governments that purchase health supplies through United Nations procurement channels can buy the listed vaccines and drugs without acquiring a special waiver.

The initial green light from the U.N. agency may also allow the vaccine to be made available for international initiatives like the GAVI Alliance, a global public-private partnership for the expansion of national vaccination campaigns.

Japanese encephalitis kills over 10,000 people a year, and leaves many more with severe neurological damage. The disease is untreatable, and vaccination is the only way to combat exposure.

Until now, low-income governments have struggled to achieve full vaccination coverage due to expensive and complicated multi-dose treatments, but the new Chinese-manufactured vaccine offers a single dose, low cost treatment that is much easier to administer, particularly to children, noted Davis.

China enters the global health market

Chinese pharmaceuticals have typically focused on satisfying their own country’s robust demand for health commodities, while India has produced commodities for export to developing countries.

“We’ve been talking about china’s participation in global health and development for a long time, and of course China’s always had a lot of deep South-South relations in that regard,” said Davis. “But this is really an example of china participating in a solution for a big global health and development problem outside its own borders.”

The model, he added, is now not just bilateral “but really collaborating with folks in Geneva, with us, with the Gates Foundation.”

“If we could tap into partnerships and resources and work collaboratively across sectors and countries, particularly with china coming on line more and more, it’s going to be really exciting,” said Davis.

China’s entry into the export market for low-cost health products could spell greater competition in the sector and lower prices, making the difference between a program that is donor-supported and an ongoing national vaccination campaign.

“It’s in the interests of any of the organizations that want the countries to be able to sustain these programs themselves,” Bill Savedoff, senior fellow at the Center for Global Development, told Devex.

Savedoff added: “[GAVI] is trying to encourage countries to do a better job of vaccination, but then they want the countries to take on those programs themselves. Well if the vaccines are cheaper, then the countries will do a better job sustaining them financially.”

Role for NGOs

The successful preapproval also suggests international NGOs can play an important role as technical advisors and collaborators in helping to align developing country health needs with emerging pharmaceutical producers’ interests and regulators’ standards, said Davis, who urged global health NGOs to use the same due diligence criteria as for-profit companies.

“We were reasonably relentless over a number of years,” Davis said. “We knew this was a decade long journey to build the relationships, understand the problem, size the problem, to figure out a solution … there have been a number of ‘two steps forward, one step backwards’ parts of this journey.”

A surge of national vaccination campaigns in Asian countries will require significant technical assistance from global health organizations and practitioners, as national health ministries begin to explore what the new programs will look like, and how they will be rolled out.

This first-ever preapproval of a Chinese vaccine is likely also a sign of more WHO announcements to come for China’s pharmaceutical manufacturers, who, together with producers from India and Brazil, have stepped up their safety and quality standards, noted Davis.

He sees potential opportunities for lower-cost Chinese vaccines to help fight against diseases like pneumococcus and dengue: “If it can’t be priced at a low price per unit there’s just not enough money in the system to make it available on any kind of sustainable basis.”

“Sometimes you can convince a company to give away a product or contribute an expensive product, but for any kind of sustainable procurement through a government channel … We’ve got to build this price per unit into the beginning of the equation.”

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About the author

  • Michael Igoe

    Michael Igoe is a Senior Reporter with Devex, based in Washington, D.C. He covers U.S. foreign aid, global health, climate change, and development finance. Prior to joining Devex, Michael researched water management and climate change adaptation in post-Soviet Central Asia, where he also wrote for EurasiaNet. Michael earned his bachelor's degree from Bowdoin College, where he majored in Russian, and his master’s degree from the University of Montana, where he studied international conservation and development.