SHANGHAI – Marking a turning point for Chinese biotechnology, a company from Sichuan province – Chengdu Institute of Biological Products Co. Ltd. (CIBP) – has earned coveted pre-qualification status from the World Health Organization (WHO) for its Japanese encephalitis (JE) vaccine. It’s the first time a Chinese vaccine maker has earned a WHO seal of approval, which opens up markets worldwide.

The availability of the vaccine is good news for 4 billion people who live in JE endemic areas, mostly found in Southeast Asia. Children can contract the deadly virus from mosquito bites.

The SA 14-14-2 live attenuated JE vaccine was first developed in China more than 20 years ago. The pre-qualified version is manufactured at a new purpose-built plant in Chengdu and run by CIBP, a subsidiary of China National Biotec Group (CNBG), the largest vaccine manufacturer in the country and one of the largest in the world.

Prequalification, an endorsement that a drug meets international standards of quality, safety and efficacy, is a requirement for a drug to be procured by UN agencies or to obtain vaccine financing for low-income countries. The vaccine is available to public bidders for about 30 cents per dose.

“We have reached two major milestones today. In addition to achieving WHO prequalification of our JE vaccine, we are proud to be the first Chinese manufacturer to produce a WHO-prequalified vaccine,” said Yang Xiaoming, CEO of CNBG. “With PATH’s support and WHO’s prequalification, we’re proud to bring China onto the global stage as an important vaccine supplier serving GAVI-eligible countries.”

PATH is an international nonprofit organization focused on health care innovation. The Global Alliance for Vaccines and Immunisation (GAVI) secures funding for countries to acquire vaccines.

CIBP’s achievement comes at the end of an eight-year cooperation project between PATH and CIBC and CNBG that included $39 million in funding from the Bill and Melinda Gates Foundation.

The partnership was both positive and multifaceted, Kathleen Neuzil, director of PATH’s Vaccine Access and Delivery Program, told BioWorld Today. It is “a great story of partnership.”

“Prequalification means that all communities in JE regions will have access to a safe, affordable vaccine,” Neuzil said. “We’ll now work with our global health and in-country partners to accelerate the delivery of this vaccine to children in low-resource settings who are most vulnerable to the disease and its severe consequences.”

It all started in India after a deadly outbreak of JE. PATH was requested to find a vaccine. The group discovered China had been making a JE vaccine that was part of the country’s national immunization program since 2007. While the depth of experience was there, China had some way to go to be ready for international markets.

Making the Grade

The project involved several steps: bringing in manufacturing quality control systems tailored for a complex biological where contamination can take place, conducting five clinical trials on the vaccine produced at the plant and setting up a pharmacovigilance program to report adverse events once the vaccine is administered.

PATH also improved the surveillance and understanding of JE’s disease burden, which has been tough to track. The disease is endemic throughout Asia and high-risk areas have been identified where the vaccination program can begin first.

JE, also known as brain fever, is the leading cause of viral neurological disease and disability in Asia. The disease is easily transferred from animals to humans by mosquitoes. There are nearly 70,000 cases reported each year in the region with 10,000 to 15,000 deaths, but these numbers may underrepresent the situation since the rural poor are the most highly affected. Many children that survive suffer neurological damage such as paralysis, recurrent seizures or the inability to speak.

To be fully effective, a JE immunization program requires 100 percent vaccination. The number of doses that countries will need is unknown since some countries will play catch up and immunize children from 9 months up to 15 years old before a universal program can get under way.

Midway through the JE vaccine project, there was still a major roadblock to overcome. For a pre-qualification application to be made, a country’s regulatory body has to first show that it meets international standards.

In 2011, China’s State Food and Drug Administration (now the CFDA) was granted approval by the WHO. With this in place, the SFDA’s regulatory capability was validated. Chinese vaccine makers got the impetus to apply for prequalification (PQ). A number of factories are now on their way to gaining PQ over the next few years.

The CFDA has said China has 36 vaccine makers producing 1 billion doses a year.

For CIBC, the road to the PQ has been long. The actual prequalification process required an extensive review by WHO officials and numerous site visits. CIBC agreed to ongoing WHO monitoring.

But there are a number of benefits to the PQ. CIBC now has access to worldwide markets. UN agencies such as UNICEF and the GAVI can only procure WHO pre-qualified vaccines.

Another benefit is harder to peg but just as important. The institutional knowledge CIBC has gained will be passed onto the parent company CNBG. As a media spokesperson outlined: “Based on such a leading platform, it could be predicted that more vaccine products from CNBG will obtain WHO prequalification.”

Considering China’s sizeable capacity to manufacture vaccines coupled with the PQ endorsement, China could change the way vaccines are made, delivered and priced for the developing world.

“This is a once-in-a-decade announcement. I look forward to coming to China to celebrate with them,” Neuzil added.