China looks to a new industry: global vaccines

BEIJING — Last month the World Health Organization issued an obscure ruling with the potential to transform China’s vaccine industry – and with it, the health of the world’s poorest children.

China National Biotec Group (CNBG), a Beijing-based firm, became the first-ever Chinese vaccine manufacturer to receive WHO “pre-qualification,” a global seal of approval for quality, safety and efficacy. This designation allows CNBG to sell its vaccine against Japanese encephalitis to international agencies that purchase vaccines for people in low-income countries.

The milestone represents a leap forward for control of a mosquito-borne disease that kills 15,000 children each year and causes permanent brain damage in thousands more. But the vaccine has the potential to be an even bigger leap for Chinese industry.

With multiple firms now in discussion with WHO on other vaccines, including against polio and major childhood killers such as rotavirus and pneumococcal disease, China is exploring a new role as a vaccine supplier to the world.

This is a development that everyone who cares about global health should cheer and help support.

China’s ability to be a positive force for reducing childhood mortality and improving health in poor countries has never been greater. It will take new commitments from both within and outside China for that ability to be fully realized.

China boasts the largest vaccine manufacturing capacity of any country in the world. Approximately 40 companies produce more than 1 billion vaccine doses annually, and they have experience developing vaccines that are practical for low-income settings.

Yet to date, China’s vaccine makers have served primarily one customer: China. Lacking a global stamp of quality, firms have been unable to compete for giant multi-country tenders issued by agencies such as UNICEF and the GAVI Alliance. To the extent that Chinese firms have sold vaccines to other countries at all, it has been limited to a small number of bilateral contracts.

The impact of China’s further entry into the global vaccine market would be enormous. New suppliers from China would increase competition and drive down vaccine prices, much as India’s manufacturers did during the past decade. That helped fuel a global immunization push that has resulted in more than 80 percent of children worldwide receiving essential vaccines.

If Chinese industry is to one day accelerate global efforts to reach more children with vaccines, major obstacles will need to be overcome. Time, money and technical assistance must be invested for more Chinese vaccine companies to bring their plants and processes up to international standards.

As a first step, Chinese vaccine firms must address cultural challenges that have prevented them from accessing the international market. Chief among these is that English is the working language of WHO. This gives a huge advantage to Indian manufacturers, which currently produce 70 percent of the vaccines procured by the United Nations.

International partners can provide critical support. WHO already provides training for Chinese companies to navigate inspections, audits and procedures in the prequalification process, and efforts like this should continue and expand. Nonprofit groups have a role too. For example, it was a U.S.-based group, PATH, that first identified a role for CNBG’s encephalitis vaccine in low-income countries, and worked for more than a decade with CNBG to obtain the seal of approval.

Chinese pharmaceutical and biotechnology companies themselves can adopt more of a global outlook. They can build English-language capacity and bring in executives and scientists who aspire to make a difference abroad. Chinese firms have already begun embracing the international market for other health technologies, such as those for HIV prevention and maternal health.

Perhaps the greatest way Chinese vaccine manufacturers can boost health in poor countries is by agreeing to the international norm of pricing vaccines based on a country’s income level. CNBG is to be commended for pricing the WHO-endorsed encephalitis vaccine in this way. The lowest price for the vaccine, approximately 30 cents per dose, is reserved for the poorest countries.

Many children in poor countries receive vaccines with the assistance of international donors, and low prices allow aid budgets to go as far as possible. Access to low prices from manufacturers in China and elsewhere can also enable poor countries to shoulder some of the cost of their immunization programs themselves, a step toward full ownership of those programs.

We all have an interest in China’s vaccine industry embracing the highest standards of quality, safety and efficacy. If China chooses to use its domestic vaccine manufacturing heft to meet global needs, it can benefit both China and the world’s poorest countries.

Lucy Chen is Executive Deputy Director, Institute for Global Health, Peking University.