资源环境科技发展态势分析平台

The COVID-19 pandemic has impacted the lives of millions of people and brought the global economy to the brink of a deep depression in merely a few months. This crisis has also spurred an unprecedented race to develop a vaccine. Currently, 30 vaccines are already in human clinical trials, eight of which were sponsored by Chinese labs. Multiple countries have also agreed to partner with Chinese labs for the last stage of human trials given that China doesn't have large scale COVID-19 infections. There seems to be little doubt, then, that China could be among the countries that first produces a successful vaccine for COVID-19. There are several issues before large-scale benefits will accrue globally. Can China produce sufficient doses for its domestic use and for other countries? Which countries are likely to benefit?

China is already one of the world's largest producers of vaccines. It produces 700 million doses annually—about 20 percent of the global vaccine production. The majority of the production, however, targets the domestic market. Chinese vaccines are still very new on the world market. China's National Regulatory Authority (NRA), the quality control regulatory system for its vaccine development and manufacture, passed assessment by the World Health Organization (WHO) less than 10 years ago. This assessment was the first step for China to receive the WHO vaccine pre-qualification (PQ).

There are three additional requirements (PDF) for the WHO PQ process: 1) the manufacturers must meet and comply with the standard Good Manufacturing Practice (GMP) requirements; 2) the manufacturers must provide publications of the clinical trials that provide evidence of vaccine efficacy in the target population; and 3) the manufacturers must provide vaccine samples to be tested at designated WHO labs (usually outside China) for independent testing.

These requirements often prove to be strenuous for the small local manufacturers that dominate the Chinese pharmaceutical sector. China has 5,300 to 7,000 local pharmaceutical manufacturers, each with a small share of the Chinese domestic market. This structure helps keep the local vaccine cost low but poses regulatory difficulties and hinders investment in capacity building aimed at the international market.

So far there are fewer than 40 vaccine producers in China that meet the GMP standards and only a handful of vaccines made in China have achieved WHO PQ and have been made available for procurement/purchasing by United Nations agencies like UNICEF and other global health organizations like the Global Alliance for Vaccine Initiative. The Japanese encephalitis vaccine that was first prequalified by the WHO in 2013 succeeded only after years of wide-ranging technical support from PATH and with funding support from the Bill and Melinda Gates Foundation.

COVID-19 may prove to be a game changer in providing an incentive for the Chinese government and vaccine manufacturers to scale up the motivation and capacity to enter the global market. Sinovac Biotech, the first private Chinese company to launch a phase III clinical trial on one COVID-19 vaccine candidate, is building a facility to manufacture up to 100 million doses annually. The international phase III trials in Brazil, UAE and other countries are also paving the way to development of an overseas market for the vaccines.

Who will benefit from Chinese vaccines? Other than the clinical trial partner countries, other low- and medium-income countries covered by the WHO's vaccine distribution plan could also benefit if China's COVID-19 vaccine receives the pre-qualification. A Chinese vaccine is less likely to come to the United States, EU and Japan, which are members of the international conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH member countries (PDF) (mostly high-income) have their own uniform regulation of pharmaceutical products usually called Stringent Regulatory Agreement (SRAs (PDF)). Most developing countries, such as India and China, use the NRA system. Such a regulatory divide probably explains why neither major European countries nor the United states have shown interest in China's COVID-19 vaccines, yet.

For a world waiting anxiously for an effective vaccine, it is very likely that China will be working with the WHO to increase the capacity of Chinese manufacturers for a world market. Chinese vaccines are still very unlikely to provide for the SRA countries, including the United States, unless significant exceptions are granted in the context of the COVID-19 pandemic.

Jennifer Bouey is a senior policy researcher and the Tang Chair in China Policy Studies at the nonprofit, nonpartisan RAND Corporation.

This commentary originally appeared on The Hill on August 12, 2020. Commentary gives RAND researchers a platform to convey insights based on their professional expertise and often on their peer-reviewed research and analysis.