WHO’s Sinopharm approval opens the door to distributing Chinese vaccines abroad

In addition to dealing with spikes in India and Brazil, countries that border China should also receive priority for Chinese vaccines
Being active in Covax and other multilateral channels can help overcome geopolitical hurdles and ensure access to more foreign markets in the future

Zha Daojiong

Published: 3:30am, 13 May 2021

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May 7, 2021 will be seen as a milestone for China’s vaccine industry in the history of public health. That was the date the World Health Organization added a vaccine made by China’s Sinopharm to its emergency use listing for the Covid-19 pandemic.

The development is historic given that the Sinopharm product is the first solely from a developing country to be included in a globally recommended treatment mechanism for dealing with an ongoing infectious disease. The five products already on the emergency use listing are made by companies in developed countries, except for one done as a collaboration with the Serum Institute of India, a company of global renown.

By way of contrast, Sinopharm only emerged in the international vaccines market in 2013, when it was pre-qualified to supply a product against a strain of encephalitis.

Before gaining emergency-use status, the Chinese vaccine was authorised for use in China and 40 other countries. Along the way, there were questions about the availability and quality of data, including in internationally recognised science publications such as Nature.

Yet, the global vaccine industry operates in a hierarchy between products approved by stringent regulatory authorities – those that set standards for the rest of the world – and those approved by national regulatory authorities. China’s vaccine approval authority is in the national category.

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For a vaccine approved by the Chinese regulatory authority, examination of its data by the WHO’s Strategic Advisory Group of Experts on Immunization (Sage) is equivalent to review by a stringent regulatory authority.

Sage experts conducted on-site inspections at the production facility in China before reaching their decision. The emergency use listing is therefore a reference to national regulators that a product is safe and effective for adoption.

With this status, the Chinese product is one step closer to inclusion in the WHO-supported Covax Facility, launched with Gave, the Vaccine Alliance to provide Covid-19 vaccines primarily for low- and lower-middle-income countries. China joined Covax in October 2020, and in February it pledged to provide 10 million doses for distribution.

China should now negotiate with Covax, with the aim of fast delivery of pledged doses to countries in need. Sudden spikes like the ones in India and Brazil in recent weeks require immediate attention.

However, countries that border China should also receive priority attention. China can and should consider earmarking some of its supplies to Covax for its neighbours.

With a Chinese-made product now included in the emergency use listing, China may receive more requests from countries, as their health regulatory authorities will find the WHO authorisation a useful reference. However, Beijing must resist the temptation to see the number of countries adopting its vaccines as a primary marker of achievement.

For one thing, countries that are “vaccine deserts” are likely to have poor basic health infrastructure for inoculation, post-injection surveillance and related data gathering. China should therefore find a balance between satisfying needs and protecting the prospects of its vaccine industry by assessing contributions to its post-inoculation assessments.

In this context, working with Covax is in China’s best interests. The relative success in containing the spread of the coronavirus within China made it necessary for Chinese vaccine developers to conduct second- and third-phase clinical trials in a few foreign countries. That collaboration was essential for the product to be made and be considered acceptable abroad.

With the emergency use listing granted, multilateral collaboration is essential for China’s vaccine industry. Covax as a distribution channel can help enhance confidence in the reliability of product data, including after inoculation.

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The reality is that the Sinopharm vaccine is subject to “continuous evaluation”, as noted by Arnaud Didierlaurent, a professor at the University of Geneva’s medical school and chair of the WHO’s technical advisory group. As a matter of practicality, it saves money and effort for a developer if it can make use of data collection through a multilateral mechanism.

It is equally important for China’s vaccine industry to note that regulatory authorities in the European Union, Britain and the United States have yet to examine the Sinopharm product. There could be many possible reasons for this, including that Sinopharm has not submitted applications for approval in the first place.

Thinking about the future, there is no reason for the Chinese vaccine industry to be limited to supplying its own country and others in the developing world. The world of vaccine diplomacy is competitive and complicated, and geopolitical and geoeconomic factors also have to be considered.

However, enriching and strengthening networks of researchers, scientists and engineers in different countries can hopefully help ameliorate such consequences on further development of the Chinese vaccine industry.

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The current political and diplomatic atmosphere may not favour bilateral contacts between Chinese vaccine professionals and their peers in the United States and a few other countries with stringent regulatory authorities for vaccines and other medical products. That, however, is precisely the reason for preserving an international network of exchange through multilateral channels.

One option China should consider is procuring vaccines made by American and European companies through the Covax advanced marketing mechanism. Alongside, China can also encourage science-based interactions between vaccine professionals in China and abroad.

Inclusion of a Chinese-made Covid-19 vaccine in the WHO’s emergency use listing is a marker of achievement for the country’s vaccine industry, though its journey to excellence still has a long way to go.

China should be proactive in working with the WHO and other international bodies to ensure Covax and similar schemes are a success. Being active in multilateral channels is also conducive to China’s eventual entry into markets with stringent regulatory authorities for vaccines and medical products.

Zha Daojiong is a professor in the School of International Studies and Institute of South-South Cooperation and Development at Peking University