China is trying to reshape its pharmaceutical industry and take on an unprecedented role as a major vaccine supplier to the rest of the world in light of the ongoing Covid-19 pandemic. It aims to produce enough doses to vaccinate 70 per cent of the country’s population, or 980 million people, and the same amount for export by the end of the year, according to Feng Duojia, president of China Association for Vaccines. By March, more than 100 million doses had been exported, about the same as the combined exports from India and the European Union. Feng said the target is to produce 5 billion doses of Covid-19 by the end of next year. The figure is about 10 times its total vaccine output before the start of the pandemic - in 2019 the Chinese drug regulator signed off 528 million doses of domestic vaccines. “China is building 18 production lines and each large-scale production line is like building a new China National Biotec Group,” Feng said, referring to the dominant player in the national vaccine making industry. Biotec, a subsidiary of the state-owned China National Pharmaceutical Group (Sinopharm), and Sinovac have produced 250 million doses of Covid-19 vaccines which have been administered in China and overseas. The growth in production means China will have a better chance of increasing its influence among developing countries which will look to it, along with India and Russia, to help offset the unequal global distribution of vaccines. But observers warned it needs to raise the quality of its vaccines to international standards and gain authorisation from the likes of the World Health Organization before becoming an internationally recognised supplier. “To produce such large quantities while ensuring the product quality meets international or even higher standards will be a huge challenge,” Feng said. “The time window is very short – we need to raise our product quality quickly within one or two years … Covid-19 is pushing us to be excellent. Our vaccines must steadily maintain world-class standards and strive to be one of the world’s best.” Feng said the industry has made it its mission to provide large quantities of accessible and affordable vaccines after President Xi Jinping promised to provide them as a “global public good” during the World Health Assembly’s meeting last year. Chile says Sinovac vaccine 67 per cent effective against symptomatic cases “To meet other countries’ quality requirements and have our brands and services recognised, domestic vaccines must first pass the WHO’s prequalification process or be recognised by regulatory bodies,” Feng said. Yuan Yuan, a Chinese representative at the Programme for Appropriate Technology in Health, a global health non-governmental organisation, said low and middle-income countries, especially in Sub-Saharan Africa, rely on WHO prequalification and this will be a must for Chinese vaccines. The organisation previously helped the Chengdu subsidary of Sinopharm through the prequalification process for a vaccine against Japanese encephalitis in 2013. During a public health crisis like Covid-19, a simplified procedure called emergency use listing would be used for United Nation agencies, including when Uncief buys vaccines for the Covax Facility initiative to ensure equal access. Currently 19 vaccines are going through the process, including five made by Chinese firms. The results for two of these, made by Sinopharm’s Beijing subsidiary and Sinovac, are expected by the end of the month or early in May. Yuan said securing emergency use status would be the “most effective way” Chinese firms can help African countries, but the process can be challenging especially for those who have no previous products that passed prequalification. Four non-Covid-19 Chinese vaccines have passed the WHO’s prequalification process, but they spent several years in preparation. “Emergency use listing requires the production facility to meet Good Manufacturing Practice standards and the WHO still sends a team to conduct on-site inspections at companies that have pre-qualified products. “For companies that have no experience in prequalification, it will be a challenge for them to pass the site inspection and document verification process,” Yuan said. China has promised nearly half a billion vaccines through bilateral deals signed before the vaccines had secured an emergency use listing. Analysts said extensive supplies of Chinese vaccines will make a difference to middle and low-income countries, which would rather have the Chinese vaccines than nothing, even if they have a lower efficacy rate than some Western-made vaccines. Revolutionary mRNA vaccines made by Chinese firms will be ready to hit market by end of year, says industry chief “Many poor countries see little likelihood of accessing the vaccines already being distributed in wealthier nations like the United States and in the European Union. China’s outreach has made their vaccines popular even if their efficacy is lower,” said Daniel Aldrich, a professor of political science, public policy and urban affairs with Northeastern University. He believes the unequal distribution of vaccines will persist even after affluent countries have inoculated enough of their population to establish an immunity barrier. “China’s vaccines will still be sought after even as additional vaccines become available. There is a strong imbalance between wealthy and poorer countries and developing nations will continue to look to China for assistance, especially in areas like Southeast Asia,” Aldrich said. Jennifer Bouey, an epidemiologist and China health policy expert at Rand Corporation, agreed that the scaled up vaccine production comes in handy when the world needs to boost its manufacturing capacity to fight the epidemic. “The most critical barrier to stop the pandemic is the undercapacity [in vaccine production]. The world will need over 10 billion doses to vaccinate sufficient people to stop large scale virus transmission and continuing mutation. Until that threshold is met, no one is safe – even those who are vaccinated can still be reinfected when the virus has mutations that can escape the antibody created by the vaccine or previous exposures,” Bouey said. She also said that making a Chinese vaccine available to developing countries when demand is high and supplies are low will help increase the country’s influence and soft power. China is building a “health silk road” in parallel to the Belt and Road Initiative’s infrastructure projects, and is prioritising vaccine supply among participating countries. “In doing so China continues to seek to improve its influence and its soft power in areas which could be allies – or at least not competitors and opponents – on the world stage,” said Aldrich. He said the plan was opposed by the Quad countries – the United States, Australia, India and Japan – which are concerned about what they see as China’s increasingly aggressive stance. China’s first mRNA vaccine ready for final stage trials “In this sense China hopes to build allies … so that it can draw on their support should China need to appeal for assistance through international organisations,” Aldrich said. Last month, the leaders of the Quad countries pledged to boost vaccine production in India to “to benefit the entire Indo-Pacific” with the goal of distributing at least a billion doses of Covid-19 vaccines by the end of next year.