China plans to approve first foreign COVID-19 vaccine by July

Chinese officials have been scrutinising clinical-trial data for the coronavirus vaccine made by Germany’s BioNTech-Pfizer.

People receiving the China National Biotec Group vaccine in China's southwestern Chongqing last week. Picture: AFP

China is planning to approve its first foreign COVID-19 vaccine before July, according to people familiar with the matter, as pressure mounts from domestic scientists and the foreign business community to expand beyond the country’s own roster of shots.

Chinese officials have been scrutinising clinical-trial data for the coronavirus vaccine made by Germany’s BioNTech-Pfizer and are expected to green light domestic distribution of the shot within the next 10 weeks, people privy to these discussions say.

Most of China’s shot makers cite trial data showing that their vaccines are close to 100 per cent effective in preventing COVID-19 infections serious enough to require hospitalisation when fully administered. But some Chinese public-health experts, including the head of China’s Centre for Disease Control and Prevention, have pushed for the introduction of Western vaccines that are better at preventing milder infections.

Foreign businesses are eager to add Western vaccines to make it easier to travel overseas, where foreign shots are more accepted, according to Ker Gibbs, the president of the American Chamber of Commerce in Shanghai. The chamber has been urging the government to approve the BioNTech vaccine, which is being produced and distributed by Pfizer in most of the world, since December, he said.

BioNTech agreed in December to work with Shanghai Fosun Pharmaceutical Group to deliver 100 million doses to China in 2021, pending approval.

The timetable for approval isn’t fixed, and the decision depends in part on approvals for Chinese vaccines abroad, according to some of the people familiar with the deliberations, suggesting the timing of the approval is being driven to a certain degree by politics.

The World Health Organisation is reviewing vaccines by Chinese state-owned drugmaker Sinopharm and private Chinese company Sinovac Biotech. for possible emergency-use approval by early May, according to its most recent vaccine status report. The US hasn’t approved any Chinese COVID-19 vaccines.

Health authorities in Chile on Friday released the results of a study of 10.5 million people, which showed that the Sinovac vaccine was 16 per cent effective against infection after one dose and 67F per cent effective after the second dose. BioNTech and Pfizer recently reported high efficacy, at 91.3 per cent, up to six months after a second dose of their COVID-19 vaccine, based on results in people enrolled in Phase 3 trials.

BioNTech said it is working on making the vaccines available in China upon approval. Fosun declined to comment.

The Ministry of Science and Technology, the National Health Commission and the National Medical Products Administration didn’t respond to requests for comment.

China has approved four domestic vaccines for general use and one for emergency use. Despite having the virus under control, the country has been ramping up a vaccination drive that aims to get 40 per cent of its population, or about 560 million people, immunised by summer. While trying to vaccinate its own population, China has also exported more than 115 million doses this year, most to the developing world, according to data collected by science-analytics company Airfinity.

Part of the decision on BioNTech is motivated by the 2022 Winter Olympics, which are scheduled to take place in China in February. Beijing expects the majority of the athletes coming to the games to take the BioNTech shot, according to one of the people briefed on the discussions.

George Gao, the head of China’s CDC, has argued that China should embrace vaccines, such as BioNTech’s, that are based on advanced mRNA technology and have registered efficacy rates in the 90 per cent range for even mild cases.

One way to improve the “not high” efficacy of conventional vaccines, Mr Gao said at a conference on Saturday, is for authorities to combine them with shots based on a different technology such as mRNA. Shots by Chinese drugmakers range in efficacy from 50 per cent to 80 per cent for mild to moderate infections.

BioNTech signed an initial collaboration agreement with Fosun to develop and distribute its vaccine in China, Hong Kong and Macau more than a year ago. The vaccine is in use in Hong Kong and Macau.

The delay in approval for the vaccine in mainland China points to the complexity of the regulatory decisions in the age of vaccine nationalism, public-health experts say.

It would be in China’s interest to adopt and use different vaccine platforms, “but all regulatory decisions are partly based on science and partly on economic and political considerations,” said Vivian Lin, a public-health professor at the University of Hong Kong and former official at the WHO.

Delays in vaccine approval have been a source of anxiety for some businesses. According to a recent survey of the American Chamber of Commerce in Shanghai, almost 40,000 people from its member companies have indicated that they would like to take the BioNTech vaccine.

“Vaccines are soon likely to become a requirement for international travel,” said Andreas Feege, a board member of the northern China branch of the German Chamber of Commerce in China. “Providing mutual recognition of vaccines will not only benefit the foreign business community, but also Chinese citizens who must travel overseas.”

Beijing’s approval of BioNTech’s vaccine could speed up reciprocal vaccine recognition needed for vaccine passports to work, said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations in New York.

The process in China could be bolstered by the WHO deciding to put Sinovac and Sinopharm vaccines on their emergency-use list, said Mr Huang, adding that the international recognition would give China the confidence to allow for foreign competitors.

Sinopharm and Sinovac presented data on their COVID-19 vaccines suggesting that efficacy rates met the 50 per cent threshold required by the WHO, Alejandro Cravioto, the chair of a WHO advisory panel, said in late March.

The Wall Street Journal