China conditionally approves Sinopharm vaccine

Chinese health regulators said on Thursday that they had given conditional approval to a coronavirus vaccine developed by state-owned Sinopharm. Chen Shifei, the deputy commissioner of the National Medical Products Administration, said at a news conference in Beijing that the decision had been made the previous night.

"For the vaccines that are urgently needed for responding to major public health emergency, the national drug administration can approve the registration application with conditions," said Chen. The inactivated, two-dose vaccine is the first one approved for general use in China. The go-ahead comes as the country carries out a campaign to vaccinate 50 million people before a major holiday for the Lunar New Year in February.

The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of state-owned conglomerate Sinopharm. The company announced Wednesday that preliminary data from last-stage trials had shown it to be 79.3% effective.

Final proof of its effectiveness will depend on publication of more data. Sinopharm is one of at least five Chinese developers that are in a global race to create vaccines for the disease that has killed more than 1.8 million people.

Conditional approval means that research is still ongoing, and the regulators can request more safety and effectiveness data about certain populations with different health profiles, Tao Lina, a former government immunologist, said at the news conference.

Usually, it means that the drug or product in question may be restricted for certain age groups, he said. Being asked about the price of the vaccine at the press conference, Zheng Zhongwei, a National Health Commission official said that it will be "in the limit of what people can afford," without giving a particular price.

The Beijing Institute vaccine is already under mass production, though officials did not answer questions about current production capacity. "Production capacity is a dynamic and continuous process," said Mao Junfeng, Vice Director of the Department of Industry of Consumer Products of the Ministry of Industry and Information Technology.