Vaccine gets conditional approval for general use

China has granted conditional market approval for its first COVID-19 vaccine, paving the way for mass immunization for thorough epidemic control and prevention, authorities said on Dec 31.

The inactivated vaccine, developed by State-owned Sinopharm, which was approved on Wednesday night, is safe and has a 79.34 percent efficacy, based on data from the ongoing phase 3 clinical trial, Chen Shifei, deputy commissioner of the National Medical Products Administration, the top drug regulator, said at a news conference at the State Council Information Office.

Although the administration conducted strict inspection and evaluations using international standards before granting the approval, it will continue to carry out strict supervision over the product and its producer after market approval to ensure the phase 3 trial is completed according to standards, he said.

Prior to the conditional approval by the administration, the vaccine had already gained approval for general use in the United Arab Emirates on Dec 9 and in Bahrain on Dec 13. The large-scale phase 3 trial of the vaccine has involved more than 60,000 participants of 125 nationalities, according to the company.

China has been leading in the research and development of COVID-19 vaccines since the start of the pandemic. A total of 14 COVID-19 vaccines developed by China are now in clinical trials, including five in phase 3 trials, the large, final trial before a vaccine is approved for market, Chen said. All the phase 3 trials have to be conducted overseas as the epidemic is under effective control in China.

Before the official approval of the Sinopharm vaccine on Thursday, the vaccine and several other COVID-19 vaccines in phase 3 trials had already been put into emergency use in China, starting in June. More than 4.5 million doses have been given on a voluntary basis to high-risk or priority groups such as front-line medical workers and people going overseas to work, and the safety and efficacy of the vaccines have been proved, said Zeng Yixin, vice-minister of the National Health Commission.

"Following the conditional approval today, and in particular, with the gradual increase in the production capacity of vaccines, we will promote vaccination among groups more vulnerable to COVID-19 such as the elderly and those with other medical conditions, and then a universal vaccination will follow," he said, adding the vaccines will be provided to all people in China at no cost.

"An immunity barrier will be established among the whole population to cut off transmission of the novel coronavirus, so the epidemic can be thoroughly contained in China."

Eighteen domestic vaccine producers have started to prepare for mass production, according to Mao Junfeng, vice-director of the Department of Industry of Consumer Products of the Ministry of Industry and Information Technology. The production capacity for COVID-19 vaccines in China will be able to meet the requirements for massive domestic vaccination, he said.

Shen Bo, an official at the international department of the Ministry of Foreign Affairs, said after production of COVID-19 vaccines starts, China will honor its commitment and supply the vaccines to the world as a public good.

"We have been paying a great deal of attention to the accessibility and affordability of the vaccines for developing countries, and will consider supplying vaccines to developing countries in various forms, including donations," he said. "We also call on the international community to work together to promote a fair distribution of COVID-19 vaccines globally, so they become a public good accessible and affordable to people in all countries."

Xu Nanping, vice-minister of science and technology, said there is currently no evidence showing that existing genetic mutations in the novel coronavirus have any substantial effect on how well the COVID-19 vaccines work.

Despite that, China has been closely monitoring the mutations and has devoted experts and resources to specifically handling the issue to ensure the supply of safe and effective vaccines to the people, he said.