In this Dec 25, 2020 file photo, released by Xinhua News Agency, a staff member inspects syringes of COVID-19 inactivated vaccine products at a packaging plant of the Beijing Biological Products Institute Co Ltd, in Beijing. (ZHANG YUWEI/XINHUA VIA AP)
BEIJING - China announced on Thursday that it had granted conditional marketing authorization for its first self-developed COVID-19 vaccine.
The inactivated vaccine, which got the approval from the National Medical Products Administration (NMPA), is developed by the Beijing Biological Products Institute Co, Ltd. under the China National Biotec Group (CNBG), which is affiliated with Sinopharm.
The interim results of its phase-3 clinical trials show 79.34 percent efficacy against COVID-19, meeting the standards of the World Health Organization and the NMPA, according to a press conference by the State Council joint prevention and control mechanism against COVID-19.
This vaccine will be provided free of charge to all Chinese people.
Zeng Yixin, deputy head, National Health Commission
China has adopted five technological approaches in developing COVID-19 vaccines. Since July, a number of Chinese vaccine candidates have carried out phase-3 clinical trials overseas, said Zeng, adding that China has been at the global forefront of COVID-19 vaccine development.
China approved the emergency use of COVID-19 vaccines in June, targeting groups with high risks of infection. By the end of November, more than 1.5 million doses of Chinese COVID-19 vaccines had been distributed for emergency use, and 60,000 vaccinated people have traveled abroad to high-risk regions, with no severe adverse reactions reported, Zeng said.
On Dec 15, China officially launched a vaccination program for this winter-spring period targeting a number of key groups, including those engaged in handling imported cold-chain products, customs officers, medical workers and people working in public transport and fresh markets. In the past 15 days, the number of doses of vaccination among the key groups exceeded 3 million.
"The 3 million vaccine doses, plus the previous 1.5 million doses, fully prove that Chinese vaccines are safe," Zeng noted.
After the COVID-19 vaccines are approved to enter the market, especially when production capacity increases, China will comprehensively vaccinate senior citizens, people with underlying conditions, and the general public in an orderly manner, the NHC official said.
Chen Shifei, deputy head of the NMPA, said at the conference that the conditional approval was granted according to relevant laws.
The NMPA will urge the company to continue carrying out the phase-3 clinical trials as planned and ensure the research quality after the conditional approval. The company needs to report abnormal reactions to the vaccination and update the vaccine instructions on time, Chen said.
The NMPA will also strengthen the whole-chain supervision of the vaccine. It has established a traceability information system for the management of approved vaccines, Chen added.
Wu Yonglin, president of the CNBG, said the company has carried out large-scale phase-3 clinical trials in the United Arab Emirates, Bahrain, and other countries, involving 60,000 volunteers of 125 nationalities.
The United Arab Emirates and Bahrain approved the vaccine's registration according to the World Health Organization technical standards in December. More detailed data on the vaccine will be released later. It will also be published in scientific journals, Wu said.
HONG KONG NEWS