China grants conditional approval to Sinovac's vaccine ahead of WHO's field inspection next week
China grants conditional approval to Sinovac’s vaccine ahead of WHO’s field inspection next week
Published: Feb 06, 2021 08:18 PM

The vaccine developed by China's Sinovac. Photo: VCG

China's drug regulator has given conditional approval for the mass use of COVID-19 vaccine produced by Chinese pharmaceutical firm Sinovac Biotech, China's second COVID-19 vaccine. 

Experts believe that it will be conducive for emergency use or registration of the Chinese vaccine in the international market, and will help Chinese vaccines play a better role as a global public good, as the two vaccines are both at the very advanced stage for World Health Organization's assessment in emergency use listing. 

Sinovac Biotech announced on Saturday that CoronaVac, an inactivated vaccine candidate against COVID-19, received authorization from China's National Medical Products Administration for conditional mass use in China on Friday. 

The conditional market approval was based on the results of the overseas Phase-III clinical trials of CoronaVac. So far, Sinovac has released the preliminary results of Phase III clinical trials in Brazil and Turkey. Final data from the trials has not been made available yet and the results of its efficacy and safety require further confirmation, Sinovac said in a statement sent to the Global Times on Saturday. 

Sinovac has completed its second production line for vaccine concentrates, and the two lines will ensure that the annual production capacity of Sinovac's concentrates exceeds a billion doses. 

CoronaVac was first approved for emergency use in China in June 2020, and it has received emergency approval in other countries, including Indonesia, Turkey, Brazil, Chile and Colombia since January. CoronaVac is China's second homegrown COVID-19 vaccine to be granted conditional approval for the country's domestic market. The inactivated vaccine developed by the Beijing Biological Products Institute under Sinopharm's subsidiary China National Biotec Group was China's first COVID-19 vaccine to receive conditional approval on December 31, 2020. 

Shao Yiming,China's leading physician-scientist and immunologist serving at the Chinese Center for Disease Control and Prevention, told the Global Times on Saturday that the conditional approval represented a confirmation by China's drug authorities of the vaccine's safety and efficacy. 

With the conditional market approval, it will be more convenient for the emergency use or registration of the vaccine in the international market and will help Chinese vaccine play a better role as a global public good, and is of significance to epidemic prevention and control worldwide, Shao said. 

Sinovac and Sinopharm's COVID-19 vaccines are at the very advanced stage of the WHO's reviews for emergency use listing, and WHO inspectors who arrived in China in mid-January will start inspections next week, the WHO said on Friday. 

A source close to Sinovac told the Global Times on condition of anonymity on Saturday that the WHO inspectors had a virtual meeting with Sinovac during their quarantine in China, and has read many materials.

The source said that WHO inspectors will make field inspections at the Beijing company for four days next week, visiting production lines, facilities, management and personnel. 

China announced it would provide 10 million doses of COVID-19 vaccine to COVAX, and Chinese vaccine enterprises are producing as many vaccines as possible to meet the needs of China and other countries. 

In the latest move, China decided to provide the first batch of vaccine aid to Nepal, Chinese State Councilor and Foreign Minister Wang Yi said during a phone conversation with Nepali Foreign Minister Pradeep Kumar Gyawali on Friday. 

After offering the first batch of vaccines to Pakistan, Chinese military planned to donate a COVID-19 vaccine to Pakistan military, Chinese ambassador to Pakistan Nong Rong said.