Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV.
“The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.
Chen said that the NMPA looked at data from early pharmacokinetic studies, domestic phase I and II studies, as well as phase III studies from overseas and inspected the phase I/II trial sites in China. Strict supervision will continue to be carried out over the vaccine to ensure its safety and quality, he added.
Regulators from the United Arab Emirates (UAE) and Bahrain approved the vaccine on Dec. 9 and Dec. 13, respectively.
The NMPA approval was announced a day after CNBG released data from phase III trials noting that the inactivated virus vaccine provides 79.34% protection against the coronavirus and a week after the regulator accepted an NDA for it on Dec. 24. The efficacy rate meets requirements set by both the NMPA and the World Health Organization (WHO).
BBIBP-CorV was developed by the Beijing Institute of Biological Products Co. Ltd, a subsidiary of CNBG, which is itself a subsidiary of China National Pharmaceutical Group Corp. (Sinopharm). The vaccine is one of two that CNBG is developing.
CNBG has yet to provide detailed efficacy data for the vaccine but it has phase III trials underway in the UAE, Peru, Bahrain, Egypt, Jordan and Argentina, involving over 60,000 volunteers with 125 nationalities. The company had earlier carried out a randomized, double-blind, placebo-controlled, phase I/II trial in China’s Henan province that involved 640 participants.
Although a large-scale phase III trial was not conducted in China, BBIBP-CorV obtained emergency use approval in June, under which people from high-risk groups could voluntarily choose to get vaccinated.
“By late November, 1.5 million doses were given and around 60,000 vaccine recipients went to high-risk places overseas to work. There were no severe infection cases, fully proving the vaccine’s safety and somewhat its efficacy,” said Zeng Yixin, vice minister of China's National Health Commission during the Dec. 31 press conference. He added that another three million doses have been given out since Dec 15.
Zeng said that there were adverse reactions such as localized pain and hardness. Light fever accounted for less than 0.1% of the adverse reaction reports, while reports of more serious reactions accounted for 0.0002%.
Still waiting for the data details
Little is known about the phase III data of BBIBP-CorV other than a brief statement from CNBG on Dec. 30. The company’s vice president Wu Yonglin said in the press conference that more data will be unveiled and published in journals at a later time.
The company started R&D into COVID-19 vaccines on Jan. 19 with funding of ¥1 billion (US$153 million) and BBIBP-CorV received IND approval on April 27. Between June and August, CNBG launched phase III trials overseas.
With this first conditional approval in place for a COVID-19 shot, China will move forward with plans for mass vaccinations, starting with the elderly and high-risk groups, then the general public.
Chinese companies currently have 14 COVID-19 vaccine candidates in the clinic with five in phase III trials, said China's Vice Science and Technology Minister Xu Nanping during the press conference.
CNBG’s other COVID-19 vaccine candidate is being developed by its subsidiary Wuhan Institute of Biological Products.
Another Chinese vaccine developer, Sinovac Biotech Ltd., has a COVID-19 candidate undergoing phase III trials in multiple countries and is expected to release data in mid-January 2021. Coronavac, an inactivated virus vaccine, is on track to win approval in Brazil.
Cansino Biologic Inc. has Ad5-nCoV, a single-dose human adenovirus vaccine, it developed with the Academy of Military Sciences, in phase III trials.
Anhui Zhifei Longcomp Biologic Pharmacy Co. Ltd. started recruiting on Dec. 16 for a randomized, double-blind, placebo-controlled multicenter phase III trial involving 29,000 people of a recombinant protein subunit vaccine, ZF2001, it developed with the Institute of Microbiology of the Chinese Academy of Sciences. Anhui Zhifei is a division of Chongqing Zhifei Biological Products Co. Ltd.