This is China's first phase-3 efficacy study for a Recombinant subunit COVID-19 vaccine candidate, Anhui Zhifei Longcom Biopharmaceutical, said in a statement on Thursday.
A leading Chinese vaccine maker said it has commenced phase-3 clinical trials for its COVID-19 vaccine and is planning to recruit 29,000 volunteers across the world.
This is China’s first phase-3 efficacy study for a Recombinant subunit COVID-19 vaccine candidate, Anhui Zhifei Longcom Biopharmaceutical, said in a statement on Thursday.
Jointly developed by the company and the Institute of Microbiology under the Chinese Academy of Sciences, the vaccine was issued a clinical research permit from the National Medical Products Administration on June 19.
The company said the research, which plans to enroll up to 29,000 adults aged 18 and up, was launched on Wednesday in Xiangtan County, central China’s Hunan Province.
Global trials are expected to begin in Uzbekistan late this month, followed by trials in Indonesia, Pakistan and Ecuador.
A Chinese Foreign Ministry spokesman Zhao Lijian told a media briefing on Wednesday that five Chinese vaccine candidates are under clinical trials in countries, including the UAE, Brazil, Pakistan and Peru, and phase one and phase two clinical trials of some other vaccines are accelerated.
Researchers started phase-1 and phase-2 clinical trials on June 23, which were randomised, double-blind and placebo-controlled.
Volunteers, aged between 18 and 59 from Beijing, Chongqing and Hunan provinces, received the vaccine to determine whether it is safe for use on humans, state-run Xinhua news agency reported.
The results of the early-stage trials support the safety and immunogenicity of this vaccine, suggesting the potential for further clinical tests, it said.
The Chinese drug regulator granted the developers permission to conduct global multi-center research on November 4.
A COVID-19 vaccine manufacturing plant of the company was put into operation in September.
The annual production capacity for the COVID-19 vaccine will top 300 million doses, according to the company.
Coronavirus continues to ravage the world, with the total number of infected people standing at 57,011978 while deaths at 1,362,424, according to John Hopkins University.