China has approved the emergency use of a self-developed recombinant protein subunit vaccine against COVID-19, its main developer, the Institute of Microbiology under the Chinese Academy of Sciences, said on Wednesday.
Uzbekistan approved the use of the Chinese vaccine on March 1, and China issued emergency use authorization on March 10.
The level of neutralizing antibody elicited by the vaccine is comparable to other COVID-19 recombinant protein vaccines and mRNA vaccines in the world, according to an institute statement.
The vaccine (CHO Cells) completed phase-1 and phase-2 clinical trials in October 2022. Results support the safety and immunogenicity of this vaccine, with no severe adverse reactions reported.
Jointly developed by the institute and Anhui Zhifei Longcom Biopharmaceutical Co. Ltd., the patented vaccine is the worlds first COVID-19 recombinant protein subunit vaccine approved for clinical research permit and the fourth COVID-19 vaccine approved for emergency use in China.
Recombinant protein subunit vaccine does not need a high-grade biosafety laboratory for manucture, and can quickly achieve large-scale production. It is more cost-efficient and easier to store and transport, the vaccine maker said.
Researchers have been holding phase-3 trials since November 2022 in China, Uzbekistan, Pakistan, Ecuador and Indonesia, planning to enroll up to 29,000 adults.China approves one more COVIDQQ19 vaccine for emergency use