(Yicai Global) Nov. 19 -- China's first recombinant Covid-19 vaccine (CHO cell) entered Phase III clinical trials yesterday.
These tests will also be carried out in Uzbekistan, Indonesia, Pakistan and Ecuador in future, Science and Technology Daily reported today.
The Phase III will be conducted on persons of at least 18 years of age. The research team plans to recruit 29,000 subjects for the trials.
Jointly developed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology under the Chinese Academy of Sciences, the inoculant is the sixth Covid-19 shot approved for clinical trials and the first to be clinically tested using recombinant subunit technology.
The vaccine is tolerated, safe and immunogenic, and the next clinical trial phase may thus continue, the results of Phase I and Phase II clinical trials that started on June 23 found.
Zhifei Longcom Biopharma has reportedly secured an addendum to its drug production license in September for an item related to recombinant subunit Covid-19 shot. Its vaccine workshop went into operation in the same month, with smooth trial production and an annual output of over 300 million doses.
Recombinant protein inoculants are made by expressing and purifying pathogen antigenic protein in engineered cells through genetic engineering. The jabs industrially produced through engineered cell lines feature high productivity, low cost and high accessibility.
China is currently developing vaccines from five technical routes -- inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines and nucleic acid vaccines. Five vaccines, including this one, are in separate Phase III clinical trials in Brazil, Pakistan, the UAE and Peru, a spokesperson from the Ministry of Foreign Affairs said at a press conference yesterday.
Shares of Anhui Zhifei Longcom Biopharma’s parent Chongqing Zhifei Biological Products [SHE:300122] closed up 0.93 percent at CNY120 (USD18.34) today.
Editor: Ben Armour, Xiao Yi