Another Significant Progress in Delta-specific COVID Vaccine Development—Rong’an Bio Begun Rolling Submission to CDE

2021-11-29 Source:Zhitong Caijing

With the continuous outbreaks of COVID variant, countries around the world have been deliberating whether to close the customs again, and European and American countries which expected co-existence with virus have begun to reexamine the feasibility of relevant policies. In China, as its zero-COVID policy has contributed greatly to the society in epidemic prevention and control while substantially reducing the burden on its public healthcare system, the Delta-specific COVID vaccine independently developed by China is reported to be one step close to commercialization. According to public information, the inactivated Delta-specific COVID vaccine under R&D by Rong’an Bio, a wholly-owned subsidiary of AIM Vaccine (which is forging ahead with its plan for listing on the HKEX), has now entered the stage of non-clinical animal evaluation, including animal safety evaluation, immunogenicity evaluation and protective evaluation, and Rong’an Bio has begun rolling submission of application documents to the Center for Drug Evaluation (CDE), NMPA.


It is learned that a technical cooperation agreement has been reached between Rong’an Bio and Zhejiang Provincial Center for Disease Control and Prevention this May, to develop the second generation of inactivated COVID vaccine targeting Delta variant. Rong’an Bio is among the first batch of companies to develop vaccine with isolated Delta variant. The Research and Development of Delta-specific COVID Vaccine they have been cooperating on has been rated as one of the 2022 “trailblazer” programs of Zhejiang Province for tackling key problems.


Feng Zijian, a researcher of the Chinese Center for Disease Control and Prevention, once said: according to the WHO’s studies, the transmission rate of Delta variant has grown by nearly 100% compared to other variants; meanwhile, its incubation period and passage interval have been shortened by 1-2 days on average. He warned that, without strong and effective prevention and control measures to intervene and immunization through vaccination to stop the spreading, the transmission speed of COVID-19 will increase exponentially and the difficulty of prevention and control will be enhanced correspondingly.


Targeting the Delta variant of high viral load, short incubation period and high transmission speed, AIM Vaccine with its wholly-owned subsidiary Rong’an Bio is striving to accelerate the R&D of relevant vaccines, and at the same time making full preparation for vaccine production by virtue of its strength and advantages in industrialization.


According to previous official information, in Ningbo Free Trade Zone, the construction of its inactivated COVID-19 vaccine production workshop of high biosafety grade—which is commonly known as P3 workshop in the industry—has already been completed, with a designed annual production capacity of 500 million doses. Meanwhile, its laboratory of high biosafety grade located at the same site is under efficient construction.


The prospectus of AIM Vaccine revealed that it has begun rolling submission of application for inactivated Delta-specific COVID vaccine to the CDE, and plans to initiate clinical trials next year. Also, AIM Vaccine is speeding up the R&D of mRNA COVID-19 vaccines targeting variants.