Reporters learned from an online press conference held by Sinopharm’s China National Biotec Group (CNBG) on the 27th that the inactivated COVID-19 vaccine targeting the Omicron variant, developed by CNBG, received clinical trial approval from the National Medical Products Administration (NMPA) on the 26th. This means the vaccine will enter the clinical trial stage.

Yang Xiaoming, Chief Engineer of Sinopharm and Chairman of CNBG, introduced that following the guiding principles and R&D strategies for modified COVID-19 vaccines set by the NMPA, CNBG initiated the development of the Omicron variant inactivated vaccine on December 9, 2021. Utilizing its newly established P3 high-level biosafety laboratory, CNBG completed the screening, passaging, and amplification of the Omicron strain, established a three-tier master seed bank, and finished process validation, preparation of multiple batches of scaled products, quality standard research, as well as in vivo safety evaluation and immunogenicity studies in animals. The results showed that the inactivated COVID-19 vaccine targeting the Omicron variant can induce high titers of neutralizing antibodies against the Omicron variant and multiple other variants.

"Whether the vaccine can generate effective neutralizing antibodies against the Omicron variant is a key challenge in its development. Preclinical studies indicate that the vaccine exhibits good neutralizing activity against the Omicron variant, and animal studies show it provides some protective effect against Omicron variant infection," said Zhang Yuntao, Chief Scientist and Vice President of CNBG. He added that the vaccine's protective efficacy still needs to be further observed in clinical studies.

It is reported that CNBG will conduct sequential immunization clinical studies using a randomized, double-blind, cohort study design in individuals aged 18 and above who have already received 2 or 3 doses of COVID-19 vaccines, to evaluate the safety and immunogenicity of the Omicron variant inactivated vaccine. Clinical vaccination regimens for those who have not yet received any COVID-19 vaccine will also be studied.