China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has revealed that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country.
SYS6006 Design and Clinical Trial Progress
SYS6006 is designed with targeted antigenic mutations based on the prevalence of the strain, ensuring relevance against circulating variants. The vaccine was approved to enter clinical trials in China in April 2022 and has since completed Phase I, II, and sequential booster studies. These trials have confirmed the safety, immunogenicity, and protective efficacy of SYS6006.
Safety Profile and Efficacy of SYS6006
The incidence and severity of adverse events in SYS6006 were relatively low, with the primary adverse events being fever and pain at the injection site, classified as Level 1 and Level 2. Notably, the elderly group experienced a significantly reduced incidence and severity of adverse events compared to the adult group, presenting a better risk-benefit ratio. After a booster dose of SYS6006, the geometric mean titer (GMT) of the Omicron BA.5 neutralizing antibody was 236 on day 14, 83 times higher than before the booster dose.
Cross Neutralization Effect and T Cell Immunity Induction
Sequential immunization with one dose of SYS6006 on the basis of two or three doses of inactivated vaccine showed a good cross-neutralization effect on various strains, including Omicron BA.5, BF.7, BQ.1.1, XBB.1.5, and CH.1.1. Clinical research results indicate that SYS6006 can continuously induce specific T cell immunity against wild strains, Delta, Omicron BA.2, and BA.5 strains, regardless of whether it is used for primary immunization or as a sequential booster. The vaccine maintains a high level of cellular immunity durably and exhibits approximately the same cellular immunity intensity for different virus strains.-Fineline Info & Tech
