China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced 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.
Design and Clinical Trial Progress of SYS6006
SYS6006 is designed with targeted antigenic mutations based on the prevalence of the virus strain. 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 and Efficacy Profile of SYS6006
The incidence and severity of adverse events associated with SYS6006 were found to be 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, which is 83 times higher than before the booster dose.
Cross Neutralization and T Cell Immunity
Sequential immunization with one dose of SYS6006 on the basis of two or three doses of inactivated vaccine demonstrated 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, irrespective of whether it is used for primary immunization or as a sequential booster. The vaccine maintains a high level of cellular immunity and shows approximately the same intensity for different virus strains.-Fineline Info & Tech
