China-based Sinocelltech Group Ltd (SHA: 688520) announced the inclusion of its recombinant novel coronavirus alpha+beta mutant S-trimer protein vaccine SCTV01C in the emergency use program in China. SCTV01C is a next-generation bivalent mutant recombinant protein vaccine being developed to prevent diseases caused by COVID-19. The active ingredient of SCTV01C contains two recombinant S trimer protein antigens of alpha and beta COVID, the main variants identified by the WHO, and uses a new oil-in-water adjuvant that can significantly enhance Th1 cells compared to the traditional aluminum adjuvant.
Clinical and Pre-Clinical Data
SCTV01C entered clinical trials in China in November last year, and is subject to multiple studies domestically and overseas. Pre-clinical and clinical data have shown that the drug is highly similar to COVID-19 inactivated vaccines in safety terms. When it comes to immunogenicity, the product can induce uniform and ultra-high titers of real virus-neutralizing antibodies against the current popular Omicron BA.1 and BA.5 variants, reaching pre-set superiority endpoints in relation to an inactivated vaccine and non-inferiority to Pfizer’s mRNA vaccine. Additionally, the neutralizing antibody titer remained at a high range 12 months after SCTV01C was administered as a booster shot, which showed the outstanding immune protection persistence of SCTV01C.-Fineline Info & Tech
