China-based Clover Biopharmaceuticals Ltd (HKG: 2197) reported positive Phase III trial results for its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The study demonstrated superior neutralizing antibody responses against the wild strain and Omicron subvariants BA.1/BA.2 compared to homologous inactivated vaccine boosters.
Trial Design and Results
The double-blind, randomized trial evaluated SCB-2019 as a heterologous booster in participants who previously received two doses of inactivated vaccines. Preliminary data showed higher antibody levels post-SCB-2019 administration versus a third dose of inactivated vaccine. The study enrolled over 1,500 adults and elderly subjects in the Philippines, with a sub-cohort assessing SCB-2019 as a fourth booster in triple-vaccinated individuals.
Global Regulatory and Commercial Plans
Clover aims to file for approvals with China’s NMPA, the European Medicines Agency (EMA), and the World Health Organization (WHO) later this year. The company is also preparing for commercial rollout in China and international markets, leveraging SCB-2019’s differentiated profile as a heterologous booster.-Fineline Info & Tech
