China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the safety, immunogenicity, and protective efficacy results of a Phase IIIb clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The vaccine was co-developed by Shanghai Llanque Biomedical Co., Ltd and Fudan University and obtained clinical trial approval in China in August 2022.
Study Design and Results
The randomized, double-blind, positive controlled study evaluated RQ3013 as a sequential booster in individuals who had completed three doses of COVID-19 inactivated vaccines at least six months prior. The main adverse reactions in the experimental group and the two control groups were mild to moderate and primarily occurred within seven days after vaccination. No serious adverse events related to the study vaccine were reported.
Immunogenicity and Protective Efficacy
On the 14th and 28th days after sequential booster immunization, the positive rate of neutralizing antibodies against BA.5 and the geometric mean titer (GMT) of neutralizing antibodies against RQ3013 were significantly higher than those of the control vaccine groups, meeting the statistical superiority criteria for immunogenicity evaluation. Additionally, the RQ3013 vaccine group demonstrated superior protection against symptomatic COVID-19 infection of any severity compared to the control groups.
Application and Safety
One dose of RQ3013 was administered to individuals aged 18 years and above who had previously received three doses of COVID-19 inactivated vaccine, showing good safety and effectiveness in boosting immunity.-Fineline Info & Tech
