China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the initiation of a Phase IIIb clinical study with ethics approval. The study is designed to assess the immunogenicity and safety of its “novel coronavirus variant mRNA vaccine” (S protein chimera) in individuals aged 18 and above who have completed three doses of COVID-19 inactivated vaccines as a booster shot.
Vaccine Profile
The “novel coronavirus variant mRNA vaccine” (S protein chimera) is an innovative broad-spectrum mRNA vaccine designed and developed for the 2019-nCoV variants. It encodes a full-length S protein chimera. Walvax Bio partnered with Fudan University and RNACure Bio in February this year to develop a broad-spectrum mRNA vaccine based on the S protein, creating an innovative and efficient mRNA vaccine technology platform. The vaccine antigen design covers major immune escape mutation sites of multiple variants.
Preclinical Findings
Preclinical studies have shown that the vaccine has good safety and protective effects. It also demonstrates a certain cross-neutralization ability against major variants of concern (VOCs), including Omicron. These findings highlight the potential of the vaccine to provide broad-spectrum protection against COVID-19 variants.
Future Development
The initiation of the Phase IIIb study marks a significant step forward in the clinical development of Walvax’s mRNA vaccine. The company aims to further validate the vaccine’s immunogenicity and safety in a larger population, potentially offering a new and effective booster option for individuals who have already received inactivated COVID-19 vaccines.-Fineline Info & Tech
