Rec-Bio Announces Completion of Enrollment and Vaccination in Phase II Head-to-Head Trial of ReCOV Against mRNA Vaccine

Zhitong Finance APP reported that Ruike Bio-B (02179) announced the comparison study between ReCOV and mRNA vaccines has been approved by the Philippines National Food and Drug Administration (FDA). The Phase II clinical trial comparing the group's recombinant protein COVID-19 vaccine ReCOV (ReCOV) with Pfizer’s mRNA vaccine COMIRNATY® has completed enrollment and dosing of all subjects. It took only two weeks from obtaining trial approval to completing enrollment and dosing of all subjects, fully demonstrating the high efficiency and execution capability of the group's clinical team.

This Phase II clinical trial has enrolled 600 participants. After the booster immunization is completed, all participants will undergo follow-up for safety and immunogenicity.

ReCOV is a recombinant COVID-19 vaccine developed by the company utilizing technology platforms such as novel adjuvants and protein engineering. It employs the self-developed novel adjuvant BFA03. According to relevant studies conducted by the company, ReCOV can induce high-titer broad-spectrum neutralizing antibodies and a Th1-biased T-cell immune response. It demonstrates good cross-neutralization and immune persistence against variant strains such as Omicron and Delta. It also has comprehensive advantages including overall good safety, easy scalability of production, low production costs, good formulation stability, and the ability to be stored and transported at room temperature.