Kobibak Pediatric Phase 3 Clinical Trial Approved... "WHO Registration Expected in First Half of This Year"

[Asia Economy Reporter Park Hyungsoo] DA Technology announced on the 9th that the Russian Ministry of Health has approved Phase 3 clinical trials of the CoviVac vaccine for children.

The clinical trial will evaluate the tolerability, safety, and immunogenicity of CoviVac in children. The trials will be conducted at four medical institutions in the Perm, Samara, Saint Petersburg, and Moscow regions. A total of 1,050 pediatric patients will participate.

Based on research results showing that CoviVac used as a booster shot secures sufficient antibody levels to neutralize the Omicron variant, documents have been submitted to the World Health Organization (WHO) for clinical trials. Official registration is expected in the first half of this year.

DA Technology is promoting the establishment of a joint venture (JV) with Ajou University Advanced Medical Bio ICC and PBTG (Pharma Biotech Global) to build a domestic supply chain for the CoviVac vaccine, which is effective against variant viruses. They plan to supply an additional 300 million doses of reactors beyond the existing annual supply of 100 million doses. Ajou University ICC supports technology transfer, research and development, and human resources related to the CoviVac inactivated virion platform and participates in CoviVac production.

A company official stated, "Interest in the CoviVac vaccine continues as a pediatric vaccine and booster shot," adding, "In December last year, a key official from Alpha Group, a Russian investment specialist company, visited the Andong Animal Cell Validation Support Center and completed an on-site inspection of the CoviVac production facilities."

DA Technology expects domestic production to be possible by March.

This content was produced with the assistance of AI translation services.