'Domestic COVID-19 Vaccine' Development Accelerates... Clinical Trial Standard Guidelines Released

A researcher is conducting research related to the development of a COVID-19 vaccine at the Cellid Cell Gene Therapy GMP Center in Seongnam-si, Gyeonggi Province.
[Photo by Yonhap News]

[Asia Economy Reporter Lee Chun-hee] The 'Our Vaccine Project' for the development of a domestically produced COVID-19 vaccine is set to officially commence.

The Ministry of Food and Drug Safety (MFDS) announced on the 31st the establishment and release of the 'Standard Clinical Trial Protocol for COVID-19 Vaccines' as part of the Our Vaccine Project.

The Our Vaccine Project is an initiative by the MFDS to support the entire development process?from research and development (R&D) to approval?aimed at achieving self-sufficiency with domestically produced vaccines in preparation for emerging infectious disease threats such as COVID-19. Currently, five domestic companies?SK Bioscience, Genexine, GeneOne Life Science, Cellid, and UbioLogics?have received approval for their vaccine clinical trial plans and are conducting trials. The MFDS has determined that this is a critical time requiring more specialized support to enter phase 3 clinical trials and commercialize domestic vaccines, and plans to provide such support through the Our Vaccine Project.

The establishment of this standard clinical trial protocol is the first step toward that goal. The standard includes three types: ▲Phase 1 and 2 clinical trials ▲Phase 3 clinical trials (general efficacy trials) ▲Phase 3 clinical trials (comparative trials), designed to guide domestic pharmaceutical companies with limited vaccine development experience in easily preparing clinical trial protocols.

The conventional vaccine development method has proceeded through phase 3 general efficacy clinical trials requiring tens of thousands of participants. This requires recruiting a placebo control group that does not receive the vaccine. However, as COVID-19 vaccinations have become widespread domestically, recruiting a control group has emerged as the biggest obstacle to developing domestic vaccines.

In response, the MFDS proposed the design of a 'phase 3 immunogenicity comparative clinical trial' as an alternative, which can be conducted without large numbers of participants or placebo control groups. Comparative trials measure vaccine efficacy by comparing immune response indicators between thousands of participants vaccinated with an already approved vaccine and those vaccinated with a domestically developed vaccine.

Among the standard clinical trial protocols, the phase 3 comparative trial standard particularly reflects this situation by providing detailed criteria such as selection of comparator vaccines, clinical design (non-inferiority or superiority), evaluation variables, success criteria (margins), rationale for the number of participants, and statistical analysis methods.

The MFDS stated, "We expect this standard protocol to minimize trial and error in the vaccine development process for domestic researchers, enabling faster clinical trials," and added, "We will continue to provide close support to ensure the success of the ‘Our Vaccine Project’ by preparing guidelines for comparative trials and variant-targeted vaccine development, offering tailored quality control throughout the entire development cycle, and providing one-on-one customized technical support for each development item, so that domestically produced COVID-19 vaccines can be developed swiftly."

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