Domestic Omicron Vaccine Developers "Need Support for Rapid Clinical Trials and Securing Comparator Vaccines"

On the 8th, when the additional COVID-19 vaccination (booster shot) began for Janssen vaccine recipients and inpatients, residents, and workers of nursing hospitals and nursing facilities, a Janssen vaccine recipient is receiving a booster shot at Yonsei With ENT Clinic in Seocho-gu, Seoul. Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Kim Daehyun] "Government support is needed for rapid clinical trial entry and the establishment of a mass vaccine production system to develop vaccines responding to the Omicron COVID-19 variant." "Domestic approval should be considered based solely on overseas clinical trial results of (domestically developed vaccines), and the government should secure clinical trial control vaccines."

Domestic COVID-19 vaccine developers appealed to the authorities at the 'Omicron Response Domestic Vaccine Development Status Meeting' hosted by Democratic Party lawmakers Lee Kwang-jae and Shin Hyun-young on the 22nd. The meeting was attended by the Ministry of Health and Welfare, the Ministry of Food and Drug Safety (MFDS), and representatives from domestic vaccine developers including SK Bioscience, Cellid, iGEN, UbioLogics, and GeneOne Life Science.

Lawmaker Shin said in her opening remarks, "As Omicron infections spread within the region, there are many difficulties such as securing hospital beds," adding, "It is important to increase vaccination rates, especially the third dose. How domestically developed vaccines will be used in preparation for the fourth dose is crucial."

The fastest-moving company currently is SK Bioscience. They plan to develop a vaccine effective against the entire coronavirus-related Sarbecovirus lineage using the platform of the COVID-19 vaccine 'GBP510,' which is currently in phase 3 clinical trials. Cho Tae-jun, head of development strategy at SK Bioscience, stated, "We are conducting phase 3 clinical trials domestically and internationally. In phases 1 and 2, we confirmed efficacy and safety, aiming for a launch in the first half of next year."

Regarding this, Lawmaker Shin said, "We will look for ways to exempt non-clinical trials or partially waive approval measures."

Cellid plans to apply for clinical trials by the end of February next year after efficacy evaluations. Kang Chang-ryul, CEO of Cellid, said, "Existing vaccines are expected to have difficulty maintaining long-term preventive effects," adding, "A 'dedicated vaccine' that induces a high level of antibody response to prevent the Omicron variant is necessary." He emphasized, "Government support is needed for rapid clinical trial entry and the establishment of a mass vaccine production system," and "Support for domestic vaccine development should be provided through guidelines for advance vaccine purchase promotion and confirmation of advance purchases."

UbioLogics also introduced the development status of the 'Ucovac19' vaccine and requested government support including securing vaccines and clinical trial control vaccines, stating, "Domestic approval should be considered based solely on overseas clinical trial results of (domestically developed vaccines)."

A Ministry of Health and Welfare official said, "To expedite vaccine development, the Korea Disease Control and Prevention Agency has distributed variant strains," adding, "We will first complete the development of vaccines currently under development and, based on this, quickly develop vaccines responding to variants."

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