Supply of 10 Million Doses of Novavax by Q3... Active Support for Domestic Vaccine Development

Novavax Vaccine Production to Start This Month
Finished Products Released in June... Targeting Supply for 10 Million Doses in Q3
GC Green Cross Applies for Moderna Vaccine Approval... Plans to Import 20 Million Doses

President Moon Jae-in is attending the 'Special COVID-19 Response Quarantine Inspection Meeting' held at the Yeomin Building of the Blue House on the afternoon of the 12th. [Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] In South Korea, 10 million doses (20 million shots) of the Novavax COVID-19 vaccine will be produced domestically by the third quarter. In addition, the government is accelerating the confirmation of supply schedules for vaccines that have not yet been introduced and plans to actively support the development of domestic vaccines.

President Moon Jae-in chaired the "Special COVID-19 Response Quarantine Inspection Meeting" on the afternoon of the 12th at the Yeomin 1 Hall video conference room in the Blue House, stating, "Domestic production of the Novavax vaccine will begin this month," and added, "Finished products will be released starting in June, and 20 million doses will be supplied to our citizens by the third quarter."

According to the "COVID-19 Vaccine Introduction Strategy and Domestic Vaccine Development Support Plan" reported to President Moon by the Ministry of Health and Welfare on the same day, a total of 79 million doses (152 million shots) of COVID-19 vaccines are scheduled to be supplied domestically within this year. As of the 12th, 1.6865 million doses (3.373 million shots) have been introduced, accounting for 2.13% of the total planned supply. The government plans to carry out vaccinations for 12 million people as planned in the first half of the year using 18.088 million confirmed doses of vaccines.

Furthermore, the government aims to finalize the vaccine supply schedule within the first half of the year to enable more citizens to receive COVID-19 vaccinations and actively secure additional quantities. It also plans to simplify administrative procedures for vaccine introduction, support the supply of vaccine raw materials and components, and resolve difficulties through the "Pan-Government Vaccine Introduction Task Force."

Minister of Health and Welfare Kwon Deok-cheol said at a briefing, "We are conducting relay meetings directly with representatives of vaccine suppliers such as Pfizer, Novavax, AstraZeneca, Janssen, and Moderna," and added, "Considering the expansion of vaccination age, antibody maintenance period, and variant viruses, we are keeping the possibility of additional vaccine purchases open and will actively negotiate with suppliers to enable earlier vaccine introduction."

In January, President Moon Jae-in visited the SK Bioscience factory in Andong, Gyeongbuk, holding a COVID-19 vaccine produced there. [Image source=Yonhap News]

The government announced that domestic production of the Novavax COVID-19 vaccine has begun through these efforts. Earlier in February, the government signed a contract for 20 million doses (40 million shots) of the Novavax vaccine. However, due to the U.S. export control administrative order (HRPAS) and global raw material supply imbalances, there were disruptions in the supply of raw materials and components for domestic production of the Novavax vaccine.

In response, the government operated the "Novavax Raw Material Supply Council," which includes the Ministry of Health and Welfare, Korea Disease Control and Prevention Agency, Ministry of Foreign Affairs, Ministry of Trade, Industry and Energy, Ministry of SMEs and Startups, Ministry of Food and Drug Safety, and SK Bioscience, meeting once a week to actively address the issue. Through this, supply problems for a total of 17 items were mostly resolved, and production is expected to start this month with finished products possibly released as early as June.

SK Bioscience expects that the Novavax vaccine will receive product approval in the first half of the year, and based on additional procurement of raw materials and components and increased yield, production of up to 10 million doses (20 million shots) by the third quarter is possible. Minister Kwon explained, "This quantity will be produced under a license transfer method and will be entirely supplied domestically." The Ministry of Food and Drug Safety also announced plans to expedite the approval process through prior review if necessary documents for Novavax vaccine approval are submitted.

Meanwhile, GC Green Cross, responsible for domestic distribution of the Moderna vaccine, applied to the Ministry of Food and Drug Safety for import product approval of the Moderna vaccine on the same day. The Moderna vaccine, developed on the same messenger RNA (mRNA) platform as the Pfizer vaccine, is administered in two doses 28 days apart. Currently, 20 million doses (40 million shots) are scheduled for introduction, and last year Moderna announced plans to supply its vaccine to South Korea starting in May.

The government is also strengthening support for the development of domestic COVID-19 vaccines. Currently, five companies including SK Bioscience, UbioLogics, Cellid, Genexine, and GeneOne Life Science are conducting clinical trials domestically, aiming to start phase 3 clinical trials in the second half of the year.

To support clinical trial costs, the government is investing 68.7 billion KRW this year and will facilitate the rapid establishment and utilization of immune correlates of protection (ICP) to ease difficulties in recruiting large-scale clinical trial participants. ICP analyzes the correlation between immunogenicity (antibody levels and duration) induced by the vaccine and protective effects, enabling trials with fewer subjects and lower costs. The Ministry of Food and Drug Safety estimates that while traditional phase 3 trials require 30,000 participants and cost between 400 billion to 1.2 trillion KRW, using ICP could reduce this to 4,000?6,000 participants and 80 to 120 billion KRW.

The government is also pursuing the acquisition of mRNA vaccine development technology to respond to potential future emerging infectious diseases. A public-private joint "mRNA Expert Committee" will be operated, and support for securing foundational technology through cross-ministerial collaboration will be strengthened. Additionally, international cooperation for research and technology acquisition will be pursued, including the signing of a memorandum of understanding (MOU) between the National Institute of Infectious Diseases and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), and the formation of a Korea-Germany health sector consultative body.

Celltrion's antibody treatment 'Rekkironaju'
[Image source=Yonhap News]

In the therapeutic field, the scope of approval for Celltrion's antibody treatment "Rekkironaju" will be expanded, and early introduction of overseas-developed therapeutics will be promoted. Currently, Rekkironaju is conditionally approved for phase 3 trials with limited use for elderly patients and those with cardiovascular or respiratory diseases.

Kim Gang-rip, head of the Ministry of Food and Drug Safety, stated, "Considering recommendations from the European Medicines Agency (EMA) and expert consultations, we will support expanding the phase 3 clinical trial target range of Rekkironaju to include patients with heart disease, cancer, immunosuppression, and obesity," adding that this will facilitate expanded use and timely treatment support through shortened administrative procedures for emergency use approval. He also said that for overseas-developed therapeutics, early clinical information will be reviewed in advance and active communication will be maintained to enable rapid introduction into the country.

The government will also support the rapid introduction of self-test kits. To increase the possibility of kit development, cooperation among related ministries will be strengthened to shorten the typical 8-month product development period to within 2 months by preparing self-test guidelines, conducting pre-approval reviews and consultations by dedicated examiners, and supporting clinical specimen collection through connections with residential treatment centers and clinical institutions.

Until domestic self-test kits are developed, the government plans to promptly respond to changes in the testing system by evaluating products approved for professional use domestically but used personally overseas under emergency use authorizations, and conditionally approving them upon submission of domestic clinical data.

Enforcement of quarantine measures will also be strengthened. The Ministry of the Interior and Safety announced that through the "Plan to Strengthen Enforcement of Quarantine Measures," a joint government-local government quarantine inspection team will be formed to focus inspections on vulnerable facilities, and a zero-tolerance policy will be applied to quarantine violations.

The joint government quarantine inspection team will begin focused inspections on the 15th targeting the "9 major vulnerable facilities" where cluster infections have recently been frequent (academies, religious and sports facilities, daycare centers and bathhouses, construction sites, door-to-door sales facilities, entertainment venues, restaurants, and cafes). Risk assessments of 17 cities and provinces will be conducted, and inspections will prioritize areas with higher risk to minimize quarantine blind spots.

If violations of quarantine rules are detected during inspections, a zero-tolerance policy will be applied, and strict measures such as closure orders and fines under the Infectious Disease Control and Prevention Act will be enforced.

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