MFDS Grants First Approval for SK Bioscience's Domestic 'COVID-19 Vaccine'
Triple Advisory Process Ensures Review Expertise and Transparency
Securing 'Vaccine Sovereignty' and Contributing to Global Health Security
[Asia Economy Reporter Jo In-kyung] The COVID-19 vaccine developed by SK Bioscience has received final product approval. With the birth of the first vaccine developed using domestic technology, South Korea has joined the ranks of countries developing COVID-19 vaccines.
On the afternoon of the 29th, Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety (MFDS), held a briefing and announced, "We have decided to approve the product license for the COVID-19 vaccine 'Skycovione Multi (GBP510)' developed, manufactured, and marketed by SK Bioscience."
Commissioner Oh explained, "Now, South Korea has become a country possessing both COVID-19 therapeutics and vaccines, following the United States and the United Kingdom," adding, "We have established a health and security system that can respond more proactively to future infectious disease outbreaks."
'The First Domestic' COVID-19 Vaccine Secures Efficacy and Safety
Skycovione Multi is a COVID-19 vaccine that induces an immune response by administering an antigen protein created using recombinant gene technology. It is approved for the prevention of COVID-19 in adults aged 18 and over. A 0.5 ml dose, which is a mixture of the antigen vial and the adjuvant (AS03) included, is administered twice at 4-week intervals.
Previously, experts judged that the vaccine’s safety was generally favorable as most adverse events were predictable, and its efficacy was sufficient when compared to AstraZeneca’s immunogenicity.
On the day of approval, the MFDS’s final review committee decided to grant product approval for Skycovione Multi and requested SK Bioscience to submit the final clinical trial report. Commissioner Oh stated, "The final review committee mandated that through a risk management plan after approval, ongoing clinical trials and adverse events occurring during post-approval use be collected and evaluated."
The Vaccine First Approved Worldwide by South Korea’s MFDS
This approval is significant in that the MFDS conducted evaluations of safety, efficacy (immunogenicity), and quality according to international review standards throughout the entire process?from development stage, clinical trials, production management, to final approval?for a COVID-19 vaccine developed by a domestic company. Despite the COVID-19 situation, the MFDS operated the 'Our Vaccine Project' and a dedicated pre-approval review team to provide focused and systematic support to expedite vaccine development.
Prior to product approval, the vaccine underwent a triple advisory process including the ▲COVID-19 Vaccine Safety and Efficacy Verification Advisory Group, ▲Central Pharmaceutical Review Committee, and ▲Final Review Committee. Additionally, while conducting approval reviews, testing methods necessary for quality control were established, and preparations were completed to ensure timely supply of the COVID-19 vaccine through rapid and thorough national lot release approval upon SK Bioscience’s application.
The MFDS explained, "As a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), we reviewed the non-clinical, clinical, and quality data of Skycovione Multi under approval requirements and review standards equivalent to those of advanced countries such as the United States and Europe."
Whole-of-Government Collaboration for the Birth of the First Domestic COVID Vaccine
Not only the MFDS but also vaccine developers, government agencies, research institutes, and private experts joined forces. The Ministry of Science and ICT supported essential preclinical procedures before clinical trials, including ▲efficacy evaluation of vaccine candidates and ▲preclinical trials (animal testing, toxicity evaluation, etc.) in collaboration with the Korea Research Institute of Bioscience and Biotechnology, Korea Research Institute of Chemical Technology, Korea Institute of Toxicology, Institut Pasteur Korea, and the National Mouse Phenotyping Center.
The Ministry of Health and Welfare, together with the Korea Disease Control and Prevention Agency and the National Clinical Trial Center, rapidly expanded related systems and infrastructure such as ▲operation of the National Infectious Disease Clinical Trial Center, ▲recruitment and priority linkage of prospective clinical trial participants, ▲establishment of a clinical trial participation certificate system and various incentives, and ▲provision of vaccination certificates for participants in phase 3 clinical trials.
In particular, the government supported securing comparator vaccines through negotiations with international organizations such as the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI), as well as overseas pharmaceutical companies, to expedite the final phase 3 clinical trials. It also supported priority linkage of domestic clinical trial volunteers and one-on-one matching with overseas diplomatic missions to assist overseas clinical trials.
The Korea Disease Control and Prevention Agency’s National Institute of Infectious Diseases and the International Vaccine Institute utilized the public vaccine development and support center infrastructure to rapidly analyze specimens collected from clinical trials. Additionally, to expand vaccine production capacity, a pre-purchase contract for 10 million doses was signed in January.
Will the Domestic Vaccine Enter the Global Market?
Currently, the product approval for Skycovione Multi covers only the primary 1st and 2nd doses of the COVID-19 vaccine. It has not yet been decided whether it will be used for additional booster shots to prepare for a COVID-19 resurgence this fall.
Commissioner Oh said, "Clinical trials for additional doses are currently underway, and plans for booster shots will be made after comprehensive evaluation of clinical efficacy, safety, and necessity in consultation with health authorities," adding, "Research is still ongoing on whether this vaccine is effective against the recently spreading Omicron variant."
This product approval also raises expectations for domestic companies’ entry into the global vaccine market. SK Bioscience plans to pursue listing on the WHO Emergency Use Listing (EUL) and prepare vaccine supply through the COVAX Facility (an international vaccine supply project). Notably, this vaccine can be stored refrigerated (2?8℃), making it effective for use in countries lacking ultra-cold chain distribution equipment.
Lee Ki-il, 2nd Vice Minister of the Ministry of Health and Welfare, stated, "Although additional research remains, such as verifying efficacy for heterologous/booster doses and the Omicron variant, the development of the first domestic COVID-19 vaccine is significant as it secures vaccine sovereignty for Korea," adding, "We will actively support overseas expansion as well as domestic vaccination with this vaccine developed by our company to contribute to global health security."
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