2 Million Doses Scheduled for Domestic Introduction This Month
The Novavax COVID-19 vaccine 'Nuvaxovid Prefilled Syringe' is being produced at the SK Bioscience L-House Vaccine Center in Andong-si, Gyeongbuk.
[Asia Economy Reporter Lee Chun-hee] SK Bioscience's Novavax vaccine 'Nuvaxovid Prefilled Syringe,' which is contractually developed and manufactured (CDMO) domestically, will be introduced in Korea on the 9th. Health authorities plan to start vaccinating unvaccinated individuals with the Novavax vaccine within this month.
The Ministry of Food and Drug Safety announced on the 8th that it has granted the first national release approval for 840,000 doses of Nuvaxovid Prefilled Syringe. National release approval is a system that comprehensively evaluates the test results by manufacturing lot and the manufacturer's manufacturing and testing results to confirm quality once more before the vaccine is distributed in the market. A representative from SK Bioscience stated, "Starting tomorrow (the 9th), the Novavax vaccine will be shipped from the Andong L-House Vaccine Center," adding, "An initial supply of 2 million doses is planned for this month."
Nuvaxovid Prefilled Syringe is a recombinant protein vaccine developed by Novavax in the U.S. and manufactured from raw material to finished product by SK Bioscience. It induces antibody production in the body by directly injecting antigen proteins made using recombinant technology. This method has been traditionally used in various vaccines such as influenza, hepatitis B, and cervical cancer.
Our government signed a contract last year to receive 40 million doses of Novavax COVID-19 vaccine, but since domestic approval was not granted, the entire quantity has been deferred to this year. SK Bioscience holds all domestic production and commercialization rights. SK Bioscience signed a CDMO contract with Novavax in August 2020 and later, in February last year, also signed a technology transfer contract to produce both raw materials and finished pharmaceuticals.
Notably, while Novavax vaccines are mostly distributed overseas in vials containing 10 doses, SK Bioscience's Nuvaxovid Prefilled Syringe has been improved through additional R&D to a single-dose prefilled syringe form containing one dose per vaccine. This eliminates the need for dilution or aliquoting procedures, freeing it from concerns about contamination during these processes and reducing the workload for medical personnel. This is unique among vaccines currently approved in Korea, including AstraZeneca (AZ), Pfizer, Moderna, Janssen, and Novavax. Other vaccines are all packaged in multi-dose vials and administered by aliquoting the doses.
The Novavax vaccine supplied domestically will initially be used for unvaccinated individuals who have not yet received their primary vaccination. Since concerns about side effects are low, it is expected to improve vaccination rates by enabling basic vaccination for those who have refused vaccination due to concerns about side effects from viral vector (AstraZeneca, Janssen) or messenger RNA (mRNA, Pfizer, Moderna) vaccines.
The government plans to start vaccinating high-risk unvaccinated individuals who have not received their first or second doses among patients in nursing hospitals, facilities, and medical institutions within this month, and then expand the vaccination target to the general unvaccinated population. Third and heterologous booster vaccinations are also currently under consideration for those who experienced adverse reactions after the first or second doses and are reluctant to receive additional vaccinations.
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