SEOUL (Reuters) - South Korea approved its first domestically developed COVID-19 vaccine, manufactured by SK bioscience Co Ltd, for general public use following positive clinical data, authorities said on Wednesday.
The SKYCovione vaccine was authorised for a two-dose regimen on people aged 18 or older, with shots given four weeks apart, according to the Ministry of Food and Drug Safety.
In a phase III clinical trial of 4,037 adults, SKYCovione induced neutralizing antibody responses against the SARS-CoV-2 parental strain, SK bioscience said in a statement.
It is not yet known how effective it is against Omicron and other COVID variants.
The vaccine was jointly developed by the University of Washington's Institute for Protein Design, with the support of global drugmaker GlaxoSmithKline (GSK) and the Coalition for Epidemic Preparedness Innovations (CEPI).
The vaccine is based on a "self-assembled nanoparticle" protein subunit targeting the SARS-CoV-2 receptor-binding domain, and includes GSK's squalene-based "pandemic adjuvant" AS03, which has been used previously in licensed flu vaccines.
SK bioscience said it would seek authorisations for distribution of SKYCovione in other countries and through global vaccine sharing facility COVAX, and for emergency use listing at the World Health Organization.
South Korean authorities have agreed a 200 billion won ($155 million) deal to buy 10 million doses of the vaccine, which can be stored under normal refrigeration conditions, and previously said they expected it to be rolled out from the second half of the year.
SK bioscience is now looking into its possible use for booster shots, and planning trials for adolescents and children, it added.
Nearly 87% of South Korea's 52 million population are fully vaccinated, with 65% having also had a booster shot, according to the Korea Disease Control and Prevention Agency data.
($1 = 1,293.2800 won)
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