South Korea approves first homegrown Covid-19 vaccine
South Korea has authorised its first homegrown Covid-19 vaccine, finally securing vaccine sovereignty almost 30 months after the pandemic began.
The government on Wednesday announced the official approval of SkyCovione, a recombinant protein-based vaccine developed by SK Bioscience after a final examination committee held a meeting to review the previous assessments earlier in the day.
“The Food and Drug Safety Ministry thoroughly verified the vaccine’s safety and efficacy through a three-step consultative process and approved SK Bioscience’s SkyCovione,” said Food and Drug Safety Minister Oh Yu-kyoung.
The ministry said it had decided to grant approval under the condition that SK Bioscience submits the final report of its clinical trials. SkyCovione has been authorised for two administrations with a four-week interval in people aged 18 or older.
Oh said the country now has set up a health security system that can preemptively respond to future pandemics.
The official approval came two days after the Central Pharmaceutical Affairs Council recommended the approval of the country’s first homemade Covid-19 vaccine. The CPAC on Monday confirmed that SkyCovione showed immunogenic superiority when compared to the control vaccine of Vaxzevria with an acceptable safety level based on data from clinical trials.
The Korea Disease Control and Prevention Agency signed a pre-purchase contract with SK Bioscience to buy 10 million doses of the vaccine in March.
SK Bioscience is expected to begin rolling out the vaccine in the second half of the year as the local drug maker looks to target overseas markets with lower vaccination rates.
“SkyCovione has its proven safety verified as it was developed as a synthetic antigen vaccine. It also has the advantage of being able to be stored and distributed at room temperatures,” an SK Bioscience official told The Korea Herald.
“Based on this, we will supply the vaccine to developing countries with lagging vaccination rates through the World Health Organisation’s Covax facility. We will also utilise SkyCovieone’s platform to develop vaccines against other variants,” the official added.
According to the government, there are six other companies still in the process of developing their own Covid-19 vaccines while 18 companies are trying to develop Covid-19 treatments.
The government said it will continue to support them so that there can be second and third homemade vaccines and treatments.
The Korea Herald
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