DOMESTIC VACCINE GOES INTO 3RD CLINICAL TRIAL

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A COVID-19 vaccine candidate being developed by a South Korean firm will enter phase three clinical trial for the very first time. It marks the first step toward vaccine self-sufficiency. The goal is to roll out the vaccine in the first half of next year.

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SK Bioscience’s COVID-19 vaccine candidate set to enter the phase 3 clinical trial is similar to the vaccines for hepatitis B or cervical cancer. The candidate is a recombinant-protein vaccine where spike protein is injected into the body with immune boosters for the formation of neutralizing antibodies. According to phase 1 trial interim results carried out on 80 adults, more than five fold the amount of antibodies were formed in them, compared to a fully recovered Covid-19 patient. No serious side effects were reported. In phase 2 trials which also included senior citizens, no major safety concern has been detected so far.

[Soundbite] Kim Gang-lip(Minister of Food and Drug Safety) : "The first phase 3 trial for a domestic vaccine marks the first step to achieving vaccine self-sufficiency."

Phase 3 will be conducted in a comparison trial due to difficulty securing a large number of trial subjects. The candidate will be compared with the AstraZeneca vaccine to assess the formation of neutralizing antibodies. Around 3,990 people in South Korea, Southeast Asia and Eastern Europe will take part in the trial. The target release date for the vaccine is sometime in the first half of next year.

[Soundbite] Kim Hun(CTO, SK Bioscience) : "The last trial will take place in the fastest and safest manner in Korea and other countries as we seek to obtain final approval in the first half of 2022."

Ten local firms are currently developing a COVID-19 vaccine. The Food and Drug Safety Ministry vows to continue support so that other candidates can also enter phase 3 trial.