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President Moon Jae-in on Aug. 10 said he hopes that the first domestically made vaccine by SK Bioscience can be both "born and commercialized." The photo shows the president in October last year observing microscopic cells at the company's headquarters in Seongnam, Gyeonggi-do Province.


The Ministry of Food and Drug Safety on Aug. 10 approved SK Bioscience's bid to conduct the third phase of clinical trials for its COVID-19 vaccine candidate GBP510.

SK is thus the first domestic pharmaceutical maker to enter the third phase of clinical trials for a vaccine against the coronavirus.

Made with gene recombination technology, GBP510 is a recombinant vaccine injected with COVID-19 surface antigen protein that provokes an immune reaction.

In a news release on the same day, SK said, "We are monitoring the safety of 247 participants, including elderly people, who participated in the second phase of clinical tests and got their second shots in late June this year."

"We have had no particular safety issues so far."

Phase 3 trials will have 3,990 adults aged 18 or over take part to test GBP510's immunogenicity and safety. Testing is slated not only in Korea but also in other regions including countries in Southeast Asia and Eastern Europe.

The ministry said, "This approval of the clinic trials is meaningful as the first step for the commercialization of domestically made vaccines."

"By the first half of next year, we aim to produce mid-term analysis results of the third-phase clinical trials, and after applying for approval, our goal is to commercialize the vaccine in the first half of 2022."

President Moon Jae-in on the same day expressed his hope for the development of domestically made vaccines.


In a written briefing by Cheong Wa Dae Spokesperson Park Kyung-mee, the president was quoted as saying, "I hope the first domestically made vaccine can be born and commercialized," adding, "The government will provide support at all levels so that the clinical trials are carried out sufficiently and swiftly."


Korea.net