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The first domestic vaccine for COVID-19 passed the advice of the Central Pharmacist Review Committee for product approval.
The Food and Drug Administration is expected to make a final approval within this week.
Correspondent Kim Deok-hyun.
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SK Bioscience's SK Bioscience, the first domestically developed coronavirus vaccine, has passed the advice of the Central Pharmacist Review Committee, an advisory body of the Ministry of Food and Drug Safety.
The Central Pharmacopoeia is the second stage of the triple advisory process for coronavirus vaccines and treatments.
As a result of comparing with the previously licensed AstraZeneca vaccine, Skycobi One Multi was found to be highly effective.
The titer of the neutralizing antibody, which can neutralize the coronavirus and prevent infection, was 2.93 times that of the control group, AstraZeneca, when inoculated twice at an interval of 4 weeks for adults.
However, the JoongAng Medical Center predicted that adverse reactions such as fatigue, muscle pain, and headache may occur after receiving this vaccine.
[Oil-hwan/Chairman of the Central Pharmacist Review Committee: Adverse reactions were more severe after the first administration than during the second administration, especially in young adults than the elderly (the incidence was high)]
One serious adverse drug reaction was confirmed, but currently He said he was recovering, and the safety was judged to be acceptable.
The Ministry of Food and Drug Safety plans to hold the final inspection committee, the final advisory stage, within a few days to decide whether to approve the product.
After that, the government is planning to introduce 10 million domestic vaccines within this year.
Meanwhile, yesterday (26th), there were 3,429 new confirmed cases of Corona 19, keeping it below 10,000 for the 18th day.
There were 68 cases of severe serious illness and 3 deaths.