Fears of Covid-19 resurgence are spreading, but SK Bioscience has yet to apply for a lot release of SKYCovione, the first homegrown Covid-19 vaccine.
On Wednesday, SK Bioscience confirmed SKYCovicone’s immune response to the Omicron variant BA.1 in extended phase 1 and 2 trials.
The company gave two doses of the vaccine to 81 healthy adults and administered a booster shoot after seven months.
The results showed that the neutralizing antibody titers against the Omicron variant BA.1 were 25 times higher right after the second dose and 72 times higher than the titers seven months after the second dose.
"Amid the rising possibility of the Covid-19 resurgence this summer, we have high expectations that the Korean-made vaccine could be a new key to quarantine,” SK Bioscience said.
The company obtained the permit for SKYCovione on June 29 and agreed with the government to supply 10 million doses first.
However, SK Science has not applied for a lot of releases of SKYCovione yet.
The national lot release system ensures the Ministry of Food and Drug SAfety’s quality control of biologics before each lot of product is marketed. It is a must procedure for SK Bioscience to supply the vaccine at home and abroad.
“The company has yet to apply for a national lot release of the vaccine,” an official at the MFDS said. “It usually takes two to three months for lot release approval. But we make it within 15 days if the product is Covid-19 related.”
An official at SK Bioscience also said the company has yet to seek the vaccine’s lot release.
“We plan to do so in line with the Ministry of Health and Welfare’s schedule for SKYCovione supply,” the official said.
Given the time required for a national lot release, the local supply of SKYCovione may not occur within July.
The official explained that the company aimed to win the license in the first half and supply the vaccine in the second half.
The MFDS and the company were reluctant to pinpoint the schedule for the vaccine lot release.
plans by health authorities, including the Korea Disease Control and Prevention Agency (KDCA), subject to change depending on a resurgence situation, are likely to affect the market release of SKYCovione, observers said.
SK Bioscience said it would also conduct the current phase 3 extended trial and another booster shot study on recipients of other Covid-19 vaccines to confirm the vaccine’s effectiveness against other Omicron subvariants.