The Ministry of Food and Drug Safety released the results of the expert review on SK Bioscience’s SKYCovione (pipeline name: GBP510), the nation’s first homegrown Covid-19 vaccine, and said the data was sufficient to confirm approval.

However, some criticized the government, saying it unfairly and prematurely supported SK Bioscience by officially announcing the approval decision before the vaccine candidate goes through the ministry’s final review committee.

On Monday morning, the MFDS held an online briefing to release the outcome of the review of marketing approval for SKYCovione, one day after holding the Central Pharmaceutical Review Committee.

“We discussed whether to recognize this vaccine’s safety and effectiveness and concluded that it could obtain approval, based on the results of the immunogenicity clinical trial that compared the vaccine with the existing Vaxzevria,” said Oh Il-hwan, leader of the Central Pharmaceutical Review Committee.

Oh said that adverse events during the clinical trial were at permissible levels.

However, he said that adverse reactions predicted locally and systemically were likely to occur after the first dose, rather than the second, and among young adults rather than the elders. These side effects included fatigue, muscle pain, headache, chills, fever, joint pain, nausea/vomiting, and diarrhea. Therefore, he said doctors should notify this before administering the first dose.

The MFDS said it would comprehensively judge expert opinions on the efficacy and recommended dose and hold the final review committee to decide on whether to approve.

The problem, however, is that the MFDS made it almost official to approve SKYCovione only with the latest review results.

Asked when the exact date of the final marketing approval will be, National Institute of Food and Drug Safety Evaluation Director General Seo Kyung-won said she could not predict the date because the final review committee has yet to open.

“But if possible, we are making efforts to approve it within this month,” she said.

Her comments hint that the MFDS already decided to grant the nod for SKYCovione.

Seo elaborated that her prediction for “approval within this month” included the meeting of the final review committee, which shows the government’s will to advance the approval date.

“SKYCovione is meaningful because it is the first homegrown Covid-19 vaccine that was developed from the raw material to the finished product,” Seo said.

For SKYCovione to be used for vaccination, SK Bioscience has to prove the results of the ongoing clinical trial of a booster shot after obtaining the marketing permit.

Reporters asked whether SK Bioscience’s vaccine could be used for the fourth vaccination in preparation for seasonal outbreaks of Covid-19 this autumn.

In reply, “We need to discuss this with the Korea Disease Control and Prevention Agency,” she said.

Sixteen external experts attended the Central Pharmaceutical Review Committee meeting -- 11 standing members of the biopharmaceutical subcommittee for the review of the vaccine’s safety and effectiveness, four advisory group experts to verify the safety and efficacy, and one expert recommended by the Korean Medical Association.

Also, seven from the MFDS’ Covid-19 crisis response support team attended the meeting.

When reviewing a Covid-19 vaccine or treatment, the MFDS goes through consultations from three groups -- the Covid-19 vaccine safety/efficacy verification advisory group, the central pharmaceutical review committee, and the final review committee.

According to the MFDS, unpredicted adverse events related to the vaccine occurred in 13.3 percent of the vaccine group. Major side effects included pruritus at the injection site, dizziness, and pain. In the control group, such reactions occurred about 14.6 percent, which was no different from the vaccine group.

Serious adverse reactions occurred in 0.5 percent in the vaccine group and 0.5 percent in the control group.

There was one serious adverse event of rapidly progressive glomerulonephritis which could not be excluded from association with the vaccination.

Regarding efficacy, SKYCovione-vaccinated people aged 18 or older formed 2.93 times higher neutralizing antibody titer 14 days after two doses with a four-week interval than Vaxzevria, the control vaccine. In addition, the seroconversion rate was 98.06 percent in the vaccine group and 87.3 percent in the control group.