SK bioscience's Covid-19 vaccine clears major hurdle
That's the second hurdle SKYCovione cleared to get formal use approval, and the toughest. The Ministry of Food and Drug Safety reviews drug candidates in three phases, so only one remains.
"Based on the overall data regarding safety and efficacy, the CPAC advised that we could approve the use of SKYCovione," the Ministry of Food and Drug Safety said Monday.
The review was done by 12 outside experts and seven experts from the ministry.
According to the data, SKYCovione had 2.93 times more neutralizing antibodies titers against the virus than AstraZeneca's vaccine. It also demonstrated higher immunogenicity.
SKYCovione's Phase 3 clinical trials were comparative-style trials, which compare the immunogenicity of an already-authorized vaccine with a candidate under development in order to prove its efficacy. Patients received two doses of 0.5 milliliters (0.017 ounces) at four-week intervals.
In regards to safety, the number of patients experiencing side effects was similar among the SKYCovione group and the AstraZeneca group.
"The side effect issues showed in the trials were allowable," the CPAC said.
But the side effects were more in the first dose, and more for young people than older people, so guidance will be necessary before administrating the vaccines, it added.
The drug ministry is expected to announce a final decision by the end of the week.
BY SARAH CHEA [email@example.com]