International Vaccine Institute to Start First COVID-19 Vaccine Clinical Trial in Korea
The International Vaccine Institute (IVI) and Seoul National University Hospital (SNUH) announced on June 4 that they have signed an agreement to start phase 1 and 2 clinical trials for a COVID-19 vaccine from Inovio Pharmaceuticals of the United States.
The trials are the first clinical study on a COVID-19 vaccine approved in Korea. The two organizations will jointly assess the safety, tolerability, and immunogenicity of the vaccine candidate, INO-4800.
They will first verify the safety of the vaccine by administering it to 40 healthy adults aged 19-50 years and test its tolerability and immunogenicity in an additional 120 people aged 19-64 years.
The clinical trials are funded by the Coalition for Epidemic Preparedness Innovations (CEPI), a foundation that finances independent research projects to develop vaccines against emerging infectious diseases.
In normal circumstances, it generally takes several years to start clinical trials of a new vaccine. Yet the IVI and SNUH could start their trials just two months after clinical trials for the same vaccine candidate began in the United States in April 2020.
The IVI said that Korea has been chosen as one of the countries that start clinical trials on a fast track for an early development of a COVID-19 vaccine. The other countries include the United States, China, the United Kingdom and Germany.
“We will get the results of the phase 1 clinical trial in the United States soon and expect phase 2 and 3 trials to start in this summer,” said IVI Director-General Jerome Kim.
The Korean Ministry of Drug and Food Safety has introduced a fast-track approval process for clinical trials of COVID-19 vaccines and therapeutics developed with a proven safety platform. The fast-track system approves a clinical trial based on non-clinical and clinical data from existing DNA vaccine platforms.
SNUH Professor Oh Myoung-don, who will lead the research project, said, “Social distancing has its limits in preventing the spread of an infectious disease. We need to develop a vaccine to get back to a normal life.”