The Ministry of Food and Drug Safety, a government public health agency, said it has approved the manufacturing and sales of SK Bioscience's vaccine codenamed GBP510 as a condition of submitting the final result report of clinical trials.
The green light came after experts evaluated GBP510 in accordance with international screening standards adopted in the United States and Europe, the ministry said, allowing SK Bioscience to promote the registration of WHO's Emergency Use List (EUL) and supply it through COVAX FACILITY, a worldwide initiative aimed at equitable access to COVID-19 vaccines.
Food and Drug Safety Minister Oh Yu-Kyoung said his office has conducted a scientific and thorough examination to confirm the safety and effectiveness of GBP510. "We will work with various institutions in the future to preemptively respond to future infectious diseases," she said in a statement on June 29.
BP510 can be stored in a refrigerator at 2-8 degrees Celsius, so it can be used in countries without ultra-low temperature distribution equipment, the ministry said. Adults aged 18 or older can be inoculated with a 0.5 milliliter (mL) antigen vial mixed with an immune enhancer called "AS03" twice every four weeks.
GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus made using genetic recombination technology to induce an immune response. SK Bioscience has used an adjuvant from GlaxoSmithKline (GSK), a British multinational pharmaceutical company. An adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs.
SK Bioscience said earlier that GBP510 has shown excellent immune responses compared to a COVID-19 vaccine of AstraZeneca PLC, a Swedish-British pharmaceutical company, in clinical trials in South Korea, Thailand, Vietnam, New Zealand, Ukraine, and the Philippines.
The development of GBP510 has been funded by the Coalition for Epidemic Preparedness Innovations (CEPI), an international foundation that finances vaccine research projects. CEPI has launched a Wave 2 project to discover new vaccines with money from the Bill & Melinda Gates Foundation.
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