SK bioscience closer to obtaining approval for COVID-19 vaccine
President-elect Yoon Suk-yeol, second from right, greets employees of SK bioscience at the firm's headquarters in Seongnam, Gyeonggi Province, Monday. SK Group Chairman Chey Tae-won, right, and Presidential Transition Committee Chairman Ahn Cheol-soo, third from right, also attended the event. Yonhap
Yoon vows full support for vaccine development
By Lee Kyung-min
SK bioscience, a local biotech affiliate of SK Group, said Monday that its COVID-19 vaccine candidate GBP510 showed more successful, better immune responses compared to those formed by AstraZeneca's vaccine, when measured by immunogenicity. Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in a human body.
The assessment is backed by the Phase 3 clinical trial of 4,037 adults aged 18 and older in Korea, Thailand, Vietnam, New Zealand, Ukraine and the Philippines.
This is the latest development in the yeas-long effort to develop and commercialize a domestic COVID-19 vaccine, a step toward strengthening the country's vaccine sovereignty. Apart from the synthetic antigen vaccine, the SK affiliate is also developing an antiviral spray.
Neutralizing antibodies formed by GBP510 were, the trial results showed, stronger and more effective in preventing infections, compared to the control vaccine, Vaxzevria, developed and manufactured jointly by AstraZeneca and the University of Oxford, the firm said.
The number of people whose neutralizing antibodies increased fourfold after GBP510 injection was higher than those in the control group, which SK bioscience said is a statistically meaningful result.
SK bioscience will file a request with the Korea Disease Control and Prevention Agency (KDCA) for a drug manufacturing license for GBP510, after securing safety efficacy data. The KDCA is conducting a preliminary review of the vaccine candidate, with final approval expected before July.
“We will file the request with the KDCA soon,” an SK bioscience spokesperson said. “We will achieve a new milestone in global containment efforts with the successful development of GBP510, thereby elevating the country's standing on the global stage.”
Earlier in the day, President-elect Yoon Suk-yeol visited the headquarters of the SK affiliate in Seongnam, Gyeonggi Province, and expressed gratitude to company employees for the successful development of the vaccine.
“I highly appreciate the efforts of SK bioscience officials whose collective sense of duty has led to the enhanced safety and security of the country,” he said.
Yoon said the incoming administration will establish a committee whereby health authorities and the private sector will cooperate to foster the innovation of the bio and pharmaceutical industries. The move seeks to strengthen the healthcare industry as the new growth driver in the same way the government has nurtured the country's semiconductor industry.
GBP510 is being developed jointly by the SK affiliate and the Institute for Protein Design (IPD) under the University of Washington. Research funds were provided by the Bill & Melinda Gates Foundation, a private foundation.
The vaccine candidate features the characteristics of an “adjuvant technology” by GlaxoSmithKline, a U.K.-headquartered pharmaceutical firm. GlaxoSmithKline says adjuvant is added to some vaccines to “enhance the immune response, thereby creating a stronger and longer-lasting immunity against infections than the vaccine alone.”
The clinical trials are overseen by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. and the World Health Organization (WHO).