'Kuksan 1ho' Domestic COVID-19 Vaccine Supply... Will Additional Development Gain Momentum?

SK Bioscience Signs Pre-Purchase Contract for 10 Million Doses of 'GBP510' with KDCA
Cross and Booster Vaccination Trials Underway

Comparator Vaccine Usable... Boosts Domestic Additional Vaccine Development

Last year, subject administration for the Phase 3 clinical trial of SK Bioscience's COVID-19 vaccine candidate 'GBP510' was underway at Busan Dong-A University Hospital. (Photo by SK Bioscience)

[Asia Economy Reporter Lee Chun-hee] With the domestic supply of the COVID-19 recombinant protein vaccine ‘GBP510’ developed by SK Bioscience secured, it is expected that additional development of domestically produced vaccines will gain momentum. In particular, once the first domestic vaccine is created, it is anticipated to have a positive impact by being used as a control group in future clinical trials.

According to the pharmaceutical and biotech industry on the 23rd, SK Bioscience recently signed an advance purchase agreement with the Korea Disease Control and Prevention Agency (KDCA) to supply 10 million doses of GBP510 domestically. The total contract value is 200 billion KRW, which equates to about 20,000 KRW per dose.

However, GBP510 is still an unapproved vaccine. Currently, a global Phase 3 clinical trial involving approximately 4,000 participants is underway. SK Bioscience plans to obtain domestic approval in the first half of this year and begin domestic supply in the second half. Recently, the company submitted documents related to the ‘rolling review’ to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for UK approval. They also plan to submit a marketing authorization application to the European Medicines Agency (EMA) within the first half of the year.

Considering the already high rates of first and second dose vaccinations domestically, additional clinical trials for heterologous (mix-and-match) and booster vaccinations are also being conducted. SK Bioscience submitted a Phase 3 clinical trial plan (IND) for a booster dose of GBP510 to the Ministry of Food and Drug Safety (MFDS) yesterday. This involves administering GBP510 as a booster three months after the initial dosing to participants from the existing general Phase 3 trial. Booster clinical trials through heterologous vaccination are also being conducted as investigator-initiated studies led by the KDCA.

An SK Bioscience researcher is conducting research for vaccine development.

If the approval and supply of GBP510 are realized, it is expected to greatly support the overall development of domestically produced vaccines. The approval of the first domestic COVID-19 vaccine will energize the entire industry and could also accelerate the clinical trials of other vaccines under development.

Typically, clinical trials compare the condition of a control group receiving a placebo such as saline with an experimental group receiving the actual drug. However, in vaccine trials for infectious diseases like COVID-19, administering a placebo to the control group raises ethical concerns as it exposes them to infection risk, making recruitment for the control group difficult.

To address this, the concept of ‘comparative clinical trials’ was introduced. This method indirectly evaluates vaccine efficacy by comparing a control group vaccinated with an already approved vaccine and an experimental group vaccinated with the candidate vaccine. However, existing vaccine developers have generally been reluctant to provide their vaccines easily to latecomers, as they invested astronomical costs in development. Moreover, all domestically approved vaccines so far have been developed by foreign companies, making it especially difficult to secure control vaccines.

So far, the only case of securing a control vaccine for clinical trials was SK Bioscience’s use of the AstraZeneca (AZ) vaccine for GBP510. This was possible because SK Bioscience was contract manufacturing (CMO) the AZ vaccine, and the Korean government actively requested continuous cooperation from AZ and international organizations such as the World Health Organization (WHO). In the case of Cellid, due to difficulties in securing a control vaccine, the company changed its plan from applying for Phase 2b and 3 trials simultaneously to conducting Phase 2b first.

However, with GBP510 now able to be used as a control vaccine for additional domestic vaccine development clinical trials, such concerns are expected to disappear.

This content was produced with the assistance of AI translation services.