COVID-19 Vaccine Clinical Trial Participants Exempted from 'Quarantine Pass' Requirement

At Busan Dong-A University Hospital, administration of the COVID-19 vaccine candidate 'GBP510' by SK Bioscience is underway for the Phase 3 clinical trial participants. (Photo by SK Bioscience)

[Asia Economy Reporter Chunhee Lee] Participants in clinical trials for domestically developed COVID-19 vaccines are exempt from the application of the 'Quarantine Pass (vaccination certificate/negative test confirmation system)'.

Park Hyang, head of the Central Disaster and Safety Countermeasures Headquarters' quarantine team, stated at a regular briefing on the morning of the 15th, "We recognize exceptions to the quarantine pass for clinical trial participants." This announcement follows the 'Measures to Strengthen Support for COVID-19 Vaccine and Therapeutic Clinical Trials' released by the Central Disaster and Safety Countermeasures Headquarters on the same day. Currently, eight companies in Korea are conducting clinical trials for COVID-19 vaccines, and sixteen companies are conducting clinical trials for COVID-19 therapeutics.

For participants in phase 3 of the COVID-19 vaccine clinical trial currently conducted by SK Bioscience, vaccination certificates are being issued. However, participants in phases 1 and 2 faced issues as they could not receive separate vaccinations and thus could not use the quarantine pass.

Accordingly, from this month, phase 1 and 2 participants who submit a clinical trial participation certificate issued by the National Clinical Trial Foundation to public health centers will be issued a 'Vaccination Certificate Negative Test Confirmation Exception Certificate' that recognizes an exemption from the quarantine pass.

Additionally, for COVID-19 confirmed patients wishing to participate in therapeutic clinical trials, institutional improvements will be promoted to facilitate easier participation. Park explained, "At the stage of hospital bed allocation by public health centers, we plan to confirm the willingness to participate in clinical trials and prioritize allocation to hospital beds at clinical trial institutions." Subsequently, participants assigned to clinical trial institutions will undergo consultation and consent procedures regarding the clinical trial through the responsible medical staff before participating in the trial.

Meanwhile, to expedite clinical progress, the Clinical Trial Support Organization (SMO), which supports external experts, will be allowed to autonomously perform delegation contracts. Whereas previously SMOs contracted with the heads of clinical trial institutions (hospital directors), going forward, SMOs will be able to contract with pharmaceutical companies or clinical trial principal investigators.

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