Phase 3 clinical trial of BUMN Covid-19 vaccine estimated to be completed by August

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vaccine
Vaccine illustration. (SirOnline/Aslam Iqbal)

BUMN Covid 19 vaccine is the result of a collaboration between state-owned pharmaceutical holding company PT Bio Farma (Persero) and US-based Baylor College of Medicine. The vaccine has been registered with the WHO as Covid-19 vaccine candidate since June 2021.

Vaccines that use Recombinant Protein Subunit (protein Receptor Binding Domain/RBD) technology have to go through a long process to be approved. Phase one trial to evaluate its safety and preliminary immunogenicity involved 175 subjects above 18 years old.

“Phase one trial started on February 16 and produced good results. Phase two trial to evaluate and select the best vaccine dose to proceed to phase three, with two candidate formulas and involving 360 volunteers aged 18 years and above, started in April 13,” he explained.

Head of the Semarang research team at Diponegoro University, Yetty Movieta Nency, explained that the trial from phase 1-3 took about eight months.

“If phase three trial runs smoothly, it will be completed before August. Then followed by an evaluation in the next 6 months to one year,” she explained.