Main researcher of the Merah Putih Vaccine clinical trial at Airlangga University, (Unair) Surabaya, Dr. Dominicus Husada, SpA(K) confirmed that the vaccine development process will reach phase three of the clinical trial in June 2022.
“Clinical trials will run according to plan. Currently, we are preparing for phase 3,” Husada remarked while contacted by ANTARA on Friday.
Husada’s side is preparing several aspects related to the clinical trial, including participants receiving vaccine injections, vaccines, researchers, budget, and the readiness of the hospitals responsible for the jabs.
Phase three clinical trials will study immunity to the virus that causes COVID-19 from a larger number of participants than the phase two. An estimated 3,500 participants will be involved in the phase 3 clinical trials and will be monitored for 6-12 months.
Husada said that his side had not collected 3,500 participants yet, so efforts were being made to reach that figure.
Meanwhile, the results of the phase 2 clinical trial studied the two aspects of safety and benefits. In terms of safety, the Merah Putih vaccine is proven safe, which has been proven throughout clinical trials.
Meanwhile, from the benefits aspect, Husada said that phase 2 clinical trials showed that immunity was created as expected in the vaccine recipients.
The Unair Merah Putih Vaccine was developed in collaboration with PT Biotis Pharmaceuticals Indonesia and the Regional General Hospital (RSUD) Dr Soetomo in Surabaya, East Java.
Phase 1 clinical trials of the attenuated or killed virus-based COVID-19 vaccine had begun since February 9, 2022, by injecting the vaccine to 90 people at the Dr Soetomo Hospital.
PT Biotis will be responsible for the parallel production of the Merah Putih Vaccine during the Phase 3 clinical trials by increasing the scale of production, including of commercialized vaccines.
If the entire second and third phase of the clinical trial proceeds well, the Merah Putih Vaccine will obtain Emergency Use Authorization (EUA) and be ready to be distributed to the public.
Source: Antara News