After going through a series of long stages from research, formulation, development, and pre-clinical trials to the implementation of phase 1 and 2 clinical trials, now the Red and White Vaccine (VMP), which is a domestic vaccine product produced in collaboration between Universitas Airlangga (UNAIR) and PT Biotis Pharmaceuticals Indonesia, has entered the phase 3 clinical trial stage. This was marked by the Kick Off of the Phase 3 Clinical Trial of the Red and White Vaccine on Monday, June 27, 2022 at the Hall of the Faculty of Medicine, Campus A, Airlangga University, Surabaya.

The Kick Off of Phase 3 Clinical Trial of Red and White Vaccine was attended by the Head of POM Penny K. Lukito, Director General of Pharmaceuticals and Medical Devices represented by Director of Pharmaceutical Production and Distribution Agusdini Banun Saptaningsih, UNAIR Rector represented by Vice Rector for Internationalization, Digitalization and Information Muhammad Miftahussurur, President Director of PT Biotis Pharmaceuticals Indonesia FX Sudirman, Head of Red and White Vaccine Research Team Fedik Abdul Rantam, and Principal Investigator of Red and White Vaccine Clinical Trial Dominicus Husada.

The phase 3 clinical trial is planned to involve 4,005 subjects in collaboration with 5 hospitals, namely RSUD dr. Soetomo Surabaya, UNAIR Surabaya Hospital, RSUD dr. Saiful Anwar Malang, Paru Jember Hospital, and RSUD dr. Soebandi Jember to ensure efficacy and monitor adverse reactions from VMP, before it will be used en masse. In addition to primary vaccination, VMP is also encouraged to be used as booster vaccination and vaccination for children. Then to increase access to VMP at the global level, VMP is also encouraged to be registered and get a WHO emergency use listing recommendation. This is a big step in Indonesia's efforts to realize independence in the field of vaccine production, especially the COVID-19 vaccine.

The government supports the use of VMP to increase the use of medicinal products and medicinal raw materials that can be produced locally. This is in line with Presidential Instruction Number 2 of 2022 concerning the Acceleration of Increasing the Use of Domestic Products and Products of Micro, Small and Cooperative Enterprises in order to succeed the National Movement of Proud to be Made in Indonesia, the government reaffirms support and partiality for the use of domestic products including VMP by UNAIR and Biotis.

In her remarks, the Head of the POM Agency expressed his hope that the implementation of this phase 3 clinical trial can run smoothly and the results can be received immediately so that the next process can be carried out and VMP will not only be an alternative choice for the COVID-19 vaccine in Indonesia, but also can become an export product in the future.

Director of Pharmaceutical Production and Distribution added in his remarks, Kick Off Phase 3 Clinical Trial of the Red and White Vaccine is a form of readiness of research and manufacturing infrastructure and domestic human resources for vaccine production from downstream to upstream. “We hope that the cooperation between industry, academics/research institutions, and the government as in this moment will increase the resilience of the pharmaceutical sector in Indonesia.” Agusdini said.

The series of Kick Off events for Phase 3 Clinical Trials of the Red and White Vaccine were continued with a press conference and a review of the readiness of phase 3 clinical trials at RSUD dr. Soetomo and UNAIR Hospital by the Head of BPOM and his entourage and also the Head of the Center for Research and Development of Health Resources and Services Pretty Multihartina.