Red And White Vaccine In First Injection Stage Of Phase 3 Clinical Trial

Head of BPOM Penny Kusumastuti (third right) accompanied by President Director of PT Biotis Pharmaceutical Indonesia FX Sudirman (left), Vice Rector for IDI UNAIR, Head of the Red and White Vaccine Research Team Fedik Abdul Rantam (second right)/ANTARA

JAKARTA - The Main Researcher of the Red and White Vaccine Universitas Airlangga Dominicus Husada said the clinical trial process of the Merah Putih vaccine is still ongoing and is now in the first injection stage of phase 3 clinical trials.

Dominicus said the phase 3 clinical trial itself would be completed six months after the second injection process, which has not yet been implemented.

"Six months after the second injection. Now it's still the first injection," said Dominicus as quoted by ANTARA, Monday, July 11.

"Now we are still collecting samples, still in the process," added the chairman of the Red and White Vaccine Clinical Test Team.

The start of the phase 3 clinical trial of the Red and White Vaccine itself was marked by a kick off event which was held in the Hall of the Faculty of Medicine, Universitas Airlangga, Surabaya, East Java on 27 June 2022.

In the clinical trial phase 3 of the vaccine, the collaboration between Airlangga University and PT Biotis Pharmaceuticals Indonesia, it is planned to involve 4,005 subjects. The clinical trial itself was carried out to ensure the efficacy and monitor the reaction of the Red and White Vaccine.

The phase 3 clinical trial was carried out in collaboration with five hospitals, namely RSUD dr. Soetomo Surabaya, UNAIR Surabaya Hospital, dr. Saiful Anwar Malang, Jember Lung Hospital, and dr. Soebandi Jember.

In addition to being used in primary vaccination, the Merah Putih vaccine is also encouraged to be used as a booster or booster vaccine and vaccine for children.

The COVID-19 vaccine is targeted to be produced this year, after obtaining an emergency use permit from the Food and Drug Supervisory Agency (BPOM).