BPOM Issues Approval For Phase 2 Red And White Vaccine Clinical Trials

Head of BPOM RI Penny K Lukito (left) during an inspection of PT Biotis Pharmaceutical Indonesia at Gunung Sindur, Bogor Regency, West Java, Friday (8/4/2022). (ANTARA/Andi Firdaus).

JAKARTA - The Indonesian Food and Drug Supervisory Agency (BPOM) has issued an Approval for the Implementation of Clinical Trials (PPUK) phase 2 for the Red and White Vaccine developed by Airlangga University researchers with PT Biotis Pharmaceutical.

"The BPOM team today carried out inspections and had discussions to review the progress made by PT Biotis as the holder of the Emergency Use Authorization (EUA) which has now reached phase two," said Head of BPOM RI Penny K Lukito in the inspection agenda to PT Biotis. Pharmaceutical Indonesia in Gunung Sindur, Bogor Regency, West Java, reported by Antara, Friday, April 8 afternoon.

Penny said the phase 2 clinical trial started from the initial development of vaccine raw material development (upstream), vaccine formulation (downstream), to the process of filling into vials into finished products.

Inspections are carried out by various officials related to BPOM in a comprehensive manner to ensure that manufacturers consistently apply Good Manufacturing Practices (GMP) standards throughout the vaccine manufacturing process.

Penny said that so far there have been 13 COVID-19 vaccines approved by BPOM that obtained Emergency Use Authorization (EUA) and some have been used in national vaccination programs, but these vaccines are imported vaccines developed from abroad.

This condition encourages the Indonesian nation to be independent in handling the pandemic, one of which is through research and development of domestic vaccines which are the work of the nation's children.

"Today, we convey good news, a progress of ours together that BPOM has given the first PPUK for the vaccine made by the nation's children, namely the Red and White Vaccine," he said.

The Merah Putih vaccine with the Inactivated virus platform was developed using the SARS-CoV-2 virus originating from a COVID-19 patient in Surabaya.

Penny said BPOM as the drug and food supervisory authority in Indonesia has the authority to issue PPUK approvals in Indonesia as approval for the implementation of research activities by involving human subjects.

The research is accompanied by an intervention using the test product, to find or ensure the safety, effectiveness of the test vaccine under study.

The Red and White Vaccine, said Penny, had previously completed data on the results of non-clinical studies in the form of safety and immunogenicity in test animals. BPOM has evaluated data on the safety and immunogenicity of the vaccine in mice and Macaca fascicularis (long-tailed monkeys).

The results of the study showed that the vaccine was safe and well tolerated, there were no deaths and organ abnormalities in the test animals. Furthermore, in the aspect of immunogenicity, there is an immune response that shows the formation of antibodies after vaccine administration.

Since the beginning, BPOM has provided assistance to the development of the Red and White Vaccine starting from the development of vaccine seeds, developing laboratory-scale vaccines for non-clinical testing on test animals, preparing production facilities for scaling up from a laboratory scale including upstream and downstream processes, formulations, and fill and finish.

BPOM also provides assistance in the preparation of clinical trial protocols with an adaptive trial design as an effort to accelerate the implementation of clinical trials so that the vaccine can be immediately accessed by the public after receiving the EUA.

"The vaccine that will be given in this clinical trial has good quality because this vaccine is produced in production facilities that have met the GMP requirements at PT Biotis Pharmaceuticals Indonesia," he said.

BPOM has given a CPOB certificate for the production facilities of the Red and White Vaccine for PT Biotis Pharmaceuticals Indonesia in August 2021, followed by direct inspections to the production site.

Phase 2 clinical trials will include 405 human subjects who will be divided into three groups, namely a group that will receive vaccines at 3 mcg and 5 mcg doses and a control vaccine which will be given two injections at an interval of 28 days.

Phase 3 clinical trials to determine the type of target age group are scheduled to start on May 28, 2022. It is targeted that the Red and White Vaccine will obtain an Emergency Use Authorization (EUA) from BPOM RI in August 2022.