In Front Of Commission IX Of The House Of Representatives, BPOM Conveys The Readiness Of Two Domestic Vaccine Production Facilities

JAKARTA - The Head of the Indonesian Food and Drug Supervisory Agency (BPOM) Penny K Lukito reported the readiness to produce two domestic COVID-19 vaccine candidates in the midst of the clinical trial phase which is still rolling in 2022.

"We are providing assistance and acceleration to ensure the independence of domestic vaccines and drugs during the COVID-19 pandemic. Currently there are two being assisted regarding domestically produced vaccines," said Penny K Lukito during a Hearing Meeting (RDP) which was attended from YouTube. Commission IX of the Indonesian House of Representatives in Jakarta, reported by Antara, Tuesday, January 18.

The first thing is the Red and White Vaccine which is being researched by Universitas Airlangga (Unair) together with PT Biotis which will be mass developed. Currently the process has completed preclinical animal trials and is awaiting implementation of the phase one clinical trial protocol in early February 2022.

"It is estimated that on February 5, 2022, the phase 1 clinical trial of the Red and White Vaccine will be launched," he said.

Second, is the COVID-19 vaccine developed by PT Bio Farma in collaboration with Baylor College of Medicine USA. "Phase 1 clinical trials are expected to take place around February 2022," he said.

Penny said BPOM continues to provide support for the readiness of production facilities for the Red and White Vaccine and vaccines produced by PT Bio Farma and PT Biotis.

"PT Bio Farma and the Eijkman Biomolecular Institute are developing a Red and White Vaccine with a subunit protein recombinant platform. Currently the same production facility is being prepared for the production of the Baylor BUMN vaccine which is in phase 1 clinical trials and clinical trials 1 and 2 are being prepared for the Red and White Vaccine. ," he said.

Meanwhile, PT Biotis, said Penny, had obtained a Good Manufacturing Practices (CPOB) certificate in August 2021 for the provision of facilities for the manufacture of raw materials to finished products.

"Currently in the process and an approval letter has been issued for the use of facilities for the Red and White Vaccine clinical trial product and is in the process of clinical trials for phases 1 and 2. It is estimated that starting February 2022," he said.

In this activity, Penny also reported on the development of the Zifivac vaccine developed by PT Jakarta Biopharmaceutical (JBio) and the mRNA platform vaccine product developed by PT Etana. "This vaccine product is in collaboration with other countries," he said.

PT JBio's production facility, said Penny, is in the process of being developed since November 2020. Currently, it is in the construction stage with a production target of August 2022.

"In parallel, it will start with fill and finish products at PT Biotis from Zifivac products while waiting for JBio to finish construction," he said.

Meanwhile, PT Etana plans to produce a COVID-19 vaccine with an mRNA platform starting in March 2022 after all of its production facilities have received a GMP certificate on December 30, 2019. "PT Etana is the fourth pharmaceutical industry facility that can produce COVID-19 vaccine domestically," he said.