Protocols for the clinical trial of the Merah Putih vaccine, developed by Airlangga University (Unair), have entered their final stage, head of the National Agency of Drug and Food Control (BPOM), Penny K Lukito, has informed.

“BPOM has assisted the pre-clinical test and the vaccine will soon enter clinical trials,” she said during a focus group discussion on the ‘Independence of Raw Materials for Medicine, Medicine, and Biological Products’ on Tuesday.

The strategy implemented by BPOM for supporting the indigenous development of domestic vaccines involved seeking assistance from many parties, including PT Biotis Pharmaceutical Indonesia, which will work with Unair in testing its vaccine on human subjects, Lukito added.

The protocol for the clinical trial of the Merah Putih vaccine must run according to the provisions, while ensuring the authenticity and validity of data so that the vaccine can be registered and cleared by BPOM for use.

Lukito said that BPOM has also been tasked with supporting the production facilities of the pharmaceutical industry. The goal is to have production facilities that meet the Good Laboratory Practices (GLP) standard or good drug production methods, she explained.

“This is to ensure that the production guarantees the quality, safety, and efficacy aspects (recorded) during research and clinical trials,” she said.

The COVID-19 pandemic has pushed BPOM to use various strategies to accelerate innovation and regulate clinical trials in the country, Lukito said.

“What should have taken several years has been shortened while still prioritizing the aspects of quality, safety, and efficacy of pharmaceutical products,” she noted.

BPOM has also intensified communication with the World Health Organization (WHO) and foreign drug regulators so that domestically produced vaccines can fulfill international standards in terms of quality and efficacy, she added.

Source: Antara News