BPOM issues clinical trial permit for domestic Merah Putih vaccine

Jakarta (ANTARA) - The National Agency of Drug and Food Control (BPOM) has issued the Clinical Trial Protocol Permit (PPUK) for the Merah Putih (Red and White) coronavirus vaccine manufactured domestically by Airlangga University and a private pharmaceutical company.

At an online press conference on Monday, BPOM's Head Penny K. Lukito noted that the Merah Putih Vaccine, using an inactivated virus platform, was developed by using the SARS-CoV-2 virus from a COVID-19 patient in Surabaya, East Java.

BPOM, as the food and drug control agency in Indonesia, has the authority to issue PPUK in Indonesia.

PPUK is a form of agreement to conduct research that involves human subjects along with utilization intervention pertaining to the tested products.

This aims to find or ensure the clinical, pharmacological, and/or other pharmacodynamical effects, and/or to identify unwanted reactions, and/or to learn absorption, distribution, metabolism, and excretion.

"The goal is to ensure the safety and/or the effectiveness of the tested vaccine," she remarked.

To reach the clinical trial phase, the non-clinical study result data, in the form of safety and immunogenicity of the test animal, is necessary, Lukito noted.

"The BPOM had evaluated data on this vaccine's safety and immunogenicity on mice and Macaca fascicularis (long-tailed monkey) test animals," she remarked.

"The study result indicates that the vaccine is safe and tolerable, and it does not cause death as well as organ abnormality in the tested animals," she affirmed.

In terms of immunogenicity, an immune response indicates antibody formation after the vaccine's administration.

The Merah Putih vaccine is of good quality, as it was produced in a facility and infrastructure that met the applicable standard in PT Biotis Pharmaceuticals Indonesia, she remarked. (*)