Jakarta (Indonesia Window) – Indonesia’s COVID-19 vaccine named Merah Putih made by Airlangga University researchers is targeted to have Emergency Use Authorization (EUA) in the first half of 2022, said Head of the National Agency of Drug and Food Control Penny K Lukito.
The statement was made at a virtual press conference on handing over the certification of Good Manufacturing Practices to Biotis Pharmaceutical Indonesia, Wednesday (Aug. 18).
Merah Putih vaccine is produced by Biotis Pharmaceutical Indonesia and Airlangga University.
Penny said the researchers had completed the first phase of transgenic preclinical trials and are now entering the second phase of preclinical trials on macaque.
Before obtaining EUA, she continued, the vaccine would be tested on humans in the near future.
Penny said the agency together with the pharmaceutical industry, researchers and sponsors continue to provide assistance in the development of the vaccine’s preclinical test.
“The agency continues to discuss some aspects regarding rational research development, preclinical and clinical trial plans and designs, as well as formula and drug quality developments, with the researchers,” she said.
Penny added that all vaccines must be produced on a laboratory scale by following good clinical trial rules.
“These preclinical and clinical tests would become the scientific data that underlie the next registration processes,” she explained.
Reporting by Indonesia Window