Good News From Bio Farma! Phase 3 Clinical Trials Almost Completed To Apply For Halal Certification, Indonesian COVID-19 Vaccine Coming Soon On August 17

Illustration. (Photo: Doc. Antara)

JAKARTA - PT Bio Farma (Persero) revealed that the phase 3 clinical trial of the BUMN COVID-19 vaccine is almost complete. Bio Farma has also registered the results of phase 3 clinical trials to obtain an Emergency Use Authorization (EUA) from the Food and Drug Supervisory Agency (POM) Agency.

Director of Bio Farma Honesti Basyir said that currently, Bio Farma has registered the results of the phase 3 clinical trial. In parallel with this, Bio Farma has also completed an audit of the COVID-19 vaccine by LPPOM MUI and will soon be certified for its halal aspect.

"The President has prepared a special name for the BUMN COVID-19 Vaccine and Bio Farma is in the process of registering the name with the Directorate General of Intellectual Property Rights of the Ministry of Law and Human Rights, hopefully on August 17, 2022 Indonesia will have a vaccine made in Indonesia, an offering for Indonesia to break the chain of COVID-19,” said Honesti, in an official statement, quoted on Tuesday, August 2.

Meanwhile, the Medical Advisor of the BUMN COVID-19 Vaccine Clinical Test Team, Soedjatmiko explained that according to the WHO and BPOM vaccine clinical trial standards, all new vaccines must go through 3 stages of clinical trials.

"This clinical trial aims to prove that the COVID-19 vaccine made by Bio Farma is safe and can increase antibody levels significantly to fight the COVID virus, so that it is expected to be efficacious in protecting subjects from serious illness and death due to COVID according to the standards of the POM Agency," said Sudjatmiko.

He said the most commonly reported post-immunization Adverse Events (AEFI) were local pain around the injection area and muscle pain with mild intensity, post-injection fever which would disappear by itself within the next 1 to 2 days.

Phase 3 clinical trials were carried out in four Study Centers, namely the Faculty of Medicine (FK) University of Indonesia, Jakarta, FK Diponegoro University Semarang, FK Andalas University Padang, and FK Hasanuddin University Makassar with a total of 4.050 volunteer subjects nationally.

In an emergency situation like today, research on all COVID-19 vaccines can be accelerated, while still paying attention to the safety, efficacy, or efficacy, and quality standards issued by the POM and meeting the high standards of WHO such as other COVID-19 vaccines currently available. already used in the COVID vaccination program in Indonesia.

"With the COVID vaccine produced by Bio Farma, Indonesia will not need to import from other countries," he said.

For your information, the clinical trial of the SOE (BUMN) COVID-19 vaccine is still running and is optimistic that it will be completed on schedule. The BUMN COVID-19 vaccine is the result of a collaboration between the Pharmaceutical BUMN, Bio Farma, and Baylor College of Medicine, USA, which has been registered in the WHO COVID-19 vaccine candidate development stage since June 2021.