Food and Drug Control Agency Issues Bio Farma Emergency Permit For Production Of COVID-19 Vaccine

JAKARTA - The Food and Drug Control Agency (BPOM) issued an emergency use authorization (EUA) to PT Bio Farma to produce a vaccine for COVID-19.

This was said by the Head of the Food and Drug Control Agency Penny K. Lukito during the signing of the emergency permit to PT Bio Farma.

"Emergency use authorization for vaccines produced by PT Biofarma can be approved today. The vaccine produced by PT Biofarma is named 'COVID-19 Vaccine'", said Penny in a virtual press conference, Tuesday, February 16.

In the process of producing the newly permitted vaccine, PT Bio Farma is cooperating with technology transfer from the Chinese vaccine manufacturer Sinovac.

Bio Farma gets raw materials in the form of bulk vaccines from Sinovac. This bulk production process will be processed by Bio Farma. The arrival of the bulk importation of vaccines from Sinovac has been carried out twice, namely 15 million doses on January 12, and 11 million doses on February 2, 2021.

Although the COVID-19 vaccine produced at PT Biofarma has the same content and profile, quality, efficacy, and safety as the CoronaVac vaccine produced by Sinovac, the issuance of emergency permits is still being re-issued.

"This requires special testing and evaluation and provision of separate EUA with the CoronaVac vaccine due to differences in production sites and differences in packaging. So, it needs to be registered again before getting approval for use", said Penny.

This vaccine has a 5 milli vial dosage form. This vaccine contains 10 vaccine doses per vial which are the vaccines of the inactivated virus. Packed in a box containing 10 vials, stably stored at a temperature of 2 to 8 degrees Celsius.

"Each vial is equipped with a two-dimensional barcode, which shows the identity of each vial and functions to track and prevent vaccine counterfeiting", she added.