BPOM Issues Bio Farma License For COVID-19 Vaccine Production

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JAKARTA - The Food and Drug Supervisory Agency (BPOM) has conducted an inspection on how to manufacture a good drug (CPOB) for the COVID-19 vaccine in the production facilities of PT Bio Farma.

Head of BPOM Penny K. Lukito said, based on the results of the inspection and verification process on the stages of the production process and vaccine quality assurance, his party had issued CPOB to Bio Farma. That way, Bio Farma can produce the COVID-19 vaccine.

"The results of the evaluation and verification show that the production facilities have met the requirements, so the CPOB certificate can be issued today," said Penny in a virtual press conference, Wednesday, December 30.

By issuing a CPOB certificate that ensures the safety, efficacy / efficacy, and quality of the vaccine, the fill and finish product process can be carried out immediately after the bulk of the vaccine arrives.

After holding a CPOB certificate, the next stage for PT. Bio Farma will soon set up a production facility with a capacity of 150 million doses, so that next year it can produce up to a total of 250 million doses per year.

This state-owned pharmaceutical company has a fill and finish production room for COVID-19 vaccines with a production capacity of 100 million doses per year.

Furthermore, Penny said that currently the process of providing emergency use authorization (EUA) for the COVID-19 vaccine from Sinovac had entered the completion stage.

Researchers who conducted vaccine clinical trials in Bandung with PT. Bio Farma is currently analyzing clinical trial data to support the efficacy and safety of vaccines in EUA administration.

"The POM continues to monitor the implementation of clinical trials and evaluate the results of clinical trials to ensure the vaccine to be used is safe and efficacious," said Penny.

Responding to this, the President Director of Bio Farma, Honesti Basyir, welcomed the CPOB vaccine certification. "Thus, Bio Farma deserves to make a vaccine," he said.