BPOM Estimated EUA InaVac Vaccine Terbit In Early October 2022

Director of PT Biotis Pharmaceuticals Indonesia FX Sudirman shows the Inavac Vaccine in the quality/via ANTARA examination room

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K Lukito said InaVac's domestically produced vaccine will soon obtain an Emergency Use Authorization (EUA) in early October 2022. "I think it's over (the clinical trial), it's just an analysis. We hope that early October the EUA will issue a Red and White Vaccine, namely the InaVac Vaccine," said Penny K Lukito at a press conference on the launch of the domestic vaccine EUA at the BPOM RI Jakarta Building, Antara, Friday, September 30. EUA is the initial access door to obtain the COVID-19 vaccine that the community needs as a strategic effort to overcome the pandemic and protect against the risk of COVID-19 transmission. According to the EUA requirements, BPOM needs to evaluate the efficacy, safety and quality aspects of the InaVac Vaccine by referring to the international COVID-19 vaccine evaluation standards, as well as evaluating the fulfillment of Good Manufacturing Practices (CPOB). "The red and white vaccine is in the final stages, the data has been entered, we just need to analyze it and wait for some other data," he said. The InaVac vaccine produced by PT Biotis Pharmaceutical Indonesia in collaboration with Universitas Airlangga researchers carried an inactivated virus or virus platform that was weakened. PT Biotis places its production facilities in the Gunung Sindur area, Bogor Regency, West Java with a production capacity of up to 20 million doses per month. However, specifically in the early stages, it will be increased to 5 million doses per month. "Currently, the quality aspect is being analyzed based on production, of course the production facilities are also. Then the second is the aspect of the results of clinical trials," he said. Penny hopes that the EUA for the InaVac Vaccine can be accepted on time so that the presence of the Red and White Vaccine adds to the product variant and becomes a source of pride for Indonesia.