Jakarta, MINA – Head of the Food and Drug Supervisory Agency (BPOM), Penny K Lukito said the InaVac vaccine or Merah Putih vaccine will immediately obtain an Emergency Use Authorization (EUA) in early October 2022. The vaccine is made in Indonesia.
“I think clinical trials have completed and only need analysis. Hopefully the InaVac vaccine will obtain EUA in early October,” said Penny K Lukito at the BPOM RI Building, Jakarta on Friday.
EUA is the first access to get the Covid-19 vaccine. In accordance with EUA requirements, BPOM needs to evaluate aspects of the efficacy, safety, and quality of the InaVac Vaccine in accordance with international Covid-19 vaccine evaluation standards, as well as evaluate the fulfillment of Good Manufacturing Practices (GMP).
“The InaVac vaccine is in its final stages, the data is in, it just needs analysis and waiting for some other data,” said Penny.
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PT Biotis Pharmaceutical Indonesia, which produces the vaccine, in collaboration with researchers from Universitas Airlangga carried out an inactivated virus platform.
The company produces its vaccine in the Gunung Sindur area, Bogor, West Java with a downstream production capacity of up to 20 million doses per month.
For the early stages, its production capacity will be increased to five million doses per month.
“Currently, the quality aspect of the vaccine is being analyzed based on production, of course, the production facilities as well. Then the second is the aspect of the clinical trial results,” said Penny.
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Penny hopes that the EUA for the InaVac Vaccine can be obtained on time. The production of the InaVac vaccine adds product variants made by Indonesia. (T/RI/RE1)
Mi’raj News Agency (MINA)
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