JAKARTADAILY.ID - PT Bio Farma, the state-owned holding company for some Indonesian pharmaceutical companies, is likely to secure the Emergency Use Authorization (EUA) permit for its Covid-19 primary series vaccine in mid-September 2022.
Penny K. Lukito, the head of the Indonesian Food and Drug Authority (BPOM), during a recent hearing with Commission IX at the Indonesian House of Representatives, said that regulators are expecting to release the EUA for IndoVac’s primary series vaccines in mid-September 2022.
"Hopefully in mid-September. They are on the final stages," Penny said at the end of August.
The company said in a statement on Wednesday, September 7, 2022, that it has completed phase 1 and phase 2 clinical trials for its Covid-19 primary series vaccines, or Covid-19 vaccines for people of age 18 and above.
The holding company said it is now proceeding with the Phase 3 clinical trials before it can secure the the EUA from BPOM.
The EUA is a permit to expedite the availability of medical products, including drugs and vaccines from a regulator in a country, during a public health emergency, which include pandemics or disease outbreaks.
As part of the process to secure the Halal certification, the company said its Covid-19 primary series vaccines have passed an audit from The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product.
Meanwhile, the certificate from the Halal Certification Agency (BPJPH) under the Religious Affairs Ministry, is expected to be released in near-term, the company said.
IndoVac needs to secure the EUA first from BPOM before it can secure Halal certification from BPJPH.