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.
Also read: Bio Farma Plans to Produce 20 million Doses of 'IndoVac' Covid-19 Primary Series Vaccines This Year
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.
Bio Farma said in the same statement it also has processed the Halal (or Shariah compliant) permits for the IndoVac’s primary series vaccines to provide comforts to the Indonesian Muslim consumers.
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.
Also read: Bio Farma Says Clinical Trials Underway for its 'IndoVac' Covid-19 Booster Vaccines
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.
Bio Farma is currently manufacturing three types of Covid-19 vaccines, the primary series, the Covid-19 booster vaccines and Covid-19 vaccines for children.