COVID-19 – Indonesia issues EUA for Indovac vaccine, AWcorna vaccine

Indovac and AWcorna vaccines have received Emergency Use Authorization (EUA) for the prevention of COVID-19 caused by SARS CoV-2 for individuals aged 18 years and over.

 

Jakarta (Indonesia Window) – Indonesia’s National Agency of Drug and Food Control (BPOM) issued an Emergency Use Authorization (EUA) for Indovac vaccine (domestic production of COVID-19 vaccine), and the AWcorna vaccine on Sept. 24, 2022.

“With the approval of the EUA for these two vaccines, there will be more alternative vaccines that can be used in the COVID-19 vaccination program for adults aged 18 years and over,” BPOM Head Penny K Lukito said when giving a press statement here on Friday.

In addition to the Indovac vaccine, the AWcorna vaccine will be an opportunity for Indonesia to produce its own mRNA (messenger ribonucleic acid) vaccine through a technology transfer process that is currently running, and this can support the country’s ideals of self-reliance for the domestic COVID-19 vaccine, the BPOM head explained.

“The two vaccines have also received a halal fatwa (Islamic legal ruling on permits) from the Indonesian Ulema Council (MUI) and halal certification from the Halal Product Guarantee Agency (BPJPH),” Penny added.

BPOM appreciated the Expert Team of the National Committee for Assessing the COVID-19 Vaccine, and ITAGI (Indonesian Technical Advisory Group on Immunization) for their cooperation in enabling these vaccines to be immediately released to the public.

“The agency also appreciated relevant cross-sectors for having provided supports in the development of domestic vaccines,” she said.

The Indovac vaccine is a COVID-19 vaccine with a recombinant protein subunit platform developed by PT Bio Farma (the Indonesian state-owned vaccine manufacturer), in collaboration with Baylor College of Medicine, USA. This vaccine is the first COVID-19 vaccine to be produced locally in Indonesia from upstream to downstream.

In accordance with EUA requirements, BPOM has previously evaluated the aspects of the efficacy, safety, and quality of the Indovac vaccine by referring to the internationally applicable COVID-19 vaccine evaluation standards, as well as evaluating the fulfillment of Good Manufacturing Practices (GMP).

Taking into account the aspects of safety, efficacy, quality, and compliance with GMP, BPOM has approved the issuance of the Indovac Vaccine EUA with indications as active immunization for the prevention of COVID-19 caused by SARS CoV-2 in individuals aged 18 years and over.

The Indovac vaccine will be used in the primary vaccination given in two injection doses (25 micrograms/dose) at an interval of 28 days. The Indovac vaccine efficacy refers to the results of the immuno bridging test in phase 3 clinical trials, which showed non-inferior vaccine neutralizing antibodies with the comparison protein subunit vaccine (92.5 percent vs. 87.09 percent).

The side effects in the Indovac vaccine clinical trial were reported to be generally mild. The most frequently reported side effects were local pain and muscle aches (myalgia), which were comparable to the side effects of the recombinant protein subunit comparison vaccine that had previously received EUA.

Meanwhile, the AWcorna vaccine was registered by PT Etana Biotechnologies Indonesia (PT Etana) and developed by Abogen-Yuxi Walvax, China.

Taking into account the aspects of safety, efficacy, quality, and compliance with GMP principles, the AWcorna vaccine was approved to obtain the EUA for the indication of preventing infection with the SARS CoV-2 virus in individuals aged 18 years and over.

The dosage of the AWcorna vaccine is given in two injection doses at an interval of 28 days. As a heterologous booster vaccination, it is given in a single dose of 15 micrograms/dose after six months of the second dose of primary vaccination using an inactivated vaccine (Sinovac or Sinopharm).

From the results of clinical trials, the efficacy of the AWcorna vaccine against the wild type (unmutated COVID-19 virus) was 83.58 percent, while the AWcorna vaccine’s efficacy against the Omicron variant was 71.17 percent in preventing moderate cases of COVID-19.

The safety of the AWcorna vaccine is generally well tolerated and the reported side effects are mild. The most commonly reported side effects are fever, pain at the injection site, fatigue, muscle aches (myalgia), headache, chills, swelling, and itching (pruritus).

Reporting by Indonesia Window