The EUA For Red And White Vaccine Expected To Be Out In September
JAKARTA - Head of Food and Drugs Supervisory Agency (BPOM) Penny K. Lukito said the process of developing the Red and White Vaccine will enter the third phase of clinical trials. Emergency use authorization (EUA) is expected to be issued in September 2022.
In a hearing with the House of Representatives (DPR RI) Commission IX Committee on supervision of the COVID-19 vaccine in Jakarta, Tuesday 31, Head of the BPOM Penny said the Red and White Vaccine collaboration between Unair and PT Biotis is currently in the finalization of the second phase of clinical trials and is expected to enter the third phase this second week of June.
"The estimate is that we wait, hopefully around August we can complete the third phase and emergency use authorization can be completed in September," said Penny as quoted by Antara.
The vaccine with the inactivated virus platform using a different method is entering the third phase of clinical trials so that it can be accelerated while ensuring that the immunogenicity aspect is maintained.
The Merah Putih vaccine has obtained a halal certificate together with Sinovac, Bio Farma's COVID-19 vaccine, and Zifivax.
"It has been certified halal for the Red and White Vaccine," he said.
Meanwhile, the clinical trial stages of the vaccines developed by PT Bio Farma and Baylor College Medicine are still in the same period.
"Based on the stages that we monitor, it is still in the same period," said Penny.
SEE ALSO:
On this occasion, the Director General of Pharmaceuticals and Medical Devices of the Ministry of Health (Kemenkes) Lucia Rizka Andalusia said that in the third or fourth semesters, the procurement of vaccines could use domestic production.
"The stage of vaccine production is expected to be available in July or August, so it is estimated that in the third or fourth semester of vaccine procurement, domestically produced vaccines will be used," said Rizka.