The Indonesian Drug and Food Control Agency (BPOM) said it will penalize two pharmaceutical companies after ethylene glycol (EG) and diethylene glycol (DEG) were detected in their syrups.
The first vaccine is called Indovac for the state-owned enterprises (SOEs) vaccine, and the second one is the red and white vaccine, with an inactivated virus platform called Inavec
Vaccine distribution in the country declined quite sharply.
TheIndonesia.id - After the Drug and Food Control Agency (BPOM) issued approval for clinical trial protocol (PPUK) for locally developed Merah Putih vaccine, 90 volunteers are set to take part in the first phase of its clinical trial.
Head of the Agency Penny Lukito also said phase two of the clinical trial will follow and involve 405 volunteers.
“Phase one and two will involve 90 and 405 subjects, respectively – and [they’re all] human subjects. Subjects will be divided into three groups [which will be administered] with three different doses,” Lukito said on Monday, February 7, as reported by Antara.
All subjects must be at least 18 years of age, and the phase one trial is planned to be carried out on February 9 at Regional Public Hospital (RSUD) Dr. Soetomo in Surabaya, East Java.
Lukito explained that phase three clinical trial will only take place when interim results are announced and phase one and two are deemed to be meeting all necessary requirements.
When interim result of phase three is declared, approval process can begin in BPOM, and emergency use authorization (UEA) for the vaccine might be obtained in mid-July this year.
Merah Putih vaccine is developed by Airlangga University and PT Biotis. Rector Mohammad Nasih said the university is optimistic that early phase trials will show the safety of Merah Putih vaccine. If everything goes according to plan, Nasih expected the third phase trial to start in March.
