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
The decision was also based on recommendation issued by the Indonesian Technical Advisory Group on Immunization (ITAGI).
Merah Putih Vaccine Recipients Will Be Monitored for a Year
One of the researchers from Airlangga University Dominicus Husada confirmed that volunteers taking part in Merah Putih vaccine trial will be monitored for a year after they received the shot.
“The next step will be a one-year monitoring,” Husada said on Wednesday, February 23, as reported by Antara.
90 volunteers took part in the phase one trial at Regional Public Hospital (RSUD) Dr. Soetomo in Surabaya, East Java, which started on February 9.
The medical expert explained that researchers will take blood samples from participants prior to and after receiving the Merah Putih vaccine.
According to him, the first phase will assess the vaccine’s safety, and if it shows satisfactory results, the team will go ahead with the second and third phases.
If everything goes according to plan, the third phase is estimated to be completed next year.
The University will submit the result of clinical trials to the Drug and Food Control Agency (BPOM) where the Agency will then issue an emergency use authorization (UEA) upon evaluation on the safety and efficacy aspects of the vaccine.
Merah Putih vaccine is developed by Airlangga University and PT Biotis Pharmaceuticals Indonesia, and previously, head of BPOM Penny Lukito revealed that phase two of the clinical trial will 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 February 7.