TEMPO.CO, Jakarta - Chief of the Covid-19 vaccine clinical research team from the University of Padjadjaran, Kusnandi Rusmil, said that the safety aspect of the potential vaccine developed by China’s pharmaceutical firm Sinovac has been checked many times. The vaccine candidate is in the third-phase clinical trial in Bandung.
“It passes the third clinical trial. The vaccine can be used, followed by post-marketing surveillance. So vaccines that are permitted to be used have undergone safety controls many times,” said Kusnandi as quoted from Antara on Wednesday, October 28, 2020.
He explained that there are many stages of clinical trials, namely preclinical and clinical trials. Preclinical studies include stringent preclinical animal and in vitro studies. “If it is safe, the next stage is human trials that have four stages in order to observe the safety, immunogenicity, and the drug efficacy,” Kusnandi added.
State-owned pharmaceutical firm Bio Farma R&D manager Neni Nurainy said the team would keep monitoring the side effects and events following the immunization of the vaccine candidate.
“There is no perfect drug, it must have side effects. In the clinical trials, we are monitoring events following the immunization,” said Neni last Monday.
She reiterated that volunteers were obliged to write down any events after injection in the given form. The data would be collected and analyzed. “We monitor the local reaction and the system in 48 hours after the vaccination and still monitor it for the next six months,” Neni said.
Based on the research of the first phase, the second phase, and several reports from the third phase, common symptoms appeared after the injection of Sinovac’s potential Covid-19 vaccine included pain at the injection site. A few people also experienced fever and headache.