The state-owned enterprises (SOEs) vaccine against COVID-19, developed by state-owned pharmaceutical company PT Bio Farma and Baylor College Medicine, will soon complete the final phase of clinical trials.
"In several days, Bio Farma, as the vaccine producer, will submit the results of Phase 3 of the clinical trials to the National Food and Drug Supervisory Agency (BPOM)," vaccine clinical test advisor for the SOEs COVID-19 vaccine, Soedjatmiko, informed in Jakarta on Thursday.
Standard clinical trials have been carried out for the vaccine in accordance with the provisions of the World Health Organization (WHO) and BPOM, that is, three phases of clinical trials have been conducted for obtaining emergency-use authorization (EUA) for the vaccine.
Soedjatmiko said that Phase 1 of the clinical trials started on February 16, 2022, and showed good results. The trial to evaluate the safety and preliminary immunogenicity of the vaccine involved 175 human participants aged 18 and above.
The participants had never received any other COVID-19 vaccine and had never been exposed to the disease.
"In Phase 1 clinical trials, we needed to prove that the vaccine is safe for the public and to test the efficacy," he said.
In April 2022, BPOM approved Phase 2 of the clinical trial (PPUK), which involved around 360 participants and lasted six months.
The clinical trial aimed to prove that the vaccine was safe, increased antibody levels against COVID-19, and protected recipients from severe symptoms and mortality.
The result from the temporary evaluation showed that there was a significant increase in antibody titer in participants up to 28 days after the second vaccination.
In terms of safety, the incidence of adverse events following immunization (KIPI) up to 28 days after the second dose did not generally differ between groups.
The most common side effects reported were localized pain around the injection site and muscle pain, none of severe intensity.
"The results of routine blood tests and biochemistry showed the values were within normal limits, and there was no significant deviation up to seven days after the first dose," Soedjatmiko disclosed.
Meanwhile, head of surveillance and clinical trials division, Rini Mulia Sari, said that Bio Farma has conducted clinical trials for other vaccines before the COVID-19 vaccine.
"We have carried out clinical trials more than a dozen times, one of which was the Phase 3 clinical trial of the COVID-19 vaccine, which was carried out in Indonesia," Sari informed. (Antaranews)