Domestic COVID-19 Vaccine Completing The Final Phase Of Clinical Trials

JAKARTA - The domestically produced COVID-19 vaccine developed by PT Bio Farma together with Baylor College Medicine will soon complete the final phase of clinical trials.

"In a matter of days, Bio Farma as a vaccine maker will submit the results of phase 3 clinical trials to BPOM, after it is confirmed that they have gone through clinical trial stages 1 and 2," said Advisor to the BUMN COVID-19 Vaccine Clinical Test Team, Soedjatmiko, as quoted by ANTARA, Thursday, 4 August.

He said that standard clinical trials of vaccines were carried out in accordance with the provisions of the World Health Organization (WHO) and the Food and Drug Administration (BPOM), namely through three stages of clinical trials to obtain an Emergency Use Authorization (EUA).

Phase 1 clinical trials started on February 16, 2022 have good results. The clinical trial involved a total of 175 human subjects ranging in age from 18 years to evaluate the safety and preliminary immunogenicity of the vaccine.

The requirements for the subjects in the study included that they had never received doses of vaccines 1 and 2, and had never been exposed to COVID-19.

"In phase 1 clinical trials, we need to prove that this vaccine candidate is safe to give to the public and to see to what extent this vaccine candidate can produce the expected antibodies," he said.

In April 2022, BPOM issued an Approval for the Implementation of Clinical Trials (PPUK) phase 2 which involved around 360 subjects to be observed for six months.

Soedjatmiko said the clinical trial aims to prove that the COVID-19 vaccine made by Bio Farma is safe and can increase antibody levels to fight COVID-19, so that it can protect the public from serious illness and even death.

The conclusion of the provisional evaluation, said Soedjatmiko, was the result of the IgG antibody titer test and neutralization, there was a significant increase in antibody titer up to 28 days after the second vaccination.

Then, in terms of safety evaluation, the incidence of adverse events up to 28 days after the second dose did not generally differ between groups.

The most commonly reported events were local pain around the injection site and muscle pain with mild intensity, none with severe intensity.

"The results of routine blood tests and biochemistry showed values were within normal limits and there was no significant deviation up to seven days after the first dose," he said.

Head of Surveillance and Clinical Trials Division, Rini Mulia Sari, said that clinical trials of vaccines are not new to Bio Farma. "Because we have carried out clinical trials more than a dozen times, one of which was during the phase 3 clinical trial of the COVID-19 vaccine which was carried out in Indonesia," he said.

Previously, SOE Minister Erick Thohir said that the state-owned vaccine for the Corona virus was now almost completed and was being carried out by the UAE BPOM before being launched to the public.

"We are waiting for the Emergency Use Authorization which will be given in a week or two, I'm still waiting," he said in an interview on the sidelines of the Joint Recruitment Inauguration at the Tennis Indoor Stadium Senayan, Jakarta.