The Nusantara Vaccine Proceeds To Phase 2 Clinical Trials Even Though They Can't Get Permission, The Food and Drug Supervisory Agency Put Their Hands Off

Head of POM Penny K. Lukito (BPOM Public Relations Photo via ANTARA)

JAKARTA - The Nusantara vaccine research team made by former Health Minister Terawan Agus Putranto began to continue the phase 2 clinical trial by taking blood samples.

Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito said that if the Nusantara vaccine was determined to continue the stages. This is because her party has not issued a phase 2 permit.

"The results of the BPOM assessment related to phase 1 of the clinical trial of the dendritic or the Nusantara vaccine is that it cannot be continued to phase 2. It is clear. What is currently happening is outside the BPOM, in this case, it is not up to us to judge it", Penny said in a virtual press conference, Friday, April 16.

According to Penny, the Nusantara vaccine still has to make improvements because there is an incompatibility of phase 1 clinical trial process with the rules of good manufacturing practice (GMP) and good clinical practice (GCP).

"Because there are findings of correction action, preventive action, corrections given by the BPOM must be corrected first, if we want to continue to phase 2. We are waiting for the corrections to be made", she said.

Previously, the main research team for the Nusantara vaccine, Colonel Jhonny, said that currently, the Nusantara vaccine has continued the phase 2 clinical trial at the Gatot Soebroto Central Army Hospital (RSPAD), Central Jakarta.

On Wednesday, April 14th, a number of political figures and officials, including members of the Indonesian House of Representatives (DPR RI) joined the phase II clinical trial volunteers. In this stage, the vaccine volunteers will take a blood sample and process it for the next 7 days.

"In phase 2, we will monitor even though we have been vaccinated and in phase 1 we already know that this vaccine is safe, still, in phase 2, the safety for the subject, we will still pay attention and follow up for 60 days", said Jhonny.

In this phase 2 of the clinical trial process, researchers limited that they would only take 180 blood samples. As many as 30 volunteers will take blood samples each day.

Jhonny claims that his party has its own supervisor in developing vaccines other than the BPOM. However, Jhonny was reluctant to reveal which agency oversaw the vaccine made by former Health Minister Terawan Agus Putranto.

"In making this vaccine, we are audited by a third party to see good manufacturing product or good manufacturing practice (GMP), so we are monitored whether we do it according to standards or not", said Jhonny.

"Who is the third party?" asked the reporter.

"One body that monitored the GMP. It is still a secret", he replied.