BPOM Denies Children Step On Nusantara Vaccine, Many 'Red' Notes That Need To Be Improved By Research Team

JAKARTA - The Food and Drug Administration (BPOM) stated that it is not compassionate regarding clinical trials of any vaccine including nusantara vaccine. BPOM will support various research efforts in vaccine development.

Thus the statement of head of BPOM Penny Kusumastuti Lukito in the Workshop on Red and White Vaccine Control, Jakarta, reported from Antara, Tuesday, April 13.

"BPOM will never be compassionate. BPOM will support any form of research when it is ready to enter the clinical trials will be accompanied still but certainly with the enforcement of various standards that already exist."

Nusantara vaccine has not been able to proceed to the advanced clinical trial stage because some conditions have not been met. Among them, How to Test a Good Clinical Practical( Good Clinical Practical), Proof of Concept, Good Laboratory Practice and How to Make Good Medicine (Good Manufacturing Practice).

Penny said, it supports various vaccine development as long as it meets scientific rules to ensure vaccines are safe, efficacious, and quality.

Intensive mentoring starts from before the clinical trial, issued a Clinical Trial Implementation Approval (PPUK), and there are commitments that must be fulfilled already done BPOM. Including, continued Penny, inspection related to Vaksin Nusantara.

According to Penny, if there is a clinical trial that does not meet the standards or scientific stages, it will experience problems and can not proceed to the following process.

"These stages cannot be ignored, and the neglect is very much an aspect in the implementation of clinical trials of phase 1 of the dendritic vaccine. And it has been conveyed to the research team of course for the commitment of corrective action, preventive action that should have been given from the beginning but always ignored still can not be later back to back," he said.

He said the proof of concept of nusantara vaccine has also not been fulfilled. The antigens used in the vaccine also do not meet pharmaceutical grade.

The results of phase 1 clinical trials related to the safety, effectiveness or potential ability of immunogenability to increase antibodies are also not convincing so it is not yet able to step up for the next phase.

Penny said it did not stop the Nusantara vaccine. The research team needs to make improvements and deliver improvements to BPOM as the results of the review provided by BPOM to the nusantara vaccine research team.

"Please correct the proof of concept, then the data needed to prove the validity of the stage 1 clinical trial, then if it is all fulfilled then we decide whether it is possible to step into the next phase," he said.

Until now, BPOM has not issued a license for the Approval of Clinical Trial Implementation (PPUK) of phase II clinical trials for nusantara vaccine. BPOM will continue to assist if there is a desire from the research team to improve.

BPOM wants to ensure that the quality of the vaccine is indeed feasible to be used as a product in clinical trials using humans.

"There is a corrective action (improvement) that they have to give until now until the time given we have not received," said Penny