ヌサンタラワクチン研究チームは、BPOMのほかに独自のスーパーバイザーを持っていると主張しますが、秘密
JAKARTA - The main research team of Nusantara vaccine, Colonel Jhonny claimed that it has its own supervisor in undergoing vaccine development in addition to the Food and Drug Administration (BPOM).
However, Jhonny was reluctant to reveal which institution supervised the vaccine by former Minister of Health Terawan Agus Putranto.
"We, in the manufacture of this vaccine is audited by a third party to see good manufacturing product or good manufacturing practice (GMP), so supervised according to standards or not," said Jhonny at Gatot Subroto Hospital, Central Jakarta, Wednesday, April 14.
"Whose third party?" asked the reporter.
"One body that sees GMP. From whom it is still a secret," he replied.
In addition to third-party supervisors, Jonny also mentioned that there is an independent body which is a Contract Research Organization (CRO) based in Indonesia that provides clinical trial support based on Good Clinical Practice (GCP), namely Prodia.
"Then in the implementation of this clinical trial the research stage is supervised also by an independent body as well, so we are monitored, there is a body, namely CRO clinical Research Organization, CRO is coincidental at this time from Prodia, so we do not make any origins," he said.
Previously, the Head of the Food and Drug Administration (BPOM) Penny K. Lukito explained why it did not give permission for the COVID-19 Nusantara vaccine to conduct phase II clinical trials.
Penny said, the team of vaccine researchers by former Minister of Health Terawan Agus Putranto repeatedly ignored the results of the request and evaluation bpom.
In fact, based on the results of phase I clinical trials by BPOM, Nusantara vaccine is considered to have not met many rules of clinical trial stages, including good manufacturing practice and good clinical practice.
"Commitment correction action or prevention action has been requested from the beginning, but ignored, ignored, ignored. Still can't, back to back. So various aspects, good clinical practice and good manufacturing practice for vaccine production have not been met," said Penny.
Penny admitted that it has not passed the clinical trial phase I of nusantara vaccine, so it has not been able to get approval for phase II. Conceptually, nusantara vaccine is also not valid and the data is still incomplete.