TEMPO.CO, Jakarta - Food and Drug Monitoring Agency (BPOM) Head Penny Lukito said the agency’s assessment of the Nusantara Vaccine had complied with the applicable standards.
“There are also stages in the implementation of clinical trials. All stages cannot be skipped. If they are skipped and ignored, they will have to be done again from the start. So they cannot move forward,” said Penny in a press conference on Friday, April 16, 2021.
Penny said vaccine development was a form of advanced technology product that had full standards to be met. Researchers must follow Good Laboratory Practice (GLP) up to Good Manufacturing Practice (GMP) during the manufacturing process.
Reports revealed irregularities in the Nusantara vaccine developed by former Health Minister Terawan Agus Putranto. Two days ago, the research team decided to proceed with its second clinical trial sans an approval of BPOM. The research team collaborated with a number of lawmakers of the House of Representatives (DPR) and national figures who become volunteers for the clinical trial.
Penny was non-committal about the issue. “What is happening now is not under BPOM’s authority. We do not assess it,” Penny confirmed.
She also emphasized that BPOM would continue to provide assistance during clinical trials in accordance with the internationally-accepted standards of Good Clinical Trial. “There are no exceptions for all vaccine development in Indonesia. No exceptions. All [vaccine development is assessed] the same,” said Penny Lukito.