TEMPO.CO, Jakarta - Deputy chairman of the House of Representatives (DPR) Health Commission, Emanuel Melkiades Laka Lena, explained reasons for criticizing the Food and Drug Monitoring Agency (BPOM) over the development of the Nusantara vaccine.
“It is found out last night that the BPOM has no legal authority to assess the preclinical trial and even intervene in the process that is academically or scientifically running,” Melki told Tempo on Friday, April 9.
According to Melki, the BPOM should not reject the phase II clinical trial of the Covid-19 vaccine candidate if there are deficiencies in the results of the phase I clinical trial that could be later improved, let alone stopped the research as no fatal events occurred. “The authority demonstrated by BPOM is beyond the given authority based on the regulation,” he added.
The House official opined that BPOM had been too strict towards the vaccine development compared to its granting of the emergency use permit (EUA) for other vaccines that were based on reports delivered by the producer.
As long as having a political will, Melki said the BPOM should be able to help and support the development of the domestic Covid-19 vaccine.
In the recent meeting in the DPR, BPOM head Penny Lukito was bombarded with questions and criticisms from House members regarding the development of the Nusantara vaccine initiated by former health minister Terawan Agus Putranto. Several commission members encouraged Penny to grant permission for the phase II clinical trial of the vaccine.