TEMPO.CO, Jakarta - Epidemiologist from Airlangga University (Unair), Windhu Purnomo, said the research team of the Nusantara vaccine should have accepted the decision of the Food and Drug Monitoring Agency (BPOM) to not grant a permit for the phase-2 clinical trial. Windhu said it was the agency's job to control medicinal products, including vaccines, in order to protect the public.
“That's its job. So BPOM cannot be intervened,” said Windhu to Tempo on Sunday, April 18, 2021.
Windhu assessed that BPOM has shown good independence and credibility. He recalled the agency’s stand when Unair developed a combination drug for Covid-19 in collaboration with the State Intelligence Agency (BIN) and the Indonesian Armed Forces (TNI AD), while he was the university’s internal reviewer.
According to him, the internal reviewer team and BPOM shared the same view that the drug development methodology and procedures were not in accordance with the good clinical practice (GCP).
“For the time being, it was not rejected but [they were not allowed] to continue [the process before] fixing it. Unair accepted it,” Windhu said.
BPOM also stated that the homegrown vaccine development had not met the GCP principles and submitted corrections for the result of the phase-1 clinical trial. However, the team insisted on entering the next stage of clinical trials without having BPOM’s permit.
Windhu argued that the Nusantara vaccine team should have accepted BPOM’s decision as the Unair team did. The agency did not mean rejecting the vaccine candidate initiated by former Health Minister Terawan, but rather asking the team to make improvements.
BUDIARTI UTAMI PUTRI