BPOM: Terawan's Vaccine Falls Short on Requirements
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11 March 2021 00:23 WIB
TEMPO.CO, Jakarta - Head of the Food and Drug Monitoring Agency (BPOM), Penny K. Lukito said that she will meet with the team of researchers behind the ‘Nusantara Vaccine’ to conduct a clinical review before permitting the vaccine development to continue to the second and third phase.
“We will conduct an initial clinical trial review before moving to the second and third [clinical trials],” said Penny in front of a panel of Commission IX legislators during the House of Representatives (DPR) hearing on March 10.
She revealed that the Nusantara Vaccine’s first clinical trial has not fulfilled the requirement and cited its difference in research locations.
Penny said that the location of the vaccine’s development - led by former Health Minister Terawan Agus Putranto - is registered at the Kariadi Semarang General Hospital while the ethical committee comes from the Gatot Soebroto general hospital.
Another questionable aspect is the difference of data presented by the Nusantara Vaccine clinical trial team with the data presented in the Commission IX House hearing.
In an earlier session, Terawan asked for the supports from the Health Ministry and BPOM for the development of the Nusantara Vaccine.
Read: UGM Withdraws from Nusantara Vaccine Development
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