BPOM Beware Of Giving Permit To Use The COVID-19 Vaccine

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JAKARTA - Director of Drug Registration at the Food and Drug Supervisory Agency (BPOM) Rizka Andalucia said that the BPOM is guided by the principle of prudence in issuing permits related to the distribution and use of the COVID-19 vaccine, including in granting emergency use authorization (EUA).

"For products that have obtained EUA, BPOM continues to supervise," said Rizka in a press statement delivered to journalists, reported by Antara, Monday, October 26.

He explained, BPOM carries out supervision starting from the vaccine production process to distribution from the pharmaceutical wholesaler level to pharmaceutical service facilities.

Previously, the Head of BPOM Penny Lukito said that it was possible to provide EUA for COVID-19 drugs and vaccines during a pandemic like now.

However, he stressed that EUA administration must be supported by evidence of safety, quality, and efficacy of drugs or vaccines as well as close supervision.

Supervision, he explained, includes evaluation of import realization reports, production and distribution processes, as well as reporting of side effects from doctors and related health workers.

"BPOM is very careful in ensuring the safety, efficacy and quality aspects of vaccines, amidst the acceleration of drug availability and certainty in getting access to vaccines," he said.

He added, BPOM is also supervising and inspecting the implementation of clinical trials for vaccines and COVID-19 drugs to ensure the implementation of the Good Clinical Test Method (CUKB).