BPOM: Vaccination Only Permitted after Emergency Authorization is Issued

Translator

Ricky Mohammad Nugraha

Editor

Laila Afifa

Kamis, 7 Januari 2021 14:24 WIB

An official checks on coronavirus disease (COVID-19) vaccines from China's Sinovac Biotech Ltd. as they arrive at PT Bio Farma (Persero) in the first shipment to Indonesia in Bandung, West Java province, Indonesia, December 7, 2020. The vaccine still needs to be evaluated by the country's food and drug agency (BPOM) while his administration continues to prepare for distributing the vaccine across the vast archipelago of 270 million people. Courtesy of Muchlis Jr/Indonesian Presidential Palace/Handout via REUTERS

TEMPO.CO, Jakarta - The Food and Drugs Monitoring Agency (BPOM) stated that it is attempting to issue the emergency use authorization for the Covid-19 vaccine before January 13, the schedule set by the government for the inaugural vaccination.

BPOM vaccination spokesperson Lucia Rizka Andalusia said her office has evaluated the data through rolling submissions from the first and second clinical trials reports.

“Partial data has been obtained by the BPOM and are being evaluated. We are waiting for the final analysis that will be handed to the agency,” said Rizka on Thursday, January 7. “Soon after we obtain the data, we conduct the evaluation and are hoping to issue the emergency use authorization prior to the vaccination.”

The interim report on the vaccine’s third phase clinical trials had been obtained ahead of the initial plan at the end of January.

The government recently announced that Indonesia’s inaugural vaccination will begin on January 13, 2021, with the first recipient being President Joko “Jokowi” Widodo. It wil immediately be followed by the vaccination of healthcare workers in the frontline of the pandemic mitigation.

However, the House of Representatives (DPR) on Wednesday hoped that the BPOM is not pressured to issue the authorization under a certain time schedule. The DPR asserted that BPOM is limited to issuing permits on the vaccine’s safety-worthiness.

Read: MUI to Determine Covid-19 Vaccine Halal Status after BPOM Approval

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