BPOM Accompanying Clinical Trial Of COVID-19 Vaccine From China To Speed Up Distribution Permits

Vaccine illustration (kfuhlert / Pixabay)

JAKARTA - The Food and Drug Supervisory Agency (BPOM) will accompany the third stage clinical trial process for the COVID-19 vaccine produced by PT Bio Farma (Persero) in collaboration with Sinovac Biotech Ltd. This assistance is carried out so that the vaccine can immediately obtain a distribution permit so that it can be used by the community.

"We will accompany the clinical trial process so that there is an acceleration in granting distribution permits," said Head of BPOM Penny Lukito in a press conference broadcast on the YouTube account of the Presidential Secretariat, Tuesday, July 21.

"So that later when the clinical trial is over, we will give permission for distribution so that it can be circulated and distributed," he added.

The clinical trial process for the vaccine was carried out by PT Bio Farma in collaboration with Padjadjaran University and the Health Research and Development Agency (Balitbangkes).

In testing, the vaccine developed by this Chinese company will be injected into 1,620 volunteers.

Regarding the phase three clinical trial process that will be carried out, Penny said this stage is very important. "It means, we almost found the vaccine because there is already preclinical, phase 1, phase 2, now the third phase," he said.

He also emphasized that the clinical trial stage currently being carried out has a valid method and this is guaranteed by the BPOM. "The POM guarantees that the protocol for this test is valid," he said.

Meanwhile, President Director of PT Bio Farma, Honesti Basyir, said that the company will prepare vaccine production of up to 100 to 250 million doses per year in the future.

"But for the first phase, in accordance with the target of the first clinical trial in January and the release permit, we are targeting completion of around 40 million doses per year," he said in the same press conference.

He ensured that his company would manage the production of this vaccine well so that the public could immediately use the results.

Previously, the Special Staff of the Ministry of BUMN, Arya Sinulingga, said that Bio Farma was entrusted with conducting clinical trials of the Sinovac vaccine by international pharmaceutical institutions. From the trials it will be seen whether the vaccine is compatible with COVID-19 currently circulating in Indonesia.

"Bio Farma is indeed a well-known position in the international community and is considered capable of conducting clinical trials and preparations. Don't be surprised if Bio Farma is trusted by several countries to be included," said Arya.