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Judul : COVID-19 vaccine entered Indonesia under special access
scheme: BPOM

Nama Media : antaranews.com

Tanggal : 12 Agustus 2020
Halaman/URL : https://en.antaranews.com/news/153990/covid-19-vaccine-
entered-indonesia-under-special-access-scheme-bpom

Tipe Media : Online

Head of the Food and Drug Supervisory
Agency (BPOM), Penny K Lukito, has said
the vaccine candidates for COVID-19 that
have come in from China have entered
Indonesia under a special access scheme
mechanism.

“The COVID-19 vaccine from China's
Sinovac, that was imported to Indonesia,
went through the special access scheme
agreement mechanism,” Lukito told reporters in Jakarta on Tuesday.

The agency, she said, will also provide assistance in the vaccine registration process
through the Emergency Use Authorization mechanism, with a conditional agreement
to accelerate the opening of COVID-19 access for the people.

The COVID-19 vaccine, she said, is currently in phase III of clinical trials. The
research and development of the vaccine has involved Indonesia's Bio Farma and
China's Sinovac.

There has been transfer of technology for local vaccine production development in
the partnership, which is aimed at fulfilling the access needs and availability of
COVID-19 vaccine for Indonesians.
"Sinovac's COVID-19 vaccine has gone through a series of pre-clinical and phases I
and II clinical trials in China. Based on the results obtained from the clinical trials, the
agency has carried out evaluations which showed results that support the
commencement of phase III clinical trials," she explained.

Aside from Indonesia, the third phase of the clinical trial will be and is being carried
out in Brazil, Chile, Bangladesh, and Turkey.

Lukito explained that one of the agency's duties and functions as a drug authority is
to conduct surveillance on clinical trials, which starts with the provision of Approval
for Clinical Test Implementation (PPUK) and inspection of Good Clinical Test
Methods (CUKB).

The Good Clinical Trial Practice Inspection to ensure the implementation of clinical