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

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

Head of the Food and Drug Supervisory Agency (BPOM), Penny K Lukito (in white), during a visit to a venue of the COVID-19 vaccine phase III clinical trial in West Java on Tuesday (August 11, 2020). (ANTARA/HO-BPOM)

Jakarta (ANTARA) - 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 trials is in accordance with the CUKB protocol and principles, especially for researchers and sponsors, she said.

"The implementation of good clinical trials will produce valid data and can be accounted for ethically and scientifically as a product that is safe, high quality, and has efficacy. This is the task of the BPOM in overseeing the efficacy and safety of drugs before and after distribution," she said.

She said she hoped the public would play an active role by becoming wise in responding to information related to COVID-19, especially from social media platforms.

“Let us not easily fall for information that comes from sources that cannot be accounted for,” she cautioned. (INE)

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