Indonesia Testing Location for China’s Sinovac Phase 3 Clinical Trial

Aug 8, 2020 | CoronaVac, Coronavirus, COVID-19, Indonesia, News, PT Bio Farma, Sinovac, Vaccine

Indonesia Testing Location for China’s Sinovac Phase 3 Clinical Trial

Sinovac, one of the leading COVID-19 vaccine developers, initiated Phase 3 clinical trial in Indonesia where about 800 participants have registered for the clinical trial. Led by Padjajaran University (Unpad), Medical School’s Kusnandi Rusmil reports the clinical trial will commence on August 11. Thus far, they have only met half of their target in terms of a total of 1,620 volunteers. Volunteer registrations continue through at least until August 31.

Indonesia: A Big and Important Place

As the world goes, Indonesia is an important place. With about 270 million residents, it’s the fourth most populous country after the United States. Although its economy ranks 16th worldwide, its GDP has crossed $1 trillion; the emerging economy, based on population, age, and proximity in Southeast Asia, will continue to become more important. A fascinating place, over 300 ethnic groups call Indonesia home. According to some reports, hundreds of “living languages” are spoken. TrialSite suggests Indonesia could become more paramount to the global biopharmaceutical industry due to large diversified populations needing better healthcare, lower overall costs to run studies as compared to the West, treatment naïve population, higher numbers of infectious and chronic diseases, and ever-improving regulatory conditions; not to mention a growing middle class. Perhaps the Chinese biopharma industry knows this more than the West?

The Research Sites

Six research sites have been identified for the pivotal Phase 3 clinical trials, including Unpad Pendidikan Hospital, an Unpad campus, and four community health centers known as “Puskesmas” in Bandung: Sukapakir, Garuda, Ciumbuleuit, and Dago. This major study is planned to run at least half a year. TrialSite reported on the ramping up of this study earlier in July.

PT Bio Farma Major Participation

Via a Sinovac license, PT Bio Farma (Bio Farma), a state-owned pharmaceutical company in Indonesia, is making and distributing the actual vaccine. The Jakarta Post reports that CEO Honesti Basyir reports the company is now conducting vaccine stability tests in its laboratories. The CEO commented, “It will take three to four weeks,” noting that the genome of the virus in Indonesia was 99.99 percent compared with the one in China, reports Arya Dipa with The Jakarta Post. Bio Farma seeks to boost productive capacity to produce 250 million of CoronaVac, the Sinovac COVID-19 vaccine, by the end of December 2020.

Dipa reported that Bio Farma will invest $88 million in infrastructure and human capital necessary for scaling out research and production for CoronaVac.

BPOM Participation

The local news reports Penny Kusumastuti with the Food and Drug Supervisory Agency, also known as BPOM, collaborates closely with Bio Farma and the research team to ensure these clinical trials are conducted in a safe and ethical manner. Kusumastuti reports that “BPOM has assisted the formulation of protocols and methodologies, and we have an ethics committee to ensure the implementation of clinical trials is ethical and those involved are protected.”

CoronaVac Purchase

The Indonesian government, via Bio Farm, has negotiated the right to purchase up to 100 million doses in a year. Mr. Basyir has been on the record study that the company has the capacity to produce up to 250 million doses per year.

SinoVac

The Chinese company needs a big hit. TrialSite has reported on investor challenges with this company. They recently secured a $15 million convertible debt deal. In 2019, the company triggered a rare “poison pill,” proceeding to protect existing management from disgruntled shareholders.

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