Coronavirus: Indonesia's Bio Farma to begin advanced clinical trials next month

Bio Farma, which has been working with Chinese firm Sinovac on a Covid-19 vaccine since April, said Phase III trials would begin next month with vaccine candidates from Sinovac. If the trial is successful, production will begin in the first quarter o
Bio Farma, which has been working with Chinese firm Sinovac on a Covid-19 vaccine since April, said Phase III trials would begin next month with vaccine candidates from Sinovac. PHOTO: BIO FARMA/FACEBOOK

Indonesia's state-owned pharmaceutical company Bio Farma, which has been working with Chinese firm Sinovac on a Covid-19 vaccine since April, is set to begin the third and final phase of clinical trials on humans next month.

If the trial is successful, production will begin in the first quarter of next year with a maximum 250 million doses a year.

Sinovac has been looking for volunteers outside of China because Covid-19 has been largely contained in the country.

Testing a vaccine's efficacy in a late-stage trial usually requires thousands of people at a location where a virus is still spreading. Infections, as well as fatalities, continue to mount in Indonesia.

As many as 1,620 volunteers have come forward to participate in the trial that would jointly be conducted by Bio Farma and the University of Padjadjaran in West Java.

Mr Budi Gunadi Sadikin, a high-ranking member of the newly formed national economic recovery and Covid-19 response team, said yesterday that Phase III clinical trials would begin next month with vaccine candidates from Sinovac.

"We are working on the vaccines as well as the drugs to treat people if they are not sick. Both, to be honest, are in quite advanced stages, in terms of development," Mr Budi said in response to a question from The Straits Times during a panel discussion organised by the Jakarta Foreign Correspondents Club.

He added that Sinovac is doing clinical trials not only in Indonesia - the Chinese company is also concurrently doing so in Brazil, Turkey, Bangladesh and Chile - but the trials in Indonesia have reached the most advanced stage.

"It is important for the vaccine candidates to be tested across the world so that you can learn the response from different races with different genetic make-up," said Mr Budi.

In Indonesia, any vaccine candidate would have to be licensed by the country's Food and Drug Monitoring Agency, the equivalent of the United States Food and Drug Administration.

Like other countries affected by the Covid-19 pandemic, Indonesia is expediting efforts to come up with effective vaccines within a period of months, a process that would normally take years.

Unlike most vaccine efforts elsewhere, Sinovac's is based on an inactivated whole virus, a mature vaccine technology that has also been used to produce vaccines against influenza and polio. In contrast, many of the others are working on next-generation platforms that involve using the DNA or RNA of the coronavirus that causes Covid-19.

Bio Farma's president director Honesti Basyir said in a statement that the shipment of the vaccine candidates from Sinovac arrived in Indonesia on Sunday and would first need to be tested at the company's laboratory.

It would then have to get approval from the government before final clinical trials could begin.

"If the Phase III clinical trial runs smoothly, Bio Farma will start production in the first quarter 2021. We have lined up the required equipment," said Mr Honesti.

Bio Farma's head of research and development, Dr Neni Nurainy, told The Straits Times the company had the capacity to produce up to 250 million doses a year.

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A version of this article appeared in the print edition of The Straits Times on July 22, 2020, with the headline Coronavirus: Indonesia's Bio Farma to begin advanced clinical trials next month. Subscribe