Indonesia's Bio Farma and China's Sinovac to begin final clinical trials for Covid-19 vaccine

Indonesia is expediting efforts to come up with effective vaccines within a period of months.
Indonesia is expediting efforts to come up with effective vaccines within a period of months.PHOTO: REUTERS

JAKARTA - 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, disclosed on Tuesday (July 21) that the phase three clinical trials would begin next month with vaccine candidates from China's 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 Correspondent Club (JFCC).

Sinovac is not only doing clinical trials in Indonesia, said Mr Budi, adding that the Chinese company is also concurrently doing the same in Brazil, Turkey, Bangladesh and Chile, but the one in Indonesia has 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 candidates would have to be licensed by the country's Food and Drug Monitoring Agency (BPOM), 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 normally would take years.

Unlike most of the efforts elsewhere on a vaccine, Sinovac's is based on 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 novel coronavirus, which 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 can begin.

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

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.