President Joko Widodo, right, accompanied by Health Minister Terawan Agus Putranto speaks at a press conference after observing the Phase 3 clinical trial at the Faculty of Medicine, Padjadjaran University, in Bandung on Tuesday. (Antara Photo/Dhemas Reviyanto)

Indonesia Starts CoronaVac Phase 3 Clinical Trials

BY :BERITASATU & JAYANTY NADA SHOFA

AUGUST 11, 2020

Jakarta. Phase 3 clinical trial on coronavirus vaccine candidate CoronaVac has begun in Bandung, West Java, on Tuesday.

CoronaVac is developed by Chinese pharmaceutical giant Sinovac Biotech, who has selected its Indonesian counterpart Bio Farma to run the late-stage clinical trial at a facility belonging to Padjadjaran University's Faculty of Medicine.

On the first trial, at least 20 out of 1,620 volunteers had taken the first shot of the CoronaVac. President Joko "Jokowi" Widodo was also present to observe the trial in person.

"Hopefully, we will be able to produce the vaccine in January 2021. Once the production is ready, [we can vaccinate] everyone in the country," Jokowi said in Bandung.

The president expects that the clinical trial should be completed in six months.

Bio Farma plans to produce 100 million doses of vaccine in August. They will also ramp up their production capacity up to 250 million vaccines by the end of this year, Jokowi said.

Meanwhile, half of the 1,620 volunteers will be injected with the potential vaccine. The rest will receive a placebo or an inert substance which serves no therapeutic value. This is done to compare the effects on those who have been vaccinated and those without.

As of Monday, Unpad's research team has already mustered up to 1,020 people as volunteer candidates.

West Java Governor Ridwan Kamil has signed up to partake in the CoronaVac clinical trial. Also lining up as a potential test subject are West Java Police Chief Insp. Gen. Rudy Sufahriadi and Siliwangi Military Command Commander Maj. Gen. Nugroho Budi Wiryanto.

If qualified as a volunteer, Ridwan promised that he would follow all necessary procedures without receiving any special treatment despite being the governor.

"If leaders participate [in the clinical trial], the public will be assured that all processes are carried out scientifically. There is no such thing as 'sacrificing people'," Ridwan said.

The CoronaVac volunteer is selected based on many criteria.

Any candidate must first undergo both rapid test and PCR test to prove they are virus-free. The trial is limited for healthy people aged 18-59 years old. Only Bandung citizens are allowed to join as they must remain in the city until research completion.

Red and White

CoronaVac is not Indonesia's only ray of hope for immunity against the pneumonia-like disease.

Other potential vaccines are also in the works, including the country's very own Merah Putih (Red and White) vaccine which is named after the colors of the Indonesian flag.

For the past three months, a national consortium of government and private institutions under the Research and Technology Ministry are working on the Red and White vaccine.

According to Jokowi, Red and White's development uses an isolate from the coronavirus that has been spreading in the country. The vaccine is likely to be ready by mid-2021.

There is also one key difference between CoronaVac and Red and White.

The former uses a single virus which will be multiplied in the lab and later separated prior to inactivation. By inactivating or killing off the virus, the vaccine candidate is safe for human use. In comparison, Red and White only takes certain parts of the virus considered to be important to be multiplied and used as antigen.

Red and White vaccine is scheduled to complete animal testing by the end of this year. If effective, Bio Farma will conduct its pre-clinical and clinical trials.

Teamwork Makes Dream Work

The president said that the country is open for partnership on Covid-19 vaccine.

"By opening ourselves [for cooperation], we can vaccinate all Indonesian people as soon as possible," he said.

Apart from Sinovac, pharmaceutical firm Kalbe Farma has joined forces with South Korea's biotech firm Genexine to run a phase 2 clinical trial for a DNA vaccine.

State-owned pharmaceutical company Kimia Farma has discussed a potential partnership on a phase 3 clinical trial with the G-42. The latter is an Abu Dhabi-based artificial intelligence and cloud-computing company.

"The draft for MoU [between Kimia Farma and G-42] is currently waiting to be finalized and hopefully will be signed in the second week of August," Foreign Affairs Ministry spokesperson Teuku Faizasyah has said earlier.

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