4 yıl önce

Indonesia kicks off human trials with Chinese Covid-19 vaccine

The candidate is among few potential vaccines that have entered late-stage trials for a large-scale study to gather proof of efficacy for regulatory approval.

AFP

A doctor shows the box of a Covid-19 vaccine produced by Sinovac Biotech at the Sao Lucas Hospital, in Porto Alegre, southern Brazil on August 8, 2020.

China's Sinovac Biotech Ltd has launched a late-stage human trial involving as many as 1,620 patients in Indonesia for a Covid-19 vaccine candidate that it is developing with Indonesian state-owned peer Bio Farma.

The candidate, known as CoronaVac and previously PiCoVacc, is among few potential vaccines that have entered late-stage trials for a large-scale study to gather proof of efficacy for regulatory approval.

CoronaVac is already undergoing a late-stage trial in Brazil slated for as many as 9,000 people.

Its Indonesia trial comes as Southeast Asia's most populous country grapples with spiking infection numbers, with over 127,000 cases recorded as of Tuesday.

#GoodNews: #Indonesia is set to start the phase III clinical trials of #COVID19 #vaccine developed by #China-based Sinovac Biotech today (11/8) in 6 different locations in Bandung:Unpad Pendidikan Hospital, 1 Unpad campus, health centers of Sukapakir, Garden, Ciumbuleuit & Dago. pic.twitter.com/5A5Y1RnWDa
— Ambassador Deng Xijun (@China2ASEAN) August 11, 2020

Trial to take 6 months

The trial has so far recruited 1,215 people and will last six months.

If the vaccine proves safe and effective, Indonesian officials said, there were plans to produce up to 250 million doses for the sprawling archipelago of nearly 270 million, although they gave few details of the tentative roll-out.

A ceremony for the launch on Tuesday in Bandung, West Java, was attended by Indonesia's President Joko Widodo.

"The threat of Covid-19 will not subside until a vaccine is given to all the people," Widodo said.

Sinovac expects to also test the vaccine candidate in Bangladesh.

Separately, Sinovac late on Monday released details from a mid-stage, or Phase 2, study in which it said the vaccine candidate appeared to be safe and induced detectable antibody-based immune responses in subjects.

In the Phase 2 clinical trial involving 600 participants in China, the candidate did not cause any serious side effect and the rate of fever was relatively low compared with other Covid-19 candidates, the paper showed ahead of peer review.

Sinovac has to test its vaccine abroad because China is no longer a satisfactory site for late-stage trials due to the low number of new infection cases.