Coronavirus Asia

Indonesia to get Brazil's trial data for vaccine approval

A vendor walking past a sign about Covid-19 prevention measures in Bandung, West Java, earlier this month. Indonesia's Phase 3 clinical trial of Sinovac Biotech's CoronaVac was poorly organised and failed to gather the data for the vaccine to be appr
A vendor walking past a sign about Covid-19 prevention measures in Bandung, West Java, earlier this month. Indonesia's Phase 3 clinical trial of Sinovac Biotech's CoronaVac was poorly organised and failed to gather the data for the vaccine to be approved.PHOTO: BLOOMBERG

With the slow development of its own Phase 3 clinical trial of a Covid-19 vaccine candidate, Indonesia said it has asked for data from Brazil, where a similar trial is progressing smoothly.

It expects to receive the safety and efficacy data on Chinese firm Sinovac Biotech's CoronaVac by next Monday, and hopes to finally start rolling out its vaccination programme next month.

A Phase 3 clinical trial is the final stage that a vaccine candidate must clear before it is given the go-ahead for use by a country's regulatory agency.

BPOM, the Indonesian equivalent of the US Food and Drug Administration, has requested the data through its Foreign Affairs Ministry, which then communicated with Brazil's National Health Surveillance Agency and Sinovac, said a government official who spoke on condition of anonymity.

"Within a matter of days after receiving the data, BPOM may issue its emergency use authorisation on the vaccine, when a thorough evaluation is done," the official told The Straits Times.

Brazil carried out a strict clinical trial on CoronaVac, which it started earlier than Indonesia, the official added.

BPOM's head Penny K. Lukito had earlier said a vaccine can be chosen as long as it has gone through the proper trials.

Indonesia has so far secured commitments for 189 million vaccine doses from Sinovac, US-based Novavax, as well as Covax, an international Covid-19 vaccine allocation platform co-led by the World Health Organisation.

Brazil, Indonesia, Singapore and Turkey are among the countries expected to use CoronaVac as part of their vaccination programme.

Indonesia, South-east Asia's most populous country, plans to vaccinate 107.2 million people aged between 18 and 59, out of its population of 270 million. Those with medical conditions or who are deemed unfit will not be included.

It has also set aside a buffer of 15 per cent for its vaccine stockpile.

Since the vaccine is given in two doses, it would need 247 million doses in its stockpile by next year.

Indonesia had planned to start its vaccination programme as soon as last month, but it had to be delayed, with a poorly organised Phase 3 clinical trial of CoronaVac failing to gather the data for the vaccine to be approved.

State-run drugmaker Bio Farma and the University of Padjadjaran in West Java, which began conducting the trial in August, have been unable to come up with an interim analysis, a prerequisite before BPOM can review the vaccine for approval for emergency use.

With only 1,600 volunteers in the trial and a lack of people who represent the risk groups - such as medical workers - among them, there is a lower chance that the required number of volunteers would be exposed to infections.

To test the efficacy of the vaccine candidate, at least 1.5 per cent of the 1,600 volunteers must have contracted the virus so that they can be monitored.

Brazil recruited more than 9,000 volunteers - including ample medical worker volunteers - in its clinical trial and has thus been able to make better progress.

A version of this article appeared in the print edition of The Straits Times on December 24, 2020, with the headline 'Indonesia to get Brazil's trial data for vaccine approval'. Print Edition | Subscribe