Coronavirus Vaccines

Rising uncertainty over Indonesia's vaccine programme

Delays in roll-out have led to doubts about safety of vaccine candidate in final-stage trial

A volunteer taking part in a Covid-19 vaccination drill in Bogor, West Java. Indonesia's state drugmaker Bio Farma and the University of Padjadjaran are jointly conducting a phase three clinical trial of a vaccine candidate, CoronaVac, which is being
A volunteer taking part in a Covid-19 vaccination drill in Bogor, West Java. PHOTO: AGENCE FRANCE-PRESSE
Indonesian President Joko Widodo's administration had earlier announced that a vaccination programme will begin this month, but last week told Reuters it will be by the end of this year. PHOTO: AGENCE FRANCE-PRESSE
Indonesian President Joko Widodo's administration had earlier announced that a vaccination programme will begin this month, but last week told Reuters it will be by the end of this year. PHOTO: AGENCE FRANCE-PRESSE

The Indonesian government's flip-flopping over the timing of a Covid-19 vaccination roll-out has cast doubts that a mass vaccination programme announced earlier will start next month.

At a marathon parliamentary hearing on Tuesday, several Members of Parliament noted that the delays have sparked uncertainty among the public about the safety and effectiveness of the vaccines being developed, with some people expressing their reluctance to be vaccinated.

President Joko Widodo's administration had earlier announced that a vaccination programme will begin this month, but last week told Reuters it will be by the end of this year.

At the hearing, Dr Penny K. Lukito, head of Indonesia's food and drug agency BPOM, ruled out emergency-use authorisation next month.

She told MPs that six months' worth of trial data need to be analysed before the independent agency can issue such authorisation.

Indonesia's state drugmaker Bio Farma and the University of Padjadjaran are jointly conducting a phase three clinical trial of a vaccine candidate, CoronaVac, which is being developed by China's Sinovac Biotech.

The Straits Times understands that there has not been a report of negative effects on volunteers involved in the trial, which is being conducted in Bandung, West Java.

The volunteers will have their next medical examination and blood test on Nov 24.

Dr Penny said Bio Farma is scheduled to release in January data from the phase three clinical trial, which involves more than 1,600 volunteers.

The interim analysis would serve as a basis for Bio Farma to file for an emergency-use approval for the CoronaVac vaccine, she added.

At the same health committee hearing, Health Minister Terawan Agus Putranto said no clear schedule for a mass vaccination programme can be confirmed yet.

Committee member Putih Sari told the minister: "The government's statements keep changing and it has caused doubts... If our clinical trials have not been completed, refrain from making announcements and don't make promises."

Another committee member, Ms Angia Ema Rini, said that as a result of the delays, many Indonesians do not have trust in the vaccine candidates the country is testing.

Final stage

The phase three trial, the final stage a vaccine candidate must clear before it is given the go-ahead for use, started in August.

Dr Penny said that if CoronaVac triggers an antibody response in at least 50 per cent of the volunteers who were given the vaccine shots, it would be enough for her agency to issue emergency-use approval.

"In normal times, the World Health Organisation says 70 per cent is required. In a pandemic, 50 per cent suffices," Dr Penny told MPs at the hearing.

State-Owned Enterprises Deputy Minister Budi Gunadi Sadikin, who heads the economic recovery desk in the government's Covid-19 task force, said the vaccination programme would cover 67 per cent of the population aged between 18 and 59, or 107.2 million people.

Dr Penny said there is an option for compassionate-use authorisation, which would allow the use of the vaccine in restricted groups, such as medical workers.

Unlike emergency-use authorisation, a compassionate-use approval does not require clinical trial data to be reviewed by BPOM.

"On the request of the Health Minister, BPOM may issue compassionate-use authorisation. Other countries do this as well," Dr Penny said, noting that in this case, Indonesia could start rolling out a vaccination programme next month.

When pressed by lawmakers on whether the vaccination programme would begin next month, Minister Terawan said: "The sooner the better, but safety is priority."

 
A version of this article appeared in the print edition of The Straits Times on November 19, 2020, with the headline 'Rising uncertainty over Indonesia's vaccine programme'. Print Edition | Subscribe