Tuesday, 24 Nov 2020

Indonesia's flip-flops on vaccine programme causing doubts in grassroots, MPs say

JAKARTA – The Indonesian government’s flip-flops over the timing of a Covid-19 vaccination roll-out has cast doubts that an earlier announced mass vaccination programme will start in December this year.

At a parliamentary hearing on Tuesday (Nov 17), several Members of Parliament noted that the delays have sparked doubts among the public on the safety and effectiveness of vaccines being developed, with some people expressing their reluctance to be vaccinated.

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

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

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 drug maker Bio Farma and the University of Padjadjaran are jointly conducting phase 3 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 are 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 3 clinical trial in Indonesia, in which more than 1,600 volunteers underwent a randomised, double-blinded, and placebo controlled study.

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

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“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,” committee member Ms Putih Sari told the minister.

Another committee member Ms Angia Ema Rini said that many Indonesians do not have trust in the vaccine candidates the country is testing.

“The government can go ahead and announce it is ready to start vaccinations when clinical trials are completed and show no problems. Otherwise, people would be scared participating in the vaccination programme,” Ms Angia added.

FINAL STAGE

The phase 3 trial, the final stage a vaccine candidate must clear before it is given the go-ahead for use, had started in Indonesia in August.

Sinovac began developing the inactivated vaccine in January and cited positive results in the middle of the year from phase 1 and 2 clinical trials in China, with no reports of adverse effects.

It has since completed phase 3 clinical tests in China.

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

“In normal times, the World Health Organisation (WHO) says 70 per cent is required. In a pandemic, 50 per cent suffices,” Ms 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, presented slides at the hearing to show that the vaccination programme would cover 67 per cent of the population aged between 18 and 59, or 107.2 million people.

The government will cover the vaccination costs for 30 per cent of this group, and the remaining 70 per cent would have to pay their own way.

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Mr Budi said Indonesia is among several countries relying on vaccines from Sinovac, the United States’ Novavax and Gavi, a public-private health partnership whose objective is to increase access to immunisation worldwide.

The deputy minister in the hearing said that the locally developed Merah Putih vaccine may only be ready in late 2021 or early 2022.

Any vaccine candidate used widely in Indonesia would have to go through BPOM’s approval process, Dr Penny said.

She added that 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 her agency.

“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 in December.

According to the US Food and Drug Administration website, compassionate-use or expanded access is a potential pathway for a patient with a life-threatening condition to gain access to a drug being investigated for treatment outside of clinical trials.

It is used when there is no satisfactory alternative therapy to treat a disease.

When pressed by the lawmakers whether the government would start rolling out the vaccination programme in December, Health Minister Terawan said: “The sooner the better, but safety is priority.”

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