by Mathias Hariyadi

A few days ago, Indonesian President Joko Widodo said vaccines by China’s Sinovac would arrive in Indonesia by this November. He later stated that after arriving in Indonesia, they will have to be inspected by Indonesia’s state-owned Bio Pharma.

 

Jakarta (AsiaNews) – Indonesia’s Food and Drug Authority has postponed vaccinations until January 2021, announced Indonesia’s Health Minister Agus Terawan Putranto, a former army lieutenant general.

They had been set to take place by the end of November at the latest. But this might change, as a new decision is likely to come shortly based on various health and risk considerations.

A few days ago, Indonesian President Joko Widodo said that the Sinovac vaccines would arrive in Indonesia by this month. But he later clarified that after arriving in Indonesia, they would have to be inspected by Bio Pharma, a state-owned pharmaceutical company.

“We have to conduct regular testing first by the Indonesian Food and Drugs Authority (BPOM). The fundamental principle of caution must be our concern,” the president said on Monday.

BPOM’s chief, Penny Lukito, expressed the same concern to the House of Representatives, the lower house of Indonesia’s parliament.

She told the house that it is paramount to implement health protocols and Emergency Use Authorisation" (EUA) as part of the COVID-19 vaccination programme, as China’s Sinovac vaccines will be used in Indonesia.

"Three key considerations should first be made and addressed before an EUA can be issued,” she said, namely “Quality, (health) safety, and efficiency in phases one, two and three of the clinical trials.”

Safety and efficiency data are not yet available

“Data on quality were made available to BPOM by Sinovac and are clearly valid and complete. But health safety and efficiency data will not likely be available until the third week of December,” Lukito explained.

“We have not yet received the result of the third phase of the clinical trial and Brazil has not yet obtained the expected result of the third phase of the clinical trial," she added.

"This means that an EUA cannot be issued in the second or third week of December" since Chinese and Brazilian health authorities are unwilling to provide the findings from their phase three trials.

“Based on our data, it will be impossible for us to issue an EUA as previously planned for December 2020,” Lukito said.

For this reason, vaccination will probably take place in the third week of January, once findings are in from China and Brazil, as well as those from Bio Pharma’s third phase trials in Bandung, West Java.

A few days ago, Indonesian President Joko Widodo confidently asserted that an EUA would be made in December. He even volunteered to be the first to take part in the vaccination programme, taking risks for his health for the good of the country.

Asked by a lawmaker if it is still possible to conduct the vaccination programme, Lukito replied that a health protocol approved by World Health Organisation is in place.

Any country could carry out the vaccination programme using only one quality data; this is what China did, with certain groups, like health workers and the military.

"Under Indonesia’s own health regulations, vaccination could also be done using the vaccine that is being tested, but which provides quality data.

“The data on quality have been confirmed to us, but we have not yet been able to get data on safety and efficiency.

Two vaccination groups

Indonesian Health Minister Putranto said the national vaccination programme will follow a two-pronged approach. A first group of 32 million people will require at least 73.96 million doses.

"Two doses per person, based on WHO's global rate, will have a 15 per cent waste rate," Putranto said, quoted today on the Health Ministry’s official website.

The second "independent" vaccination group includes at least 75 million people and this requires 172.6 million doses of the vaccine.

At least 67 per cent of some 160 million people between the ages of 18 and 59 will thus be vaccinated, according to Indonesia’s Ministry of Health.

"This programme is primarily aimed at people who are physically healthy, without any pre-existing condition, pregnant women or those previously infected with SARS-CoV-2 as officially recommended by the Indonesian Technical Advisory Group on Immunisation,” the minister said.

• indonesia
• covid-19
• pandemic
• vaccine
• testing
• quality
• safety
• efficiency
• data
• sinovac