In a decree signed by Health Minister Terawan Agus Putranto on Dec. 3, the government has stipulated that the vaccines that can be used for vaccination programs in Indonesia must come from local pharmaceutical company PT Bio Farma, United Kingdom-based AstaZeneca, China’s Sinopharm or Sinovac Biotech, or US pharma Moderna. The vaccine being jointly produced by US firm Pfizer and German company BioNTech also made the list.
The decision came after the UK’s major step of approving the use of the Pfizer-BioNTech vaccine last week. In Indonesia, the candidate vaccines being produced by the companies are either entering or completing phase three clinical trials.
There have been disputes among regulators in various countries surrounding emergency authorization for the vaccines, since all of them have just finished or are in the early stage of human trials.
UK regulators in particular have been criticized for the Pfizer-BioNTech vaccine approval, with critics claiming that they compromised safety by skipping several parts of the process to speed up the authorization.
But the Medicines and Healthcare products Regulatory Agency (MHRA) has rebuffed the accusations, saying that it had used overlapping trials and "rolling reviews" since June to reach the determination in record time.
"That doesn't mean any corners have been cut – none at all," June Raine, its chief executive, said at a press conference. "The safety of the public will always come first."
The Indonesian Food and Drug Monitoring Agency (BPOM) said earlier it would not grant emergency use authorization (EUA) to a candidate vaccine from Sinovac in December because of a lack of data on its effectiveness.
“We have explained to the President that we cannot meet the deadline for emergency use authorization in the second or third week of December,” said BPOM head Penny Kusumastuti Lukito in a hearing at the House of Representatives last month. She said that approval could come in the third or fourth week of January 2021.
Read also: No emergency vaccine approval this year in Indonesia, says BPOM
The latest decree from the Health Ministry also stipulates that each candidate vaccine should obtain an EUA from the agency before it can be used for a vaccination program.
The government has also identified the priority groups for receiving the vaccine once it arrives in the country.
The first priority group comprises 3.5 million frontline workers, including health workers, contact-tracing paramedics, and military and law enforcement personnel.
The second priority group consists of religious and community leaders and local authorities at district, village, community and neighborhood units, who altogether comprise over 5 million individuals.
The third priority group includes more than 4 million teachers at various levels of education. The fourth group is government officials and legislatives council members with more than 2 million individuals.
The fifth group includes members of the Health Care and Social Security Agency (BPJS Kesehatan) whose fees are paid by the government. Their number exceeds 86 million individuals. The last group of more than 57 million is the general public. (wit)
Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise people’s awareness about the pandemic.