"The government guarantees (vaccine) distribution to various regions in Indonesia, and (that it) can be effective without destroying the quality of the vaccines," Wiku Adisasmito, spokesperson for the COVID-19 task force, said during a press teleconference from the Presidential Office in Jakarta on Tuesday.
Citing an example, he said when the government received millions of doses of the vaccine twice from China’s Sinovac at the Soekarno-Hatta Airport, Banten on December 6, 2020, the Food and Drug Supervisory Agency (BPOM) issued a lot release certificate as part of efforts to safeguard the quality of vaccines.
Currently, the process of distributing vaccines to various regions in the country is being carried out under close supervision.
"Vaccines currently being distributed to various regions will be monitored by conducting risk-based sampling at the task force unit of BPOM at the provincial, district, city levels throughout Indonesia," Adisasmito said.
Even though vaccine distribution has begun, he said, the administration of the vaccines is pending emergency-use authorization (EUA) from the BPOM. The BPOM is currently monitoring and evaluating the clinical trial stages of the vaccine.
Adisasmito said he was not sure when the permit for emergency use authorization will be issued. However, he added, he hoped that the permit will be issued as soon as possible so that vaccinations can be carried out immediately.
"The BPOM has carried out monitoring and evaluation of the procurement of vaccines on a regular basis from the preclinical stage to the Phase 1, 2 and 3 clinical (trial stage), which are currently underway in Bandung and in Brazil as well as in Turkey. Furthermore, when Phase 3 clinical trials are completed, then an emergency use authorization will be issued," he said.
The Drug and Food Control Agency (BPOM) earlier conducted clinical tests for China’s Sinovac vaccine and discovered two types of data indicating its safety, based on the results of its administration in the past couple of months.
The two types of data pertain to the vaccine’s immunogenicity and efficacy, BPOM spokesperson for COVID-19 vaccination Lucia Rizka Andalusia noted.
"This vaccine is quite safe. It has no serious side effects on its users," Andalusia noted during an Alinea Forum on ‘Halal and Security of COVID-19 Vaccine’.
The BPOM spokesperson revealed that the immunogenicity data has indicated a good immune response in the body resulting in antibody production.
The data may help dispel lingering doubts about the vaccine among the public, she stated.
The BPOM is currently awaiting more data sets from other clinical tests, she noted.
Andalusia affirmed that clinical testing offered several advantages to Indonesia, including an opportunity to gather clinical data and gain experience in the use of the vaccine. (INE)
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Translator: Indra A, Azis Kurmala
Editor: Suharto
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