BPOM: Accelerating Vaccine Permits Still Prioritizing Benefits Aspects
BPOM is accelerating the delivery and use of the Covid-19 Sinovac vaccine.
REPUBLIKA.CO.ID, JAKARTA – The Food and Drug Supervisory Agency (BPOM) has accelerated the provision of Emergency Use Authorization (EUA) or use for the Sinovac vaccine. Head of BPOM, Penny K. Lukito said, although it was accelerated, BPOM was carrying out this process carefully.
“I think the EUA award will go through an accelerated process, but the benefits obtained are still higher than the existing risk aspects,” said Penny, in a teleconference, Wednesday (30/12).
He explained that the results of the Sinovac vaccine clinical trial conducted in Bandung continued to be communicated with similar tests carried out in Turkey and Brazil. In this communication, the results of clinical trials in three countries obtained consistent data.
Penny explained that the second injection had been completed and had been observed. “It has shown good data when it comes to safety. And reported no serious side effects,” he said again.
Currently, he continued, the research team is completing analysis data from the aspect of vaccine efficacy or effectiveness. In addition, it is also investigating how this vaccine neutralizes if the human body is exposed to the corona virus.
Penny said that the data generated so far have shown good results and have increased BPOM’s confidence as the party conducting the evaluation. However, his party is still waiting for three months of results data which will be given to BPOM at the beginning of the first week of January.
The data, continued Penny, will show efficacy data. At the same time, his party will also share data from clinical results in Turkey which he said showed good results, namely 91.25 percent.
“I think the other data are also consistent with the data obtained in Indonesia,” he said.