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Mass Injection of Covid-19 Vaccine February 2021

Jakarta, CNBC Indonesia– PT Bio Farma (Persero) projects that Covid-19 vaccination can be given in early February 2021, after obtaining an emergency use authorization (EUA) from the BPOM.

Currently, Bio Farma still has to complete the data needed for EUA, namely a complete report on phase 1 and 2 clinical trials, and interim data on the phase 3 clinical trial of Sinovac Biotech’s Covid-19 CoronaVac vaccine which was conducted in Bandung, West Java.

“Until now, we are still progressing the clinical trial of 1,620 volunteers for the stage 3 clinical trial. Everything is running smoothly, there are no indications that it shows a serious incident. The plan is that the first week of January 2021 we will provide an interim report to get EUA from BPOM. mass vaccines, “said Director of Bio Farma Honesti Basyir, Wednesday (11/25/2020).


He added that in the third week of January 2021, it was hoped that an EUA would be given by BPOM. After that, the production process can be carried out with bulk raw materials obtained from China. Honesti said that currently his party is preparing a production facility so that it can run immediately after obtaining EUA.

“There are many questions whether the vaccine is effective, safe and lawful, this is one of the objectives of the clinical trials being carried out,” he said.

In phase three clinical trials, there are several aspects that are considered especially safety and efficacy. In addition, the phase 3 clinical trial carried out in Indonesia is also parallel in several other countries, namely Brazil and data exchange will be carried out for the process of obtaining a permit.

Previously, the BPOM said that an emergency permit to use the vaccine could possibly be given in the week of January 3-4, 2021 if all data were complete.

“We have not been able to get the clinical trial results from Brazil, they have already conducted the Sinovac clinical trial, and hopefully the data was already there but they need longer time for safety, immunogeneity and efficacy. They promise Januri the first week, and this adds “Sinovac vaccine safety guarantee and includes interim data on clinical trials in Bandung which will be given the first week of January,” said Head of BPOM Penny Lukito.

He said the requirement for EUA administration was that vaccines must have complete data on phase 1 and phase 2 clinical trials, as well as interim analysis data or three months of phase 3 clinical trials to show efficacy and safety. This EUA procedure refers to the emergency approval guidelines from the WHO (WHO Emergency Listing), the US Food and Drug Administration (EUA), and the European Medicines Agency / EMA (Conditional Approval).

(roy/roy)


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