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Jakarta, CNBC Indonesia – PT Bio Farma (Persero) has completed the injection of the Covid-19 vaccine in 1,620 volunteers of the Covid-19 vaccine who are subject to the third phase of clinical trials. The next stage is the administration of a second injection and the observation of the efficacy and safety of the vaccine to the subject.
The president and director of Bio Farma Honesti Basyir said that the vaccination program, which is scheduled to take place next year for 170 million people or about 60% of the total population of Indonesia, must be properly protected.
So that the whole process is well managed from the beginning, starting from phase 3 of the clinical trial, from production to distribution from Bio Farma, from the provincial level to the health center level, including the health workers who provide the Covid-19 vaccine to the community.
Therefore, this Covid-19 vaccination program should be protected as best as possible from all concerned, so that this program can be run according to the procedures, and also run so that later the public is sure that the Covid-19 vaccine that will be administered to the community is in accordance with Agency regulations. “POM can ultimately stop the spread of the Covid-19 virus,” Honesti said in a press release, quoted on Sunday (10/18/2020).
Under surveillance conducted by the POM, until the subject’s last injection last week, there were no reports of Post-Immunization Follow-up Incidents (AEFI) or serious or serious side effects among the Covid-19 vaccine volunteers.
The Director of Drug Registration of the POM, Riska Andalucía, said that the POM has a supervisory and advisory role in the clinical trial process that is currently being carried out. Results from this clinical trial in Bandung will later be combined with phase three clinical trials from Brazil, Chille, Turkey and Bangladesh for this CoronaVac vaccine.
Once the phase 3 clinical trial is finished, the Covid-19 vaccine will be produced by Bio Farma, and of course in this production process it must comply with the quality / quality aspects and Bio Farma will continue to be under the supervision of the POM Agency to comply with the Good Manufacturing Practices regulations. Good medicine.
“These three aspects, efficacy, safety, and quality, must be met by Bio Farma, as a registrant for the Covid-19 vaccine to be declared feasible or not by the POM to produce and distribute,” said Riska.
Additionally, POM RI Director Penny K. Lukito stated that the assistance provided by the institution she leads is expected to expedite the process of issuing an Emergency Use Authorization (EUA) for the vaccine in the future.
During the vaccination period for all subjects in Bandung, the POM stated that there were no excessive reactions or serious adverse events, only mild reactions as in general immunization.
“In addition, the POM will conduct regular monitoring to obtain comprehensive data on the efficacy and safety of the vaccines required for US administration,” Penny said in a separate statement.
It revealed that clinical trials are an important stage in research / development to obtain valid efficacy and safety data to support the Covid-19 vaccine registration process.
