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Jakarta, CNBC Indonesia – The director of the Food and Drug Supervision Agency (BPOM), Penny Lukito, revealed the latest information on Covid-19 vaccines and vaccines in Indonesia. Currently the Chinese vaccine is in the process of preparation Emergency use authorization (USA) or for emergency use, after it has been declared that you have complied with the proper manufacturing method (CPOB) in your country of origin.
According to Penny, the government is committed to vaccinating with vaccines that meet the safety and efficacy properties. Currently, stages are also being prepared so that vaccinations can be carried out, both in emergency permits and in how to make good medicines (CPOB).
“We can report from the aspects of quality and vaccines, with the results of the inspection by the team of BPOM, MUI, Bio Farma, it can be said that the product has complied with CPOB (a good way of making medicine) in the facilities Chinese. clinical trials in Bandung and the results of clinical trials conducted in other countries such as Brazil, “Penny said in a virtual conference on Thursday (11/26/2020).
He said that the results of clinical trials, which consist of analysis of blood samples, immunogenicity based on scientific evidence, then safety aspects for efficacy after the second injection, and the latest developments will be reported by the research team that will be monitored for the next 3 months.
“We need a vaccine that is of good quality and safety, but also of good efficacy that will be seen in the immunogenicity of how to generate antibodies in the body and how to neutralize the viruses that enter our body. This stage takes time,” he said.
For the most recent data, show one month and readiness for three months. Penny said the one-month data is quite encouraging and will be confirmed with data from the 3-month efficacy analysis conducted in December 2020. These data are required for the BPOM process to evaluate with the Drug Evaluation Expert Team of Komnas to assess its viability.
“Later, we are waiting for the data. So far, data 1 shows good data of its efficacy and efficacy. We are positive, we are waiting for the next data for the process to work well. There will be observations in the next 3 months,” said Penny .
He also emphasized the government’s commitment to provide vaccines even if expedited, even with approval that is based on scientific data and shows guarantees related to good quality and sufficient efficacy. Although there will be a vaccine later, the Head of BPOM said that people must still wear masks and carry out health protocols in prevention.
“My hope is, of course, that we are still awaiting a proper data analysis process so that BPOM can provide EUA (emergency use authorization),” he continued.
Earlier, the chairman of the Covid-19 Management Working Group, Doni Monardo, asked the public to strictly adhere to health protocols, while waiting for the Covid-19 vaccine to be available. This will prevent people from getting infected with the Covid-19 corona virus.
“The best vaccine now is a vaccine that adheres to health protocols. #Pakaimasker, # stay away from the crowd and # wash as often as possible with soap and running water or with a disinfectant liquid,” concluded Doni Monardo.
[Gambas:Video CNBC]
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