BANDUNG - The word of agreement from the Research Ethics Committee of Padjadjaran University is being awaited by the research team of the Faculty of Medicine, one of the proud campuses of the city of Bandung. This campus together with Bio Farma and Sinovach Biotech, China, are preparing a clinical trial for the Covid-19 vaccine. The vaccine from China will be injected into 1,620 volunteers in Bandung City according to the vaccine clinical trial procedure.
The head of the FK Unpad research team Prof. Dr. Kusnandi Rusmil, dr., Sp.A (K), MM, explained that clinical trials can only be done if you get the green light from the Unpad Research Ethics Committee. The current status of clinical trials is still in the stage of a feasibility review by the Ethics Committee.
"Once the Ethics Committee is okay, we will walk," said Prof. Kusnandi when interviewed by the Unpad Public Communication Office, as we reported on the official website of this campus, Thursday, July 16.
The volunteers - who are in good health - will get two shots of the vaccine. The duration of injection is 14 days. During that period, the team will supervise and inspect each volunteer for 7 months.
We look for healthy people, then we inject the vaccine, whether the vaccine gives rise to anti-disease substances or not.
Prof. Dr. Kusnandi Rusmil
The vaccine material is taken from a virus that has been killed. This method is considered to be cheaper and easier than developing a vaccine from the virus wall or its RNA.
Once discovered, vaccines are not automatically tested on humans. The first step is to test the vaccine on the animal body. If the animal is in a stable and stable body condition, the vaccine may be tested on humans.
Three phases of clinical vaccine trialsThe human clinical trial phase consists of three phases. The first phase was tested on 100 adults. If it is declared safe, the trial will enter the second phase, which is testing for at least 400 people. If successful, enter phase 3, with the number of volunteers reaching thousands of people. What needs to be known, clinical trials in Bandung City are testing in phase 3.
Phase 3 trials cannot be carried out in just one testing center, but must be carried out in multiple locations. Therefore, the Covid-19 vaccine clinical trial was not only carried out in Indonesia, but also in a number of countries in the world.
"The results of the trial in phase 3 must be the same. If the results are not the same (in every country), vaccines cannot be sold," said Prof. Kusnandi.
The scientist who has conducted 30 clinical trials of the vaccine said that, from the results of his analysis, the vaccine will create immunity against the Covid-19 virus in 28 days. If it has been approved by the Ethics Committee, the injection process will be carried out in 6 places, including: Unpad Teaching Hospital, Dipati Ukur Unpad campus, and 4 Puskesmas in Bandung City.
He ensured that this clinical trial still paid attention to the safety of volunteers. These preventive measures have been included in the work plan which is currently being reviewed by the Ethics Committee. "The person is insured,"
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