JAKARTA – Head of the Eijkman Institute for Molecular Biology, Amin Soebandrio, emphasized that clinical trials starting from stages 1-3 were carried out to ensure the safety and efficacy (efficacy) of vaccines. Including vaccines to prevent COVID-19 infection.
“Phase 1 is to test security. It was the first time it was injected into humans, so the number was small first, several tens of people, ”Amin said in Jakarta, Monday (14/12).
The vaccine testing looks at the results of a comparison between people who were vaccinated and those who did not receive the vaccine. In the COVID-19 pandemic, vaccines are tested whether they can create a person’s immune system against COVID-19.
In that clinical trial, one group received an injection that did contain a vaccine. While the other group received an injection that did not contain a vaccine.
“This is what is called a placebo. After that, the percentage of symptoms will be compared. For example, if the difference is very large or that causes symptoms, or does not exist at all. It was just declared safe. if it is safe, we can show that the risk is much smaller than the expected benefits, “said Amin.
Phase 2 clinical trials were conducted on several hundred people. At this stage, the results will be seen to determine the efficacy and determine the side effects of the vaccine.
If you have passed the clinical trials of stages 1 and 2 in sequence, then it is followed by stage 3. Namely the vaccine is given to thousands of people. The goal is to show vaccines are safe, effective and useful.
In clinical trials, it is also searched for the vaccine dose that best provides protection. But on the other hand, it is still safe and does not have a negative effect on vaccine recipients.
“Therefore, all vaccines must complete phase 1, 2 and 3 clinical trials with results that are targeted at creating a person’s immune system. However, even though the vaccine will be available later, the 3M health protocol (Wearing a Mask, Washing Hands, Maintaining Distance) still has to be implemented, “he concluded. (rh / fin)
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