Merdeka.com – When Indonesia was undergoing clinical trial phase 3 of the Sinovac vaccine in Bandung. This third clinical trial is not only held in Indonesia but in several other countries such as Brazil. To arrive at a phase or stage 3 clinical trial, a vaccine candidate must first go through several other testing stages, whether tested on humans or not.
“First, the owner or who will make the vaccine first identifies the candidate vaccine. The candidate vaccine name. The best chosen one is of course the one that can produce anti-substances, the antigen researcher looks for. Then what part will we use, whether all viruses, whether the viruses that are on or off, or only the part called protein on the surface, ”explained Professor of the Faculty of Medicine, University of Padjajaran, Prof. Dr, dr Cissy Rachiana Sudjana Prawira-Kartasasmita on a live broadcast on Youtube Against Covid 19 ID.
This test is called a pre-clinical test and is tested on animals first. Animals that are usually used for testing are monkeys, mice, or hamsters. If the results are safe and produce a strong immune response, the pre-clinical trial is considered safe and the vaccine will continue its testing.
Vaccine candidates who fail to pass the test phase will not continue to the next phase of clinical trials tested in humans. The human clinical trial phase consists of 3 stages plus one phase which is post marketing.
“Phase 1 is to test safety and effectiveness. Safety and effectiveness. So to see if by injecting into a small number of people under 100 people there will be an immune response. So the body reacts, we’ll measure the antibodies later. “
In this phase, vaccine makers will also see if those who are injected with the vaccine suffer from certain diseases or side effects. If it does cause a side effect or disease, it will be seen again what the disease looks like. If this phase shows good results and post-immunization follow-up events (AEFI) are not severe, then testing will continue to the second phase.
“In phase 2, the safety is seen again. Make (phase 1) only a few (volunteers), (second phase) more people, more injections, varying the person. But usually all healthy people, yes, no sick. “
In phase 2, testing is usually divided into two groups, namely the group that received the vaccine and the group that did not get the vaccine, namely the placebo or control group. Those who receive the vaccine will be seen again how much the vaccine is and if the injection has to be done twice, the antibody level will be seen after two injections. If the results are safe, then the test will resume to phase 3.
In the third phase, testing is carried out to find out if there are rare side effects from the injection of this vaccine. If the number of volunteers tested is small, the effect that appears is the effect that is considered frequent. Therefore, to see rare side effects, vaccines are being tested in more people. Can reach tens of thousands.
“In this phase, it is usually carried out in several centers, in several countries, then seen in various people, but still in healthy people usually. Then look at its effectiveness, so what are the levels of antibodies and also efficacy, efficacy, whether it can protect the vaccinated person against infection, which must be observed. Usually the length of observation, if the shortest is 6 months. “
If in phase 3 there are no side effects and it’s safe, then the vaccine is said to be safe for use. Apart from being safe, of course it is considered to be nutritious and useful.
These three phases usually take up to 10 years. Vaccines that work well in phase 3 can then be approved by regulators. In Indonesia, the regulator is BPOM. BPOM will also look at all data from pre-clinic to phase 3 clinical trials before deciding whether the vaccine is suitable for distribution.
After the vaccine is allowed to be distributed, research is still continuing into phase 4 clinical trials, which is a survey of the safety and effectiveness of the vaccine continuously.
“Surveys on vaccine safety issues continue to be carried out, even though the vaccine has been allowed to be distributed, can be used by the public, mass use is allowed. But it must be monitored. In case there is something that should be reported regarding its use. “
Reporter Magang: Maria Brigitta Jennifer [gil]
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