Jakarta, CNN Indonesia –
In the near future Indonesia will soon be rolling out clinical trial phase III Covid-19 vaccine made by Sinovac from China to 1,620 people.
Vaccine clinical trial is the stage of testing a vaccine against humans. This test will be held by Bio Farma in collaboration with Padjadjaran University.
Pandemic & Epidemiologist from Griffith University in Australia, Dicky Budiman explained the stages that took place from the search for volunteers to phase I through III testing.
Dicky said that the conditions for volunteers were healthy and 19-59 years old. Second, living in a city where the research location is carried out so that it is easily monitored. Third, do not have a history of Covid-19 disease.
Fase I
Furthermore, Dicky explained that in phase I, the vaccine will be tested on 100 adults. Phase I test aims to test the safety and dose and stimulation of the immune system.
“The initial stage of vaccine testing is that there are not many direct samples. The vaccine is injected twice with a gap of 4 weeks. Safety monitoring and stimulation of the immune system is carried out closely every three days to seven days,” Dicky said when contacted by CNNIndonesia.com, Monday (27 / 7).
Phase II
Dicky said, if the volunteers turned out sick, then details would be examined to ascertain whether the illness was a symptom of the vaccine or not. If in this phase the vaccine being tested is declared safe it will continue to phase II.
In phase II, vaccine testing is carried out on hundreds of people of various ages. This phase will test the success rate and usually takes three months.
“If immunity in more than 50 percent of volunteers is achieved, the vaccine can be considered effective,” said Dicky.
Phase III
Phase III vaccine testing aims to see the efficacy, effectiveness, and reactions or side effects that arise. Dicky said the potential vaccine was given to thousands of volunteers to determine the efficacy of the vaccine against the Covid-19 virus.
The more volunteers involved, the better, with also variations in age and level of risk.
“The third phase of vaccine testing, a potential vaccine is given to thousands of volunteers to determine the efficacy of vaccines against the corona virus,” said Dicky.
Volunteers will be divided into two, some vaccinated and some injected placebo (not the vaccine to be tested).
During the test period, each volunteer must record every complaint and reaction experienced after the vaccine injection. Phase III testing will take around 180 days (the fastest).
Safety monitoring and stimulation of the immune system is carried out closely every three days to seven days. At the beginning of the week the lag can be every 3 days.
“The level of immunity and reactions that occur in volunteers who have been injected with the vaccine are continuously monitored,” said Dicky.
Dicky explained that the third phase of the test was also closely monitored by institutions such as BPOM and appointed experts. Dicky said if phase III was successful, the vaccine would be submitted for mass use.
Not to forget, Dicky suggested that vaccines remain through five-year evaluations and surveys to ensure vaccines remain effective in warding off mutated viruses.
“If phase III is successful, then the government will submit it for approval so that the vaccine can be used en masse with a five-year survey,” said Dicky.
(jnp / eks)
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