A candidate vaccine's safety is tested from the early stages of research — from the phase of animal testing to clinical testing on humans, the commission's head, Prof. Dr. Indra Irawan Satari, said at an online discussion here on Thursday,
"Clinical testing begins with the pre-clinical phase [which progresses] to [tests on] animals to determine [a vaccine’s] safety. If the [tests] on animals do not cause a defect, or death, or other side effects, then we can continue to the first phase of clinical testing," Satari explained.
A vaccine’s safety and efficacy is assessed in the first, second, and third phase of clinical trials, he averred.
The first phase of clinical testing involves several volunteers, while the second involves some hundreds of participants, he said.
The third phase of clinical studies involve thousands of volunteers from various countries, he added.
Furthermore, before a vaccine candidate is cleared for use, the National Agency of Drug and Food Control (BPOM) will evaluate the results of the clinical trials to determine the safety and efficacy of the vaccine, he pointed out.
BPOM will then issue emergency-use authorization (EUA) so the vaccine can be used immediately, he added.
"The fourth phase is post marketing surveillance, and this will be reported to the KIPI for post-immunization monitoring," he said and urged the public to not worry about COVID-19 vaccine safety.
"Vaccine safety will be the main focus during production, immunization, and post-immunization monitoring. Any post-immunization accidents must be reported," he added. (INE)
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Translator: Aditya Ramadhan, Sri Haryati
Editor: Suharto
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