Jakarta: Chairman of the National Commission (Komnas) for the Study & Management of Post-Immunization Associated Events (PP-KIPI) Hindra Irawan Satari confirmed vaccine covid-19 is safe. In fact, the safety of the corona vaccine is maintained until it is injected into humans.
“This immunization safety observation has been carried out since before it was given to humans or at preclinical time,” Hindra said in a virtual discussion with the Ministry of Communication and Information, Jakarta, Thursday, November 19, 2020.
Preclinical testing involves a number of animals to observe vaccine safety. Vaccine side effects are observed in this phase.
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“Judging, there is a disability or not. It will cause death or side effects. If not, then enter phase one which involves a number of volunteers,” Hindra explained.
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In phase two, the trial involved dozens of volunteers. Followed by phase three involving thousands of volunteers. Once all is in place, clinical trial results are recorded and reported to the World Health Organization (WHO).
“Then, it is analyzed, studied, and concluded. After that, it is published in a respected scientific journal and everyone can read it,” he said.
At this stage, the responsible agencies such as the Food and Drug Supervisory Agency (BPOM) are involved in vaccine supervision. The research institutions involved to test this vaccine are also not arbitrary.
Hindra again ensures that vaccines are safe because they have gone through various studies and researches. To date, 1,620 vaccine volunteers covid-19 have not reported the incidence of post-immunization follow-up (AEFI) with severe symptoms.
“So far (the report) has only had heat and pain in the area that was injected. That’s normal,” said Hindra.
(SURE)
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