It remains to be seen scientific data about clinical trials
Jakarta (ANTARA) – Head of the Applied Genetic Engineering Laboratory of the Indonesian Institute of Sciences (LIPI) Wien Kusharyoto said scientific data was needed to ensure the safety and efficacy of the Sinovac vaccine in children.
“So far there has only been a ‘press release’ regarding the safety of the vaccine from Sinovac in children up to the age of three years. Scientific data must still be shown about this clinical trial to demonstrate the safety and ability of the vaccine to trigger an immune response,” Wien said when contacted by ANTARA. , Jakarta, Monday.
Wien said that if the data shown were indeed qualified, then the vaccine could be further tested in a phase 3 clinical trial by involving more pediatric volunteers to ensure the vaccine’s effectiveness in children.
The researcher from the LIPI Biotechnology Research Center said that the clinical trials that have been carried out have involved several hundred children, so that they have fulfilled the requirements as a combination of stage 1 and 2 clinical trials.
Until now, there is no COVID-19 vaccine that can be used for children.
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Previously, the spokesperson for COVID-19 vaccination from the Food and Drug Administration (BPOM), Lucia Rizki Andalusia, stated that there was no published information regarding the clinical trial results of the Sinovac COVID-19 vaccine for the 3 to 17 year age group.
“Currently, clinical trials in phase I / II involving volunteers with the age group of 3 to 17 years (children) are taking place in China, the country of origin of the Sinovac Vaccine producer,” he said when contacted by telephone, Thursday afternoon (25/3). .
After the phase 1 and 2 clinical trials are completed, they will proceed to phase 3 clinical trials to meet the requirements of the World Health Organization (WHO).
According to Lucia, WHO has provided a number of requirements before vaccine products obtain permission for emergency use or EUA.
“WHO has a requirement for a new vaccine to get permission for emergency use or EUA. So we are still waiting for the results,” he said.
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Reporter: Martha Herlinawati Simanjuntak
Editor: Zita Meirina
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