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DOST expert panel approves clinical trial on use of Sinovac vaccine on children; FDA to issue 'final approval'

Published Aug 16, 2021 01:39 pm

The Department of Science and Technology’s (DOST) Vaccine Expert Panel (VEP) has recommended the approval of the Sinovac’s clinical trial on the use of its coronavirus disease (COVID-19) vaccine for children.

(NOEL CELIS / AFP / MANILA BULLETIN)

VEP head Dr. Nina Gloriani said the panel nodded to the application of China’s vaccine maker Sinovac to conduct clinical trials for children aged three to 17.

“Actually , ang Sinovac ay nag-apply for clinical trials sa children three years to 17 years old. Actually narekomenda na natin ang approval ng clinical trial na yun sa children sa FDA, ongoing po ang evaluation sa FDA ngayon for final approval (Actually, Sinovac applied for clinical trials for children 3 years to 17 years old. Actually we have already recommended the approval of that clinical trial for children to the FDA, the evaluation is ongoing with the FDA now for final approval),” she said during the Laging Handa public briefing on Monday, Aug. 16.

China had approved the use of the Sinovac vaccine or CoronaVac for children as young as three years old.

Currently, the Sinovac vaccine is used for 18 to 59 years old in the country.

"Gusto natin ng local data. Although sa China maganda naman ang data nila in terms of safety at yung immunogenicity, yung antibody responses ng mga bata mas mataas kaysa dun sa may edad (We want local data. Although in China their data is good in terms of safety and immunogenicity, the antibody responses of children are higher than those of adults),” Gloriani said.

“We expect that talagang ganun po yun, but we want local data bago natin sana payagan ang paggamit o pag-deploy widely (We expect that this is really the case, but we want local data before we allow it to be used or deployed widely),” she added.

In July this year, Sinovac applied for an amendment to the emergency use authorization (EUA) of its COVID-19 jab to allow its use on children aged three to 17.

The FDA announced in June that it has authorized the use of the Pfizer-BioNTech vaccine for children aged 12 to 17.

Related Tags

sinovac clinical trial PH CLINICAL TRIAL on use of sinovac vaccine on children Food and Drug Administration FDA Vaccine expert panel DOST VEP
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