FDA not yet recommending use of Sinovac COVID-19 jab for Filipino children aged 3 to 17

Published August 25, 2021, 2:00 AM

by Analou de Vera


The Food and Drug Administration (FDA) said it is not recommending “at this time” to use the coronavirus disease (COVID-19) vaccine made by China’s Sinovac Biotech for Filipino children aged three to 17.

“At this time, hindi pa po natin iyan marerekomenda na ma-authorize na magamit po sa mga bata. So, for adults pa rin po (At this time, we cannot recommend that it be authorized to be used for children. So, this vaccine is still for adults),” said FDA DIrector-General Rolando Enrique Domingo during President Duterte’s “Talk to the People” on Tuesday night, Aug. 24.

Domingo said that they need more data to support that this vaccine is suitable for children aged 3 to 17.

“Nung tiningnan po ng ating mga vaccine experts, medyo maliit po yung Phase 1 and Phase 2 trial na kung kasama yung mga bata na three years old to 17 years old (When our vaccine experts looked at their Phase 1 and Phase 2 [clinical] trials, the data on children—aged three to 17—-was still relatively small),” he said.

“We advised the company to send us reports kapag po mas marami na po silang clinical trial Phase 3 data on children— so that we can revisit (We advised the company to send us reports when they have more clinical trial Phase 3 data on children—so that we can revisit),” he added.

Last July 6, Sinovac Biotech applied for an amendment to the EUA of its COVID-19 vaccine in order for it to be used on children aged three to 17, Domingo then announced.

Based on Sinovac’s EUA document, it’s vaccine can be used for individuals aged 18 to 59.

The FDA had earlier allowed the use of Pfizer-BioNTech COVID-19 for 12 years old and older.

Related story:

FDA: Sinovac seeks to expand use of its COVID-19 vaccine on children ages 3 to 17