FDA still awaiting additional clinical trial data on use of Sinovac vaccine for kids

Published October 6, 2021, 3:09 PM

by Analou de Vera


The Food and Drug Administration (FDA) said that it is still waiting to see more data on the use of the Sinovac coronavirus disease (COVID-19) vaccine on children.

FDA Director General Rolando Enrique Domingo said that they are waiting for the Phase 3 clinical trial data of the Sinovac vaccine.

“Kasi una na silang nagpahiwatig na gusto rin nga nilang mag-apply ng pediatric vaccine… kaya lang iyong data nila from Phase 1 and Phase 2 trials na medyo kakaunti iyong mga bata doon. Kung hindi ako nagkakamali, parang mga 200 lamang (They showed their interest to apply for pediatric vaccine… However, few children were included in the data of their Phase 1 and Phase 2 trials. If I’m not mistaken, it’s only about 200),” said Domingo on Wednesday, Oct. 6.

Once the developers of the Sinovac vaccine give their Phase 3 clinical trial data, it will be reviewed by the country’s vaccine experts, said Domingo.

“Alam natin na may ongoing sila na Phase 3 trial sa mga pediatric age groups, at kapag mayroon na silang data noon ay maaari nilang i-submit sa atin para makita po ng mga experts natin (We know that they have an ongoing Phase 3 trial with pediatric age groups. Once they have the data, then they can submit it to us for our experts to review it),” he said.

In July, Sinovac Biotech applied for an amendment to the emergency use authorization of its COVID-19 vaccine in order for it to be used on children aged three to 17.

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