FDA WAITS FOR DATA ON USE OF SINOVAC JABS ON KIDS
THE FOOD and Drug Administration of the Philippines on Wednesday said that it is waiting for additional data from Sinovac on the use of its Covid19 vaccine on children.
“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,” FDA Director General Eric Domingo said.
Data on its Phase 3 clinical trial will be reviewed by vaccine experts once these are submitted, Domingo said.
“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,” he said.
Last July, Sinovac submitted a request to amend its emergency use authorization to include children as recipients.
Although the clinical trial results in China showed that Sinovac’s Covid19 vaccine is safe, Philippine health officials still seek to hold local data.
If approved, the Sinovac vaccine will be the third allowed for children in the country.
The FDA has allowed the emergency use of Pfizer’s and Moderna’s vaccines for minors aged 12 to 17.