Metro Manila (CNN Philippines, December 13) — The maker of China’s Sinovac needs to submit updated data for its application for emergency use authorization of its COVID-19 vaccine for children between three and 11 years old, a government official said Monday.
“May hinihingi pang clinical trial data, masyadong maliit ang sample size na kanilang sinubmit,” Food and Drug Administration Chief Eric Domingo said..
“Kapag nakapag-submit ng updated data, ito ay rerebisahin uli ng ating experts para makita kung maaari na siyang payagan,” he added.
[Translation: We have asked for more clinical trial data (because) the sample size they submitted is too small. Once they have submitted the updated data, it will be reviewed again by our experts to see if it can be allowed.]
In July, the Chinese company applied for the amendment of its emergency use authorization to expand the coverage of CoronaVac to children three to 17 years old.
The vaccine is currently for people aged 18-59.
The Chinese embassy in Manila reported earlier that CoronaVac is “at least 98.9 percent effective in producing antibodies, a higher efficacy than in population over 18 years old.”
Meanwhile, the FDA on Sunday said Pfizer submitted an EUA application of its vaccine for children five to 11 years old.
READ: Pfizer submits EUA application for COVID-19 vaccine for 5-11 age group — FDA
Domingo said Pfizer’s emergency application may receive approval before the end of this month.
