Moderna appeals for EUA to use COVID-19 vaccine for kids — FDA
By Nehmia Elyxa Relano
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| PHOTO: Canadian Inquirer |
The Food and Drug Administration (FDA) Director-General Eric Domingo, on Tuesday, said the American firm Moderna, Inc. has sought emergency use authorization (EUA) to use its COVID-19 vaccine for children aged 12 years and up in the country.
According to Domingo in a weekly Talk to the People briefing, Moderna requested an amendment to its EUA on August 19, 2021.
Currently, the Philippines' FDA is deciding whether or not to approve Moderna's COVID-19 vaccinations for emergency use in teenagers.
Moderna has given clinical data, and FDA experts expect to complete their review of the documents this week or next week.
"Hopefully, within this week or next week makumpleto na ang evaluation nito," Domingo stated during the taped Cabinet briefing.
If approved, Moderna would be the second COVID-19 vaccine cleared by the FDA for use among persons younger than 18.
Furthermore, the FDA authorized the Pfizer-BioNTech vaccine for 12 to 15-year-olds in early June.
Meanwhile, the application submitted by the Chinese vaccine maker Sinovac has yet to be approved by the FDA due to its lack of clinical trials for children.