Inaprubahan na ng Food and Drug Administration (FDA) ang paggamit ng bakunang Pfizer-BioNTech COVID-19 sa mga batang may edad 12 hanggang 15, kinumpirma ito ng Department of Health (DOH) nitong Martes, Hunyo 8.
Ito ang sinabi ni DOH Undersecretary Maria Rosario Vergeire nang tanungin kung inaprubahan na ng FDA ang emergency use (EUA) ng bakunang Pfizer-BioNTech.
Noong nakaraang Mayo 26, sinabi ng Direktor ng FDA na si Rolando Enrique Domingo na ang Pfizer ay nagsumite ng aplikasyon para sa isang EUA ng bakuna upang payagan ang paggamit nito sa mga bata na nasa edad 12 hanggang 15 taong gulang.
The Food and Drug Administration (FDA) has approved the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 12 to 15, the Department of Health (DOH) confirmed on Tuesday, June 8.
This was bared by DOH Undersecretary Maria Rosario Vergeire when asked if the FDA already approved the amended emergency use authorization (EUA) of the Pfizer-BioNTech vaccine.
Last May 26, FDA-Director General Rolando Enrique Domingo said that Pfizer has applied for an amendment on its vaccine’s EUA to allow its use on children between 12 to 15 years of age.
“After due consideration, the Food and Drug Administration (FDA) hereby revises the EUA granted to Pfizer-BioNTech COVID-19 Vaccine to reflect requested change in the indication,” batay sa binagong dokumento sa EUA ng bakunang Pfizer-BioNTech na ibinigay ng DOH .
“The Pfizer-BioNTech COVID-19 vaccine shall be administered only by vaccination providers, and used only to prevent COVID-19 in individuals ages 12 and older,” dagdag na niya.
Kahit na naaprubahan na ang bakuna para sa edad na 12 hanggang 15, sinabi ni Vergeire na mananatili pa rin ang gobyerno sa pagbibigay ng priyoridad sa bakuna.