MANILA, Philippines — The Food and Drug Administration (FDA) is expecting Pfizer Inc and BioNTech SE to apply for an amendment to its existing emergency use authorization—by allowing the use of its vaccine for children aged five to 11—within the month.
FDA Director-General Eric Domingo made the remark after the United States authorized the Pfizer COVID vaccine for children aged five to 11 in their country.
“Dun sa huling experience natin sa kanila sa Pfizer, usually pag nakakuha sila ng approval o authorization sa US FDA, after mga two to three weeks naga-apply na rin sila dito sa atin ng amendment at sinusumite nila sa atin yung data,” Domingo said during the Laging Handa briefing.
“Ang aking expectation is probably within this month of November ay maga-apply din po for amendment ang Pfizer to include children 5 to [11] and we will be waiting for that application,” he added.
According to Domingo, the interim results of the Pfizer vaccine for the said age group have been “good.”
“’Yung safety niya at efficacy profile sa age 5-11 ay maganda kaya napayagan na ng EUA sa America. Kaka-rollout lang nito kaya inaabangan din natin yung real world data na lalabas probably by next week,” Domingo said.