FDA expects vaccination of children below 12 before year ends

Published November 23, 2021, 2:56 PM

by Dhel Nazario

Pfizer-BioNTech and Sinovac vaccines are expected to be administered to children ages four to 11 as part of the pediatric vaccination program before the end of 2021, the Food and Drug Administration (FDA) said on Tuesday, Nov. 23.

(MANILA BULLETIN FILE PHOTO)

“I would think before the end of the year. I’m pretty sure Pfizer is going to be ready and Sinovac told us that their data is being collated and will be submitted soon. So I believe before the end of the year we’re going to have vaccines for children below 12,” FDA Director-General Eric Domingo said during a palace press briefing.

Domingo stated that Pfizer has already reached out to the FDA and has asked for the list of requirements which they are currently completing. He said that they hope that they will be sending their application for an Emergency Use Authorization (EUA) “very soon”.

“Meron lang kasi difference konti sa formulation ng vaccine for children so it’s going to be, it’s like a new Emergency Use Authorization (EUA) kasi may medyo bagong innovation dun sa product (There is just a slight difference there in the formulation of vaccine for children so it’s going to be like a new EUA because there is a new innovation for the product),” he explained.

Domingo is also hoping to get the data soon from Sinovac. He mentioned that they are waiting for them to submit their data for children below 18 years old to be able to give it to the country’s vaccine experts.

Meanwhile, for children 12 to 17 years old, Domingo shared that there are around 500,000 pediatric vaccinations conducted mostly with Pfizer and some Moderna vaccines. He also said that the adverse event monitoring is very low and is at less than one percent.

 
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