FDA: Pfizer submitted EUA application for COVID-19 vaccine for 5-11 years old

Pfizer submitted last week an application for the emergency use authorization (EUA) of its COVID-19 vaccine for children 5-11 years old, the Food and Drug Administration (FDA) said on Sunday.

"Sa ngayon meron tayong application galing sa Pfizer for 5-11 years old. Sinubmit nila ito last week," FDA Director General Eric Domingo said in an interview on Super Radyo dzBB.

(As of now we received an [EUA] application from Pfizer for 5-11 years old. They submitted it last week.)

"Ito ang ine-evaluate ngayon ng ating vaccine experts," he said.

(This is being evaluated now by our vaccine experts.)

"So may possibility na baka mabigyan ng EUA before the end of the year," Domingo said.

(So there is a possibility that the EUA may be given before the end of the year.)

The government is eyeing to expand the pediatric vaccination against COVID-19 to children aged 5 to 11 years old by January 2022.

The FDA chief said Moderna has not yet applied for an EUA for its COVID-19 vaccine to be used on children aged 5 to 11 years old.

"Sa ngayon wala pa tayong natatanggap na application from Moderna. Hindi pa sila nagbibigay ng clinical trial data nila on children below 12," he said.

(As of now we haven't received an [EUA] application yet from Moderna. They have yet to give clinical trial data on children below 12 [years old].)

"Hanggang 12 years old pa lang ang sinubmit nila sa atin. Hindi pa natin mabibigyan ng permit 'yan for use in children below 11 years old," Domingo said.

(The clinical trial data they submitted is only on children from 12 years old and up. We cannot give them yet a permit for the use of the vaccine on children below 11 years old.)

Pfizer's COVID-19 vaccine has already been approved for use on children aged 5 to 11 years old in the US, Canada, Europe, and Australia.

"'Yun ang maganda, na nagagamit sa ibang bansa, at makakakita tayo ng real world data outside clinical trial at nakita natin ang safety at efficacy niya," Domingo said.

(That's the good thing about it, that it is already being used in other countries. We will be able to see real world data outside clinical trial and we will see its safety and efficacy.)

So far, safety and monitoring data abroad showed that the Pfizer COVID-19 vaccine has not led to serious adverse side effects among young children, Domingo said.

"Maganda naman. In fact lower dose ang ginagamit sa mga bata dahil siyempre mas maliit 5-11 [years old]... Good, walang nakikita na anything unusual o signal na nakakangamba o nakakatakot. I'm quite confident na once ma-submit nila ang data, masa-satisfy ang mga experts," he said.

(So far, good [results]. In fact, the vaccine is given at a lower dose on young children because they are smaller, 5-11 [years old]. Good, there was nothing unusual or any signal that would cause fear. I'm quite confident that once they submit all data, our experts will be satisfied.)

Last month, Domingo said the FDA is eyeing a different formulation and a lower dosage of the Pfizer vaccine for the vaccination of minors aged 5 to 11 against COVID-19.

Domingo on Sunday said experts will determine if the vaccine will be given in one dose or two doses on the young children.

"Depende sa appreciation ng experts sa data nila, pero at least one shot," he said.

(It depends on the appreciation of our experts on their data, but at least one shot.)

Meanwhile, Sinovac earlier submitted an application for EUA for their vaccine to be used on children aged 3 to 17 years old, but experts asked for more data, Domingo said.

As for the administration of Pfizer COVID-19 booster shots for teens aged 16-17 years old, Domingo said this will be discussed by the vaccine expert panel this week.

Last week, the US FDA expanded the authorization of the Pfizer-BioNTech COVID-19 booster to include 16- and 17-year-olds. —KG, GMA News