FDA says Pfizer seeks EUA for COVID-19 vaccines for 5-11 years old
The Food and Drug Administration (FDA) said Pfizer submitted its application for the emergency use authorization of COVID-19 vaccines for 5 to 11 years old.
"As of now we received an (EUA) application from Pfizer for 5-11 years old. They submitted it last week," FDA Director General Eric Domingo said in a radio interview on Sunday.
"It is being evaluated now by our vaccine experts," he added.
Domingo said the EUA of Pfizer for 5-11 years old may be issued within the year as the government is looking at expanding the pediatric vaccination in 2022.
"So there is a possibility that the EUA may be given before the end of the year," he said.
Domingo said Pfizer's COVID-19 vaccine is being used in other countries.
"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 trials and we will see its safety and efficacy," he said.
"So far, (the result is) good. In fact, the vaccine is given at a lower dose on young children because they are smaller, (age) 5-11 (years old). Good, there was nothing unusual or any signal that would cause worries and fear. I'm quite confident that once they submit all the data, our experts will be satisfied," he added.
Domingo said it will be up to the experts to determine how many doses will be given for children.
"It depends on the appreciation of our experts on their data, but at least one shot," he said.
Domingo said Sinovac had submitted an EUA application for its COVID-19 vaccine for 3 to 17 years old, but experts are requesting for more data.
The use of Pfizer as booster shots for 15 to 17 years old is set to be discussed by the vaccine expert panel within the week. Robina Asido/DMS
