FDA to amend this week Pfizer EUA allowing its use for those aged 12 to 15 in PHL

(File photo) Food and Drug Administration (FDA) Director General Eric Domingo in a Laging Handa Press briefing on Tuesday, Jan. 19, 2021. (Screenshot of RTVM video/Courtesy PCOO/RTVM)

(Eagle News) – The Food and Drug Administration said that it would issue an amendment to the Emergency Use Authorization (EUA) it has issued to Pfizer vaccines that would allow the doses to be given to those aged 12 to 15 years old.

FDA Director General Undersecretary Eric Domingo said this after the Pfizer applied for an amendment of its EUA so the Pfizer doses could also be given to children in this age group.

“Within the week po we will be issuing an amendment to the emergency use authorization of Pfizer, and we will be able to use it in children, 12 to 15 year olds,” Domingo said.

Pfizer applied for the amendment on May 20 citing that the vaccine is already being administered in the US for those aged 12 to 15.

At present, Pfizer doses can be used for those aged 16 and above in the country.  The FDA issued the EUA for Pfizer on Jan. 14, the first EUA to be issued for a COVID vaccine.

The United States started in mid-May allowing children aged 12-15 to get vaccinated against COVID-19.

On Tuesday, Singapore also authorized the use of the Pfizer-BioNTech Covid vaccine to teenagers aged 12 to 15, which is a first for Asia.

Singapore’s Health Sciences Authority extended the use of the vaccine — currently only approved for individuals aged 16 and above — after reviewing clinical data submitted by the manufacturer.

FDA’s Domingo said that he had received so far “very favorable” recommensations from the country’s vaccine experts on allowing the use of Pfizer for those aged 12 to 15.

Yung atin pong mga experts ay in-evaluate (Our experts are already evaluating this). In fact, early this evening, I already got the recommendations of our experts and [these were] very favorable,” he said.

(Eagle News Service)