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DOH: FDA awaiting Pfizer EUA bid on COVID vax for ages 5-11

The Food and Drug Administration is already expecting Pfizer to submit an emergency use authorization (EUA) application for the vaccination of 5 to 11 age group, according to the Department of Health. 

Health Undersecretary Maria Rosario Vergeire said no manufacturer has applied for an EUA for the COVID-19 vaccination of this age group in the country.

“Ang sabi ng Food and Drug Administration, they are expecting submission already from Pfizer kasi sa US FDA naaprubahan na siya (because it was already approved by the US FDA),” Vergeire said in a media briefing.

“Usually daw, apparently, according to FDA, pagka nakakakauha na ng emergency use authority sa US, ang manufacturers ay agad-agad nagsu-sumite sa ibang bansa ng kanilang application,” she added.

(Usually, according to the FDA, once manufacturers get the EUA from the US FDA, they will immediately submit applications to other countries.)

In late October, the US FDA authorized the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years, making it the first COVID-19 shot for young children in the United States.

Vergeire said they will wait for the evaluation and the issuance of an EUA.

“Lagi naman, ano, kapag tayo ay nagbabago ng age group o may idinadagdag na age group doon sa mga pwedeng bakunahan with a specific brand of vaccine, kailangan natin antayin ‘yung emergency use authority,” she said.

(It’s always like this, if we change or add another age group, we need to wait for the EUA.)

As of November 8, the Philippines has vaccinated a total of 230,357 minors. —LBG, GMA News


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