FDA awaiting EUA application of Covid-19 vax for ages 5-11

MANILA – No Covid-19 vaccine manufacturer has applied for emergency use authorization (EUA) for safe administration of their jabs to children ages 5 to 11 years old, a health official said Friday.

“Ang sabi po ng FDA [Food and Drug Administration] they are expecting submission already from Pfizer kasi dun sa US FDA naaprubahan na siya (The FDA said they are expecting submission already from Pfizer since the US FDA has granted it with an EUA),” Health Undersecretary Maria Rosario Vergeire said during an online media briefing.

Vergeire noted that vaccine manufacturers usually submit EUA application to different countries once they have secured one from the US FDA.

“We’ll wait for their application, then, the evaluation, then, the issuance of EUA from the FDA,” she said.

To date, only children aged 12 to 17 years old are included the government’s vaccination program where they are given Pfizer and Moderna jabs.

Meantime, Pfizer has applied for an EUA of its vaccine to be used as booster shot or third dose for the healthcare workers and persons with comorbidities.

AstraZeneca, Sinovac and Gamaleya Research Institute have also applied for the same EUA.

Vergeire said the FDA and the vaccine experts panel are completing the documents for the evaluation.

“We’re just wanting to wait for the complete SAGE [Strategic Advisory Group of Experts on Immunization] recommendation, which is the last piece of evidence we need, so, we can give appropriate recommendations,” she added.