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

By Ma. Teresa Montemayor/ Philippine News Agency

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 applications 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 in the government’s vaccination program where they are given Pfizer and Moderna jabs.

Meanwhile, Pfizer has applied for an EUA of its vaccine to be used as a 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. (PNA) -rir

 

Popular

PBBM inaugurates P1B irrigation project in Leyte

By Sarwell Meniano | Philippine News Agency President Ferdinand R. Marcos led the inauguration of the P1.1 billion Hibulangan Small Reservoir Irrigation Project (SRIP) in...

PBBM brings aid to Eastern Visayas, advances whole-of-gov’t approach

By Ruth Abbey Gita-Carlos | Philippine News Agency President Ferdinand R. Marcos Jr. on Thursday led the rollout of government assistance and development initiatives in...

PBBM: Stronger cooperation with LGUs key to reducing crime

By Ruth Abbey Gita-Carlos | Philippine News Agency President Ferdinand R. Marcos Jr. has emphasized the importance of stronger cooperation between the national and local...

PBBM summons French, Czech envoys over Zaldy Co’s status

By Brian Campued President Ferdinand R. Marcos Jr. on Wednesday expressed disappointment over the release of fugitive former lawmaker Zaldy Co in the Czech Republic. According...