PH FDA welcomes latest development in Pfizer-BioNTech's COVID-19 vaccine

Published September 22, 2021, 2:28 PM

by Analou de Vera

In this file photo a healthcare worker fills a syringe with Pfizer COVID-19 vaccine at a community vaccination event in Los Angeles, California, August 11, 2021. (Robyn Beck / AFP)

The country’s Food and Drug Administration (FDA) has welcomed the latest development in the coronavirus disease (COVID-19) vaccine developed by Pfizer and BioNTech—as they announced that their vaccine works in children aged five to 11 years old.

“This is very encouraging kasi mga bagong pag aaral po ito (because these are new studies),” said FDA Director-General Rolando Enrique Domingo on Wednesday, Sept. 22.

In a joint statement on Monday, Sept. 20, the vaccine makers said that “in participants five to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses.”

Pfizer and BioNTech said that they are planning to submit their vaccine data to the US FDA, European Medicines Agency (EMA) and “other regulators as soon as possible.”

In the Philippines, the FDA approved the emergency use of Pfizer-BioNTech vaccine for people aged 12 and above.

“Tingin natin pag nakakuha sila ng EUA for 5 to 12 sa US FDA, mag aapply din sila dito at ipapakita din nila sa atin yung kanilang (We believed that when they get an EUA for those aged five to 12 years old from the US FDA, they will also apply here and they will also show to us their) data which we will ask our expert to look into,” said Domingo.

“Pag nakita naman natin na maganda yung resulta nito, then basta po yung safety profile ay nandyan at yung efficacy ay maganda (When we see that the results are good, then as long as the safety profile is there and the efficacy is good) then, it will have a good chance also of being used in our (country),” he added.

 
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