FDA: Pfizer-BioNTech's application for emergency use of COVID-19 vaccine for minors aged 5-11 expected this month

Published November 5, 2021, 5:54 PM

by Analou de Vera

The Food and Drug Administration (FDA) said it is expecting that vaccine makers Pfizer and BioNTech will submit this November their application to authorize emergency use of their COVID-19 vaccine for children aged five to 11.

(MANILA BULLETIN FILE)

“Ang aking expectation is probably within this month of November ay mag-a-apply din po ng amendment sa EUA ang Pfizer to include children five to (11 years old) [My expectation is that probably within this month of November, Pfizer will also apply for an amendment to their EUA to include children five to (11 years old)],” said FDA Director General Rolando Enrique Domingo in a public briefing on Friday, Nov. 5.

In the Philippines, this vaccine is being used for 12 years old and above. The United States’ FDA has already approved the use of the COVID-19 vaccine jointly developed by Pfizer and BioNTech for children five to 11 years old.

“Iyong kanilang interim results are good, iyong safety niya at saka iyong efficacy profile sa age five to eleven ay maganda kaya rin napayagan na po ng EUA [emergency use authorization] sa Amerika (Their interim results are good, the safety and efficacy profile for age five to eleven are good that is why they were able to secure an EUA in America),” said Domingo.

“Kaka-rollout pa lamang nito kaya inaabangan din nga natin iyong Real World Data na lalabas probably by next week (It has just been rolled out so we are also looking forward to the Real World Data that will come out probably by next week),” he added.

Novavax

Domingo also said that they are currently studying the data of the COVID-19 vaccine developed by American biotechnology company Novavax.

“Pinadala na rin sa amin kahapon ng Novavax iyong nakuha nilang EUA from Indonesia at ito iyong sinusuri at inaaral namin ngayon (Novavax also sent us yesterday the EUA they got from Indonesia and this is what we are reviewing now),” he said.

“Of course, we will be taking this into consideration at ang sabi nila malapit na rin yatang makuha iyong EUA nila from India. So, aaralin po natin lahat ito at makita kung sapat na para po makapagbigay din tayo ng EUA dito sa Pilipinas (Of course, we will be taking this into consideration—and they also said they will soon get their EUA from India. So, we will study all these and see if it is enough so that we can also provide an EUA here in the Philippines),” he added.

To note, the FDA has already approved the emergency use of the following vaccines in the country: Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, Janssen, Covaxin, Moderna, and Sinopharm.

 
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