The Philippine Food and Drug Administration (FDA) has approved the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine for emergency use among children five to 11 years old.
“Upon the review of the technical documents and evaluation of the US FDA recommendations, our experts have found that data submitted is sufficient for the EUA approval,” said FDA Director-General Rolando Enrique Domingo on Thursday, Dec. 23.
“Nakita naman talaga natin na (We have found that) it is reasonable to believe that the vaccine may be effective to prevent COVID-19 and the benefits of vaccination outweigh the known and potential risks,” he added.
Domingo said that the vaccine makers submitted their EUA application for children ages 5 to 11 last month.
“Ito pong bakuna na ito ay ginagamit na po sa mga bata sa maraming bansa katulad sa US, Europa, at saka sa Canada (This vaccine is already being used in children in many countries such as the US, Europe, and in Canada),” he said.
During the clinical trials abroad, Domingo noted that no serious side effects were noted among the children who received the said vaccine. The normal side effects would be pain in the injection site or slight fever which are often observed after any vaccination, he added.
“Mataas din po ang kanyang efficacy rate---above 90 percent sa mga batang five to 11 years old (Its efficacy rate is also high --- above 90 percent in children five to 11 years old),” said Domingo.
“Wala pong nakitang any unusual or important safety signals para hindi natin ibigay itong EUA (We haven't seen any unusual or important safety signals),” he added.
Different from Pfizer-BioNTech vaccine used in 12 yrs and up
The FDA chief said this vaccine is different from the one being used for individuals 12 years old and above.
“Hindi po siya kapareho nung dosage na binibigay sa adult. Ito po ay mas mababang dosage at hindi lang iyon, yung concentration ng vaccine ay mas mababa din po kesa doon sa ginagamit sa adults ngayon (It is not the same with regards to the dosage given to adults. It has a lower dosage and not only that, the concentration of the vaccine is also lower than what is being administered in adults),” said Domingo.
“Yung present doses natin na nandito ngayon ay pang adult iyon at maaring gamitin sa 12 to 17. Pero sa five to 11 ibang bakuna po ang gagamitin (The present doses we have here now are for adults and can be used in 12 to 17. But for the five to 11 years old---- another vaccine will be used),” he added.
Domingo said he already coordinated with the National Task Force (NTF) Against COVID-19 Chief Implementer Carlito Galvez and Department of Health Secretary Francisco Duque III for the procurement of this vaccine specific for the said age group.
“Knowing this, actually last week pa, sinabihan na namin ang ating Task Force--sila Secretary Galvez at ang Department of Health— Secretary Duque na ibang vaccine po itong gagamitin sa five to 11 na mga bata (actually last week, we already talked with our Task Force-----Secretary Galvez and the Department of Health— Secretary Duque that another vaccine will be used for children ages five to 11) so they will have to order and procure this separately,” he said.