FDA okays use of Pfizer COVID-19 vaccine to children 5-11 years old

FILE PHOTO: Children ages 12 to 17 years old from the city of San Juan receive their first dose of Pfizer vaccines on November 3, 2021. INQUIRER PHOTO / NINO JESUS ORBETA

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday granted the emergency use authorization (EUA) of Pfizer’s COVID-19 vaccine for children aged 5 to 11.

“Upon review of technical documents and evaluation of the US (United States) FDA recommendations, our experts have found that the data submitted is sufficient for the EUA approval,” FDA director-general Eric Domingo said during the Laging Handa briefing.

“Nakita naman po natin na (We observed) 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 also pointed out that Pfizer has a 90.7 percent efficacy for the said age group.

He also assured that adverse events observed during the clinical trials are mild.

“‘Yun pong nakitang adverse events du’n sa clinical trial ay very mild lamang po katulad lamang ng ibang bakuna na natatanggap ng ibang bata. So, kaunting siguro po may sinisinat, kaunting pananakit du’n sa area ng injection. Pero wala pong nakitang any unusual or important safety signals para po hindi natin mabigay itong EUA. So, this is being granted today,” Domingo said.

(The adverse events during the clinical trials were very mild like other vaccines that children received. Some experience fever, slight pain in the injection site. But there are no unusual or important safety signals for us not to give this EUA. So, this is being granted today.)

But the FDA official said the COVID-19 vaccine dosage for children will be different from adults. Hence, asking concerned authorities to procure it separately.

“Ito po ay mas mababang dosage at hindi lamang po ‘yun, ‘yung concentration din po nung vaccine ay mas mababa din po kaysa du’n sa ginagamit sa adults ngayon,” he noted.

(The vaccine for children has a lower dosage and concentration compared to what is being administered to adults now.)

“Last week pa po, sinabihan na namin ang ating task force, sina [vaccine czar] Secretary [Carlito] Galvez, at ang Department of Health Secretary Duque na ibang vaccine po itong gagamitin ng 5 to 11 sa mga bata. So, they will have to order and procure these separately,” Domingo further said.

(Last week, we already told our task force, Secretary Carlito Galvez Jr., and Department of Health Secretary Francisco Duque III that the vaccine for children 5 to 11 years old would be different. So, they will have to order and procure these separately.)

Pfizer’s COVID-19 vaccine is only being used in the country for adults and children 12-17 years old before the FDA approved its EUA for children aged 5-11 on Thursday.

KGA