Pfizer seeking authorization for use of COVID-19 on children: FDA chief

Mico Abarro, ABS-CBN News

Posted at Dec 13 2021 12:54 PM | Updated as of Dec 14 2021 01:43 PM

MANILA - The Philippine Food and Drug Administration said on Monday US drugmaker Pfizer is seeking to amend the Emergency Use Authorization of its COVID-19 vaccine so it could be used on children aged 5 to 11 years old.

At a public briefing, FDA Director-General Eric Domingo said Pfizer filed an application on December 8, 2021. This had already been forwarded to vaccine experts for evaluation. 

He added, the mRNA vaccine was more than 90 percent effective in protecting children against COVID-19. If approved for use on kids, it would be administered in smaller amounts compared with a different formulation. 

"Dahil s'yempre pag bata, mas maliit 'yung amounts na kailangan. 'Yung preparation nag-iiba din pati 'yung concentration ng preparation," he said. 

"Iba po 'yung concentration per ML na gagawin dun sa mga bata, at iba rin po 'yung amount na i-inject sa mga batang maliliit."

(Of course with children, smaller amounts will be needed. The preparation also changes, as well as the concentration of the preparation. For children, the concentration per milliliter is different, as well as the amount that will be injected.) 

Citing clinical trial data, Domingo said the vaccine had no unusual or severe adverse effects on children. A majority of side-effects observed were mild. 

"Ang primary concern po natin lalo na as children get younger and smaller is 'yung safety before the efficacy," he said. 

"So ito po, titignan natin ito during the evaluation, and of course pagka-sakali naman na i-roll out natin, continuous talaga ang monitoring." 

(Our primary concern here is safety, especially as we use the vaccine on smaller and younger children. So we will keep up observation during the evaluation, and of course monitoring will still be continuous once we roll this out.) 

Last week, Australia authorized the use of Pfizer's jab on children aged 5 to 11 years old. Canberra is expected to roll out the vaccine for the age group by January 22nd. 

As for Chinese biotechnology firm Sinovac's own request for pediatric use of its COVID-19 vaccine, Domingo said vaccine experts are still waiting for the company to provide more clinical trial data. Sinovac sought approval for the use of its jab on children aged 3 to 17 years old.