PHL FDA chief says EUA granted to Pfizer for administration to kids aged 5 to 11; vaccination could start in January next year depending on supplies
(Eagle News) – The Philippines’ Food and Drug Administration (FDA) has approved the use of Pfizer vaccines for children aged 5 to 11 years old in the country.
FDA Director-General Undersecretary Eric Domingo said that they have already approved the emergency use authority (EUA) for the administration of Pfizer vaccine doses to those aged 5 to 11, citing the vaccine’s over 90 percent efficacy.
“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,” Domingo said in a Laging Handa press briefing on Thursday, December 23.
“Mataas din po iyong kaniyang efficacy rate, above 90% sa mga batang 5 to 11 years old and at the same time iyon pong nakita adverse events doon po sa clinical trial ay very mild lamang po,” he said.
So far, the side effects, if any from the Pfizer vaccines, were mild such as slight fever and pain at the injection site.
These were what had been reported so far from among those who got Pfizer doses, including children aged 12 to 17.
“Pero wala pong nakitang any unusual or important safety signals para po hindi natin ibigay itong EUA. So this is being granted today,” the FDA chief said on Thursday, Dec. 23.
Pfizer sought EUA for the administration of the vaccine to kids aged 5 to 11 in November. This was also the vaccine brand that was first approved for those aged 12 to 17 years old.
Domingo said that so far, Pfizer doses have already been administered to children 5 to 11 years old in other countries, including the United States, Canada, and several countries in Europe.
“Upon the review of the technical documents and the evaluation of the US FDA recommendations, our experts have found that data submitted is sufficient for the EUA approval,” Domingo noted.
The FDA had already informed vaccine czar Secretary Carlito Galvez Jr., and Health Secretary Francisco Duque III of the decision granting EUA to Pfizer for young children.
-Procuring vaccines separately for kids aged 5 to 11-
Domingo said that the vaccines to be used for those aged 5 to 11 would still have to be procured separately.
The current Pfizer vaccine doses that the country has have been already reserved or allocated for the adult population, and those aged 12 to 17.
“Actually last week pa po sinabihan na namin ‘no ang ating task force, sila Secretary 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 this separately. Iyon pong mga present doses po natin na nandito ngayon ay pang-adults po iyon at maaaring gamitin sa 12 to 17 pero sa 5 to 11 ibang bakuna po iyong gagamitin,” Domingo explained.
If there could be additional vaccine supplies secured for delivery for those aged 5 to 11, the vaccination of young kids could start as wearly as January next year, according to Domingo.
He said this would be all dependent on the vaccine supplies.
“Ang nalalaman ko po ay ito po ay pinaplano ng NTF at saka po ng DOH na gawin as early as January next year. Pero siyempre po iyan, depende kung nag-order na rin po sila or kung mayroon na silang na-secure, nakabili na sila ng supplies para dito po sa bakuna na pambata at kung ready na pong mag-rollout. Pero ang plano po talaga niyan ay as early as January,” the FDA chief said.
(Eagle News Service)