FDA OKs emergency use of Pfizer for 5- to 11-year-olds

MANILA – Food and Drug Administration (FDA) Director General Eric Domingo said Thursday the government has issued an emergency use authorization (EUA) for the Pfizer-BioNTech vaccine against the coronavirus disease 2019 (Covid-19) to be used among children aged five years to 11 years.

In a televised public briefing, Domingo noted that the EUA “is being granted today.”

“Nakita naman po talaga natin na (We have really seen 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 said.

He added that the jab has a high efficacy rate – above 90 percent – and its adverse events are very mild with no unusual or important safety signals, as shown in the clinical trial.

The Pfizer Covid-19 vaccine comes in different brands – Tozinameran and Comirnaty – depending on its country of origin.

The jab for younger children has a lower dosage compared to the one for adults.

“Iyong concentration din po noong vaccine ay mas mababa din po, kaysa doon sa ginagamit sa adults ngayon. So, iyon pong bakuna na ginagamit sa mga adults at saka sa 12 to 17, 12 pataas, ay hindi po iyon ang gagamitin sa mga bata (Its concentration is also lower compared to the one being used for adults. The vaccine used by adults and 12- to 17-year-olds will not be used for younger children),” Domingo said.

He noted that because the Pfizer doses in the country are for adults, the FDA informed the Department of Health and the National Task Force Against Covid-19 to procure separate Pfizer jabs for children aged five years to 11 years.

The government has yet to schedule the vaccination of children aged five years to 11 years against Covid-19.

The inoculation of children aged 12 years to 17 years began in late October while the administration of booster shots for fully vaccinated adults began first week of December.