December 13 ------ Vaccine makers Pfizer and BioNTech have already submitted an authorization request to the Philippine Food and Drug Administration (FDA) to clear their coronavirus disease (COVID-19) vaccine for use in children aged five to 11 years old. FDA Director-General Rolando Enrique Domingo said that Pfizer-BioNTech submitted their vaccine data and is currently being reviewed by the country’s Vaccine Experts Panel. “Sa ngayon, meron tayong application galing sa Pfizer for five to 11 years old. Sinubmit nila ito last week. At ito ang ine-evaluate ngayon ng ating vaccine experts,” he said in an interview over radio DZBB on Sunday, Dec. 12.
Domingo said they are expecting to come up with a decision by the end of 2021. “May possibility na siguro by the end of the year mabigyan natin iyan ng EUA [emergency use authorization], kasi ang plano din ata nila Sec. [Carlito] Galvez, kung hindi ako nagkakamali ay mag expand tayo to five to 11 by January next year,” he said. Under the current EUA of Pfizer-BioNTech COVID-19 vaccine, it can be used for individuals 12 years of age and older.
The FDA chief said that this vaccine is already being administered in children five to 11 years old in some Western countries. “Yung Pfizer ginagamit ngayon sa US, Canada, at sa ibang bansa sa Europa for five to 11. Yun din ang maganda, na nagamit na sa ibang bansa at makakakita tayo ng real world data outside of clinical trials (The Pfizer vaccine is now being used in the US, Canada, and other countries in Europe for five to 11 years old. That’s also good because we can see real world data outside of clinical trials),” he said.
Based on the safety and monitoring data of other countries, it showed that this vaccine brand has not led to serious adverse effects among this specific age group, said Domingo. “Maganda naman. In fact lower dose ang ginagamit sa mga bata dahil siyempre mas maliit itong five to 11…Yung kanilang safety data and monitoring right now is good,” he said. “Walang nakikita na anything unusual o mga signal na nakakangamba o nakakatakot. Ako, I’m quite confident na once ma-submit nila lahat ng data ay masa-satisfy ang ating mga eksperto,” he added.
Moderna
Meanwhile, Domingo said that vaccine maker Moderna has yet to submit an application for its vaccine to be used for children aged five to 11. “Sa ngayon wala pa tayong natatanggap na application from Moderna. Hindi pa sila nagbibigay sa atin ng clinical trial data nila on children below 12,” he said. “Talagang hanggang 12 years old pa lang ang sinubmit nila sa atin. Until mag submit sila sa atin, hindi pa natin mabibigyan ng permit yan for use in children below 11 years old,” he added. To note, Pfizer-BioNTech and Moderna are the only vaccines with emergency use authorization for 12 to 17 years old issued by the Philippine FDA so far.
Source: mb.com.ph
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