MANILA (2nd UPDATE) - The Food and Drug Administration has approved the Pfizer COVID-19 vaccine for emergency use of children 5 years old and above, its chief said Thursday.

The FDA earlier granted an EUA for Pfizer-BioNTech's vaccine for use of individuals aged 12 years old and above.

"Upon the review of technical documents and evaluation of the US FDA recommendations, our experts have found the data submitted is sufficient for EUA approval," FDA Director General Eric Domingo said in a virtual public briefing.

"Nakita naman po talaga natin na (we saw that) it is reasonable to believe that the vaccine may be effective to prevent COVID-19 and the benefits of the vaccination outweigh the known potential risks."

Government is eyeing to roll out COVID vaccination for children aged 5 and above as early as January, Domingo added.

"Sa pagkakaalam ko po ito po ay pinaplano ng NTF (National Task Force against COVID-19) at DOH (Department of Health) na gawin as early as January next year, siyempre depende po 'yan kung merong na-order na sila o naka-secure na sila ng supplies ng bakuna para sa mga bata," he said.

(As far as I know the NTF and DOH are planning to do it as early as January next year. Of course it depends if they have ordered or secured vaccine supply for children.)

The FDA last week advised the DOH and vaccine czar Carlito Galvez Jr. that government would have to procure separate vaccines for children, according to Domingo. The dosage that will be given for children is 10 micrograms, lower than those for adults, he said.

"'Yun pong present doses natin ngayon ay pang-adults po 'yun at maaaring gamitin sa 12 to 17 (years old)," he said.

(The doses we currently have are for adults and can be used for 12 to 17 years old.)

The vaccine has an efficacy rate of 90 percent to children aged 5 and above, with "very mild" adverse events, Domingo said.

"Wala pong nakitang any unusual or important safety signals para hindi natin ibigay itong EUA. This EUA is being granted today," he said.

(We did not see any unusual or important safety signals that could serve as reasons not to give this EUA.)

There are some 13.5 million children aged 5 to 11 in the Philippines, the DOH said in a statement. Guidelines for the administration of
COVID-19 vaccines for this age group have yet to be released, it added.

The Philippines has so far fully vaccinated 46.38 million individuals, while 56.72 million have received an initial dose as of Wednesday noon, according to DOH data.

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