Safety is priority over efficacy in COVID vaccine for children — FDA

“Ang primary concern po natin, lalo na the children get younger and smaller, is ‘yung safety. Before the efficacy, ‘yun po munang safety ang tinitignan ng atin pong mga eksperto diyan bago natin payagan,” Domingo said during the Laging Handa briefing, referring to Pfizer’s application for emergency use authorization (EUA) of its COVID-19 vaccine for children aged five to 11.

(Our primary concern, especially with the children getting younger and smaller, is safety. Before the efficacy, our experts are looking into safety first.)

“So far, ‘yung clinical trial data, wala naman pong nakikita na very unusual or tinatawag nating signals of very severe na mga adverse events kundi karamihan ng nakita rin sa mga trials ay mga mild katulad din po ng mga naramdaman sa ibang mga bakuna na ibinibigay sa mga bata,” he added.

(So far, clinical trial data shows that we do not have very unusual or what we call signals of very severe adverse events. Most of those observed during trials are mild,  similar to those observed in other vaccines for children.)

Should the Pfizer vaccine be approved for children below 12 years old, Domingo assured that the government will continue to monitor the minors who received a vaccine.

“Ito po, titingnan natin during the evaluation and of course, ‘pag sakali naman na i-roll out natin, continuous din po talaga ang monitoring. Dahil under EUA, talagang kasama po nu’n, maigting na pagbabantay to make sure lamang na kung mayroong mga unusual tayo na nakikita ay nahuhuli po natin agad,” he assured.

(We will see during the evaluation and of course, should we roll out the vaccines, we will continuously monitor them. Because under their EUA, strict monitoring is included to make sure that if there is something unusual, the same could be promptly addressed.)

Citing data, Domingo said that Pfizer vaccine has a 90.7 percent efficacy rate for children in the five to 11 age bracket.

Currently, Pfizer’s COVID-19 vaccine could be administered to minors aged 12 and above.

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