The Philippine Food and Drug Administration (FDA) reported on Tuesday (Aug. 24) that the American pharmaceutical company Moderna applied to amend its emergency use authorization (EUA) to include the COVID-19 vaccine’s use for ages 12 years old and above.
In President Rodrigo Roa Duterte’s public address, FDA Director-General Eric Domingo said the country’s vaccine experts are currently reviewing the submitted clinical trials by Moderna.
“Iyon naman pong Moderna na binigyan po natin ng EUA, nito pong nakalipas na Biyernes, August 19, nag-apply na rin po sila to amend ‘yung kanila pong EUA para masama rin po ang mga adolescents – children 12 years old and above. So nagpadala na rin po sila ng kanilang datos ng clinical trials at ito po ‘yung inaaral ngayon ng ating mga expert,” he said.
Domingo said the vaccine experts have also sent their questions to Moderna and that their evaluation is expected to be complete within this week or next.
“May mga kaunting katanungan po doon sa developer ng vaccine, and hopefully within this week or next week makumpleto po natin ang evaluation nito. Para po tingnan natin kung maaari rin po siyang gamitin sa mga bata, pagdating po ng panahon na ‘yung vaccination program natin ay aabot na po doon sa mga pediatric or at least sa adolescent age group,” he said,
Meanwhile, the FDA denied Sinovac’s application for its vaccine to be used on children over its lack of clinical trials involving that particular age group.
“Pero ‘yun pong kanilang petition na ma-include po ‘yung children ay hindi pa po natin gina-grant at this time, kasi noong tiningnan po ng ating mga vaccine experts, medyo maliit po ‘yung Phase I and Phase II trial na kung kasama ‘yung mga bata na three years old to 17 years old. And we advised the company to send us reports kapag po mas marami na po silang clinical trial Phase III data on children so that we can revisit,” Domingo said.
(PTV News)/NGS- jlo
