Moderna asks for FDA’s approval to clear its COVID-19 vaccine for 12 years old and up

Published August 25, 2021, 6:37 AM

by Analou de Vera

This file photo taken on November 18, 2020 shows a syringe and a bottle reading “Vaccine Covid-19” next to the Moderna biotech company logo. (Photo by JOEL SAGET / AFP / MANILA BULLETIN)

The Food and Drug Administration (FDA) said that it is currently studying if it will approve or not the emergency use of the coronavirus disease (COVID-19) vaccine made by American pharmaceutical firm Moderna for children.

FDA Director-General Rolando Enrique Domingo said that Moderna has submitted an application to amend its COVID-19 vaccine’s emergency use authorization (EUA) to also approve its use for “12 years old and above.” Currently, the Moderna vaccine is being used in 18 years old and older.

“Nagpadala na rin sila ng kanilang datos ng clinical trials at ito ay inaaral ngayon ng ating mga experts (They have also sent their clinical trial data and it is now being studied by our experts),” said Domingo on Tuesday night, Aug. 24, during President Duterte’s “Talk to the People.”

Domingo said that the evaluation is set to finish by next week or earlier.

“May mga kaunting katanungan po doon sa developer ng vaccine and hopefully within this week or next week, makumpleto natin yung evaluation (There are a few questions for the vaccine developer and hopefully within this week or next week, we will complete the evaluation),” he said.

“[Ito ay] para tingnan natin kung maari din siyang gamitin sa mga bata pagdating ng panahon na yung vaccination program natin ay aabot na doon sa mga pediatric or at least adolescent age group ([This is] so we can see if it can also be used on children— when the time comes that our vaccination program will already cover the pediatric or at least the adolescent age group),” he added.

If Moderna gets the nod of FDA, it would be the second COVID-19 vaccine cleared for use among children. To note, the Pfizer-BioNTech vaccine was approved for use in individuals ages 12 and above last June 8.

However, the country’s COVID-19 vaccination program has yet to cover children due to limited vaccine supply. Currently, the government is vaccinating the adult priority sectors such as healthcare workers, senior citizens, persons with comorbidities, essential workers, among others—- since they are more vulnerable to COVID-19.

Two pediatric organizations, the Pediatric Society of the Philippines (PPS) and the Pediatric Infectious Disease Society of the Philippines (PIDSP), urged eligible adults last Aug. 10 to get themselves vaccinated to protect children against COVID-19.

“(We) recommend that the older and more vulnerable adult age groups should still be given precedence in the vaccination roll-out,” they then said.

“Once a sufficient percentage has been vaccinated in the priority adult groups, children 12 years-old and above may be considered for vaccination, with priority given to those who live in areas with high transmission and those with comorbidities,” they added.