FDA amends EUA of Moderna’s anti-COVID jab to allow its use for kids age 6-11

FILE PHOTO: A healthcare worker prepares a syringe with the Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the COVID-19 pandemic in Manhattan in New York City, New York, U.S., January 29, 2021. REUTERS/Mike Segar

MANILA, Philippines — The Food and Drug Administration (FDA) has modified the emergency use authorization (EUA) it issued to the anti-coronavirus vaccine developed by Moderna to allow its administration to children aged 6-11.

This was according to the Department of Health (DOH), which nevertheless said it would first wait for the go signal from the World Health Organization (WHO) before it rolls out the Moderna shots for the said age group.

Health Promotion and Communication Service Director Dr. Beverly Ho announced in a briefing Tuesday that the FDA amended the EUA of Moderna vaccine last May 20.

Ho also noted that in order to launch any COVID-19 vaccines, there should always be a new or amended EUA from FDA and a positive recommendation from the DOH’s Health Technology Assessment Council (HTAC), which will base its decision on either completed Phase 3 and 4 trials, as well as findings and recommendation from the WHO.

“We all await the WHO recommendation on Moderna use for ages 6-11,” said Ho in her presentation during an online briefing.

“This will then guide the Philippine HTAC in its independent evaluation. Should it find evidence to support a positive recommendation, the DOH [National Vaccines Operation Center] will then roll out,” she added.

To recall, the FDA first approved the EUA of the Pfizer-made COVID-19 vaccine for children 5 to 11 years old.

Meanwhile, the DOH reported that more than 69.3 million Filipinos have been fully vaccinated against COVID-19 as of May 30.

Of the total number, 2.7 million were children aged 5 to 11 and 9.4 million were minors below 18 years old.

KGA