Moderna’s Covid-19 vaccine Spikevax was recently approved by the Food and Drug Administration (FDA) to be used for children six to 11 years old in the country.

Recently, the FDA amended the emergency use authorization (EUA) filed by Zuellig Pharma Corporation, through its commercialization arm, ZP Therapeutics.

“After due consideration, the Food and Drug Administration revises the EUA of the

COVID-19 Vaccine Moderna to reflect the requested amendments,” the FDA said in its EUA document.

According to the FDA, it has taken into account “similar regulatory actions of internationally recognized National Regulatory Authorities (NRA) of Canada, European Economic Area (30 member states), Australia, and other countries such as Peru and Vietnam.”

This is the sixth amendment granted by the FDA to the EUA for the Covid-19 vaccine of Moderna. It was approved by the FDA last May 20.

Before rolling it out, the Department of Health (DOH) said it is still evaluating the evidence behind giving the Moderna vaccine for kids six to 11 years old through the Health Technology Assessment Council (HTAC).

“Matapos ang announcement ng FDA sa kanilang pag-approve ng Moderna, hinihintay naman natin ang masusing pag-aaral ng Health Technology Assessment Council para tuluyan na po itong magamit para batang anim hanggang 11 taong gulang (After the FDA's announcement of their approval of Moderna, we are awaiting a thorough study by the Health Technology Assessment Council so that it can be used for children six to 11 years old),” DOH’s Dr. Beverly Ho said during a press briefing on Tuesday, May 31.

The health department noted that they are still waiting for World Health Organization’s (WHO’s) recommendation on Moderna use for children six to 11 years old.

The recommendation of the WHO will then be the guide of the HTAC in its independent evaluation, the DOH said.

“Should it find evidence to support a positive recommendation, the DOH NVOC (National Vaccination Operations Center) will then roll-out. Ground implementation will be by the many vaccination units under local government units nationwide.”

‘Welcome development’

Dr. Philip Nakpil, medical director of Zuellig Pharma Corporation, said the approval of the EUA amendment is a “welcome development in expanding Covid-19 vaccine access within our pediatric population.”

“The Spikevax COVID-19 Vaccine Moderna boosts opportunities in ensuring more children are protected against the virus,” he said in a statement.

Per Zuellig, published and peer-reviewed clinical data revealed that two 50-μg doses of the Spikevax COVID-19 Vaccine Moderna have an acceptable safety profile, and elicits a strong immune response for children aged 6 to 11.

“It was found that the efficacy and safety of the Spikevax COVID-19 Vaccine Moderna in children aged 6 to 11 are similar to those in adults,” it added

Jeff Folland, the general manager of ZP Therapeutics in the Philippines, said that the approval of the amended EUA of Spikevax COVID-19 Vaccine Moderna will further encourage parents to vaccinate their children and protect them from the severe effects of the dreaded disease.