THE Food and Drug Administration (FDA) of the Philippines has announced Friday that it has approved the emergency use authorization (EUA) of Moderna vaccine for adolescents aged 12 to 17.
Department of Health (DOH) Undersecretary and FDA Director-General Eric Domingo said that the manufacturer of Moderna has applied for EUA amendment two weeks ago to include its use in children 12 to 17 years old.
According to Domingo, after a thorough evaluation by its vaccine and regulatory experts, the FDA has allowed the Moderna vaccine’s use under an EUA.
The FDA was prompted to authorize the Moderna vaccine’s use as current situation of the country with the highly transmissible Delta variant affects no specific and limited age cluster, emphasizing that many children aged below 18 might even still get infected.
“With the Delta variant affecting a lot of children, the experts saw that the benefit of using the vaccine outweighs the risk,” the FDA Director-General said.
Meanwhile, following a report in Japan which discovered steel particles in Moderna vaccines, Domingo clarified that the doses recently delivered to the country were not among the batches that are under investigation.
However, Domingo still urged vaccinators and doctors to remain vigilant in monitoring potential cases of myocarditis, which was reportedly developed in individuals inoculated with Moderna and Pfizer-BioNTech’s vaccine and have been found so far in 2,574 doses administered in the United States.
Myocarditis, albeit very rare, refers to the inflammation of heart muscle which can be found mostly among younger males.
Along with the Pfizer vaccine which was allowed to be vaccinated on children aged 12 to 15 since August 2021, Moderna is the second COVID-19 vaccine which the FDA has given an approval after its application for EUA on adolescents.