The Philippine government on Friday approved the amendment in the Emergency Use Authorization (EUA) of Moderna's COVID-19 vaccine to include its use on adolescents aged 12 to 17 years old.
"After a thorough evaluation by our vaccine experts and our regulatory experts in FDA, we approved this Friday the use under EUA of the Moderna vaccine for adolescents aged 12 to 17," said Director General Eric Domingo of the Food and Drug Administration (FDA) during the Laging Handa public briefing.
Moderna filed the application to its EUA amendment to the FDA on August 19.
Domingo, however, warned of rare cases of myocarditis due to the Moderna vaccine, which he said is also similar with other mRNA vaccines. He said cases of myocarditis are one in every million and more prevalent in younger males.
"But definitely with the Delta variant affecting a lot of children, our experts saw that the benefit of using the vaccine outweighs the risk," Domingo said.
In an interview on Super Radyo dzBB, Domingo said myocarditis, which is an inflammation of the heart muscle, is curable if detected early.
Domingo said Moderna doses delivered to the country are not from the batches under investigation for possible contamination in Japan.
On whether 12 to 17 year olds could now apply for vaccination following the government approval, Domingo said the prioritization of age groups will still come from the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) and the Department of Health.
He said the government is already looking into whether to allow adolescents with comorbidities to have their vaccination.
"Perhaps this October, fourth quarter of the year, children will be allowed to have their vaccination," he said on dzBB.
Children with comorbidities include those with obesity, high blood, diabetes, and congenital or metabolic disorders, he said.
Domingo said side effects on children are mild compared to adults. He said these include mild pains and fever.
Health Secretary Francisco Duque III has earlier voiced support to the vaccination of minors against COVID-19, provided that there are enough vaccine supplies.
Secretary Carlito Galvez Jr., the country's vaccine czar, said on August 8 that vaccination of minors aged 12 to 17 may start in September or October depending on the vaccine supply.
The FDA said the country will have to vaccinate an additional 12 to 14 million people if the government allows the vaccination of children aged 17 and below against COVID-19. —KBK, GMA News