FDA approves use of Moderna vaccines for adolescents in PH

The Food and Drug Administration (FDA) has approved the emergency use of Moderna COVID-19 vaccine on adolescents aged 12 to 17 in the Philippines.

(FILES) In this file photo Medical workers load syringes with the Moderna Covid-19 vaccine to be administered by nurses at a vaccination site at Kedren Community Health Center, in South Central Los Angeles, California on February 16, 2021. (AFP/MANILA BULLETIN)

FDA Director-General Eric Domingo confirmed that the amended emergency use authorization to include individuals aged 12 to 17 was approved Friday, Sept. 3, two weeks after the application.

"After thorough evaluation by our vaccine experts and regulatory experts from the FDA, in-approve na po namin ngayong araw na ito ang paggamit ng (we have already approved today the use of the vaccine) under emergency use for adolescents aged 12 to 17," Domingo said during a televised briefing.

While the vaccine has been approved for the age group, the vaccination of these individuals will still be according to the prioritization rules set by the interagency task force (IATF) on vaccination.

"Sinabi natin na maaari siyang gamitin sa 12 to 17 yo pero yun pong pagpa-prioritize kung sino ang mababakunahan at kung ano ang age group sa DOH o IATF pa rin. So kapag nag-decide na nila na aabot na tayo sa prioritization of less than 18 years old, doon magbabakuna na ng mga bata (We are saying that it can now be used on person aged 12 to 17 but the prioritization list is still up to the Department of Healt or IATF. When they decide to prioritize the age group, it is when we can finally vaccinate the adolescents)," Domingo explained.

In vaccinating adolescents using the Moderna vaccine, usual precautions will still be observed. Vaccinators and doctors will need to watch out for the "very rare cases of myocarditis."

Meanwhile, Domingo said the FDA will be ready to go through the application for certification for Pfizer once it seeks full approval in the country.

The vaccine has been approved by the US FDA for use on people aged 16 and up and emergency use for individuals aged 12 to 15.

"'Pag nakakuha sila dito ng approval or yung certificate of product registration, ibig sabihin po nun maaari nang ibenta sa mga botika, sa mga ospital, ireseta ng doktor ang bakuna at magiging accessible na ito sa private sector (Once it obtains approval or certificate of product registration, it will be available in pharmacies, hospitals, can finally be prescribed by doctors, and be accessible to the private sector)," the FDA chief said.