FDA evaluating 3 applications for kids, teens’ jabs

MANILA, Philippines — The Food and Drug Administration (FDA) is evaluating applications of three vaccine makers for an amendment to their emergency use authorization (EUA) to allow the use of their jabs for children and teens.

Bharat Biotech’s Covaxin, Sinovac’s CoronaVac, and the vaccine developed by China state-owned Sinopharm currently have pending EUA amendment applications before the FDA, acting Director-General Oscar Gutierrez told President Rodrigo Duterte in the weekly taped “Talk to the People” that aired late Monday night.

“If these three will pass our clinical evaluation and the standards of the FDA, we will have five vaccines for the immediate future,” he said in Filipino.

Bharat Biotech is applying for an EUA amendment for the use of Covaxin on those aged 2 to 18.

Sinovac’s application is for the use of its vaccine on those aged 3 to 11 and 12 to 17.

Sinopharm has an application for the use of its vaccine on those aged 3 to 17.

The FDA has only so far approved the use of Moderna and Pfizer vaccines on those aged 12 and above. Pfizer’s vaccine for use on those aged 5 to 11 has also been approved.

At present, the youngest who can receive COVID-19 jabs in the country are those aged 12.

The government is eyeing to start the vaccination of those aged 5 to 11 by February.

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ATM