FDA: Sinovac, Moderna not yet ready to apply for aged below 18 vaccine use
MANILA, Philippines — Sinovac and Moderna are both not yet ready to apply for an expansion of their respective vaccines’ emergency use authorization (EUA) for persons aged below 18 years pending more data from their clinical trials, the Food and Drug Administration (FDA) said Friday.
“Tinanong na rin po namin yung ibang mga vaccines katulad nga po ng Sinovac at Moderna kung sila ay mageexpand din kasama po yung mga bata,” FDA chief Eric Domingo said in a televised briefing.
(We have asked other vaccine developers like Sinovac and Moderna if they will also expand their EUA to include younger people.)
“Pero pareho, both companies po ay hindi pa daw po sila ready mag-apply. I think they’re compiling pa po yung data from their clinical trials involving children below 18 years old,” he added.
(But both companies said they are not yet ready to apply. I think they’re compiling data from their clinical trials involving children below 18 years old.)
COVID-19 vaccine doses from Sinovac and Moderna can be given to persons 18 years old and above, according to their respective EUAs.
In China, Sinovac’s CoronaVac vaccine has been approved for use in children as young as 3-years-old to 17-years-old. Meanwhile, Moderna has reported its vaccine to be safe and effective for children 12-yers-old to 17-year-old.
The COVID-19 vaccine developed by Pfizer-BioNTech is so far the only one approved for use on those aged 12 to 15.
The government said it is eyeing to start the vaccination of the pediatric sector by September or October.
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