FDA: Sinovac, Moderna not yet ready to seek green light for children's use


Posted at Jun 25 2021 02:35 PM

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China's Sinovac Biotech and American biotech firm Moderna are not yet ready to apply for a wider emergency use authorization to allow the use of their COVID-19 vaccines for children, the Philippine drug regulator said on Friday. 

"Both companies po ay hindi pa raw sila ready mag-apply," said Food and Drug Administration (FDA) chief Eric Domingo. 

"I think they are compiling pa po ‘yong data from their clinical trial involving children na below 18 years old. Kapag ready na ‘yon saka pa lang po sila mag-a-apply ng expansion ng kanilang EUA," he said in a televised public briefing.
(Both companies said they were not yet ready to apply. I think they're compiling the data from their clinical trial involving children na below 18 years old. Once they are ready, that's when they would apply for an expansion of their emergency use authorization.)

In addition, the Philippines has authorized only one vaccine — that of Pfizer-BioNTech — for use of 12 to 15-year-olds. 
The country's current Pfizer supply is donated by the vaccine-sharing COVAX Facility, which provides jabs for the 5 priority groups that do not include children, Health Undersecretary Myrna Cabotaje noted earlier this week. 

The Philippines expects to take delivery of 7.5 million Pfizer jabs in the third quarter and 32.5 million more doses of the same vaccine in the fourth quarter, said the official. 

"Depende po sa dami ng makukuhang mga bakuna over the next few months, titingnan po kung maisasama na ‘yong mga child population," Cabotaje said in a televised public briefing. 

"Malamang end of the year and beginning of next year pa natin makikita kung babakunahan itong ating mga teenagers," she added. 

(It is likely that it will take until the end of the year and the beginning of next year for us to see if teenagers could be vaccinated.)