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Manila Bulletin devider Philippines devider National devider FDA says Moderna, Sinovac 'not yet ready' to seek authorization for their jabs to be used for children

FDA says Moderna, Sinovac 'not yet ready' to seek authorization for their jabs to be used for children

Published Jun 25, 2021 02:08 pm

(MANILA BULLETIN FILE PHOTO)

Vaccine developers Moderna and Sinovac Biotech are not yet ready to apply for an authorization to expand the use of their respective coronavirus disease (COVID-19) vaccines to children, the Food and Drug Administration (FDA) said on Friday, June 25.

FDA Director-General Rolando Enrique Domingo said that the two companies told his agency that they are still completing the necessary data.

"Both companies ay hindi pa sila ready mag apply. I think they are compiling yung data from their clinical trial, involving children below 18 years old (Both companies are not ready to apply yet. I think they are compiling the data from their clinical trial, involving children below 18 years old)," said Domingo during a public press briefing.

"Kapag ready na iyon, saka sila maga-apply ng expansion ng kanilang EUA (Once that is ready, then they will apply for the expansion of their EUA)," he added.

The Sinovac and Moderna COVID-19 vaccines should be used only for individuals 18-years-old and above as indicated in their respective EUA that was granted by the FDA.

Only the vaccine made by Pfizer-BioNTech can be administered to people aged 12 and above.

Covaxin

The Covaxin, which is the COVID-19 vaccine made by Bharat Biotech, can now be imported to the Philippines after it secured a full EUA, said Domingo.

Last April, the FDA announced that it granted an EUA to Covaxin but it is only now that Bharat Biotech has submitted the other requirement ---which was the certificate of Good Manufacturing Practice, noted Domingo.

“Pero na submit na nila last week. Ngayon maari na po silang mag import at maari na pong gamitin din sa bansa natin yung Covaxin na galing India (But they already submitted it last week. Now, they can import and it can also be used in our country---this Covaxin from India),” he said.

This vaccine can only be used to individuals 18 years old and older. It has an efficacy of 80.6 percent against COVID-19.

Related Tags

moderna Sinovac COVAXIN Food and Drug Administration
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