Indian vaccine gets FDA emergency use authorization | Inquirer News

Indian vaccine gets FDA emergency use authorization

/ 05:12 AM June 26, 2021

Covaxin gets full EUA, can now be imported to PH – FDA

FILE PHOTO: Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. REUTERS/Adnan Abidi

MANILA, Philippines — India’s Bharat Biotech may now ship its vaccines against COVID-19 to the country as it has secured a full emergency use authorization (EUA) from the Food and Drug Administration (FDA).

Eric Domingo, FDA director general, said the full EUA was given to Bharat Biotech’s Covaxin after it submitted a good manufacturing practice certificate as required by the FDA.

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Domingo explained that without this certificate, it would be unable to bring the vaccine into the county. ‍

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“But they submitted it last week, so now they could import and use [the vaccine] in the country,” Domingo said at an online briefing.

The private sector had ordered 8 million doses of Bharat’s Covaxin. —Leila B. Salaverria

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