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Manila Bulletin devider Philippines devider National devider FDA: India's Bharat Biotech applies for EUA for its Covaxin

FDA: India's Bharat Biotech applies for EUA for its Covaxin

Published Jan 21, 2021 02:37 pm

The Food and Drug Administration (FDA) said on Thursday that India's Bharat Biotech has filed an application for emergency use authorization (EUA) for its COVID-19 vaccine Covaxin.

(MANILA BULLETIN)

Bharat Biotech is the fifth pharmaceutical company that has submitted an application for an EUA in the Philippines.

" submitted an application this morning and pre-evaluation is going on," said FDA Director-General Rolando Enrique Domingo.

The FDA has so far approved the EUA application of United States-based drug-maker Pfizer for its COVID-19 vaccine.

Other companies that already applied for an EUA were Russia’s Gamaleya Research Institute, China’s Sinovac Biotech, and Britain’s AstraZeneca.

“These applications are now being studied. They still need to complete the required documents needed by the Food and Drug Administration (FDA),” said Department of Health (DOH) Undersecretary Maria Rosario Vergeire.

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