Sun. Aug 1st, 2021

Food and Drug Administration (FDA) Director General Eric Domingo on Friday confirmed that the agency has granted full emergency use authorization (EUA) to India-based Bharat Biotech’s vaccine for the coronavirus disease 2019 called Covaxin.

(photo courtesy: http://www.nature.com)

Covaxin was earlier given only an EUA conditional on its submission of Good Manufacturing Practices (GMP) certification.

Earlier there’s a certificate they haven’t submitted. Even though they have passed the good manufacturing practice inspection, they haven’t submitted the actual certificate,” Domingo said in Filipino in a televised public briefing.

This prohibited Bharat Biotech from importing its Covid-19 vaccine into the Philippines, he added.

Covaxin is an inactivated viral vaccine with an 81-percent efficacy rate. Developed with whole-virion inactivated vero cell-derived technology, it contains inactivated viruses that teach the immune system to prepare a defense mechanism without infecting the person.

They have submitted the certificate last week, so they can now import and Covaxin, a new vaccine from India, can now be used in our country,” Domingo said in Filipino.

Apart from Covaxin, the FDA has granted EUA to Pfizer-BioNTech, Oxford–AstraZeneca, Sinovac, Sputnik V, Janssen, Moderna, and Sinopharm.

The Philippines is the ninth country to grant Covaxin an EUA. 

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