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.
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.