By Ma. Teresa Montemayor
MANILA – Food and Drug Administration (FDA) Director General Eric Domingo on Friday confirmed the country has granted full emergency use authorization to India-based Bharat Biotech’s COVID-19 vaccine called Covaxin.
Covaxin was earlier given only an EUA conditional on its submission of Good Manufacturing Practices (GMP) certification.
“Nung nakalipas kasi meron pa silang hindi na-submit na certificate sa amin. Bagamat pumasa na raw sila sa inspection sa good manufacturing practice, hindi pa nila na-submit ‘yung actual certificate,” Domingo said in a televised public briefing.
This prohibited Bharat Biotech from importing its COVID-19 vaccine, 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 which teach the immune system to prepare a defense mechanism without infecting the person.
“Na-submit nila last week, so ngayon pwede na sila mag-import at pwede na rin gamitin dito sa bansa natin ‘yung Covaxin na bago pong vaccine mula sa India,” Domingo said.
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. (PNA)-rir
