FDA adds India's Covaxin to authorized COVID-19 vaccines
MANILA, Philippines — The country’s Food and Drug Administration has granted full emergency use authorization to the COVID-19 vaccine developed by Bharat Biotech, paving the way for the importation of jabs.
FDA Director General Eric Domingo said the Indian firm submitted last week a certificate for good manufacturing practices, which is a requirement for the importation of its vaccine called Covaxin.
Bharat Biotech secured a conditional EUA last April.
“They can now import. The vaccine can now be used here in our country,” Domingo said in Filipino in a briefing.
Covaxin is an inactivated vaccine that requires two doses. It was cleared for use in individuals aged 18 and older.
The jab was reported to have an efficacy of 77.8% based on data from a Phase 3 trial.
The local drug regulator has so far cleared for emergency use COVID-19 jabs from Pfizer-BioNTech, AstraZeneca, Sinovac Biotech, Gamaleya Research Institute, Johnson&Johnson, and Moderna.
Only 1.7% of the country’s roughly 110 million population have been fully vaccinated against COVID-19 since the inoculation drive began in March, while 4.6% have received the first of two doses of the vaccine.
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