FDA adds India's Covaxin to authorized COVID-19 vaccines

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FDA adds India's Covaxin to authorized COVID-19 vaccines
A medical worker displays a vial of the Covaxin vaccine against the COVID-19 coronavirus at a vaccination center in Mumbai on May 9, 2021.
AFP / Indranil Mukherjee

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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