Covaxin, Janssen approved for emergency use in PH

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Metro Manila (CNN Philippines, April 19) — The Covaxin and Janssen vaccines can now be used in the country after both were granted emergency use authorization by the Food and Drug Administration.

FDA Director General Eric Domingo confirmed the EUA approvals on Monday.

India's Ambassador to the Philippines Shambhu Kumaran first broke the news about Covaxin on social media Monday, tweeting, "Delighted that #Covaxin has been granted EUA in the #Philippines. Congratulations @BharatBiotech! Thank you @FDAPhilippines."

In an interview with CNN Philippines in March, Kumaran said Covaxin has an efficacy rate of 81% following large-scale clinical trials that involved over 25,000 participants. 

Covaxin is an inactivated virus-based vaccine product that uses a killed form of SARS-CoV-2, one of the oldest and tried-and-tested methods of prompting an antibody response.

In the same interview, Kumaran said the company's local representatives have been in contact with concerned officials for a possible purchase, adding they would be ready to supply the country an initial batch of at least 8 million vaccine doses.

Covaxin is jointly developed by Bharat Biotech and government-run Indian Council of Medical Research.

Meanwhile, Domingo earlier said that he expected Janssen to be granted an EUA.

Janssen is a single-dose vaccine developed by American drugmaker Johnson & Johnson which applied for an EUA last March 31.

Janssen's approval was acknowledged by vaccine czar Carlito Galvez during President Rodrigo Duterte's address on Monday night.

"Yung Johnson & Johnson nagpapasalamat po tayo sa FDA kasi lumabas na po 'yung kanyang EUA," Galvez said.

[Translation: We want to thank the FDA because Johnson & Johnson's EUA has been approved.]

Pfizer-BioNTech, Oxford-AstraZeneca, Sinovac, and Gamaleya-Sputnik V were also previously granted EUAs by the FDA.