Covaxin gets full EUA, can now be imported to PH – FDA

MANILA, Philippines — Covaxin, the COVID-19 vaccine developed by India’s Bharat Biotech, can now be imported to the Philippines after it was granted a full emergency use authorization (EUA) by the Food and Drug Administration.

Although it was approved for emergency use in April, FDA chief Eric Domingo explained Covaxin only secured a full EUA now after Bharat Biotech submitted the certificate of the good manufacturing process to the agency.

“Bagamat pumasa na sila doon sa kanilang inspection for good manufacturing practice, di pa nila na-submit yung actual na certificate kaya hindi sila maaaring mag-angkat at magamit ang bakuna hanggang ma-submit nila lahat yun. Pero na-submit na nila last week,” Domingo explained in a televised briefing.

(Although they passed the inspection for good manufacturing practice, they had not submitted the actual certificate that’s why they couldn’t import nor have their vaccine used until it was submitted. But they finally submitted the certificate last week.)

“So ngayon, maaari na po silang mag-import at maaari na pong gamitin din sa bansa natin. ‘Yung Covaxin po ito na bago pong vaccine galing India,” he added.

(So now, they can import the vaccine and use it here in the Philippines. This is Covaxin, a new vaccine from India.)

READ: PH approves emergency use of J&J, Bharat Biotech vaccines

Domingo previously said Covaxin can be administered to people aged 18 and above.

The Philippines and India had been in talks for eight million or more doses of Covaxin, India’s ambassador to the Philippines Shambhu Kumaran previously said.

KGA