Indian group applies for emergency use authorization of COVAXIN in PH

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Metro Manila (CNN Philippines, January 21) — An Indian group has applied for emergency use authorization for COVAXIN, making it the fourth brand of COVID-19 vaccine to seek approval for distribution in the country.

"Ambica International Corporation and Family Vaccine (FVSC) and specialty clinics (through IP Biotech) has filed for emergency use authorization (EUA) for COVAXIN, India's indigenous vaccine in the Philippines," a statement released on Thursday said.

The EUA was filed with the Food and Drug Administration on Wednesday, it also said.

According to the statement, FVSC and Ambica International Corporation consortium signed an agreement with Bharat Biotech International Ltd., the developer of the vaccine, to distribute COVAXIN should it meet FDA standards.

"The Philippines is among the list of priority countries that Bharat Biotech will allocate supplies of COVAXIN to," the statement said.

FDA Director General Eric Domingo confirmed the receipt of the EUA application filed by COVAXIN's distributors.

"They submitted an application this morning and pre evaluation is going on," he told CNN Philippines in a text message.

Other companies seeking EUA approval are British firm AstraZeneca, Russian company Gamaleya Research Institute and Chinese drug maker Sinovac Biotech.

So far, only Pfizer-BioNTech's COVID-19 vaccine has been approved for emergency use.

An EUA issuance from regulators is required for the vaccines to be legally rolled out in the country.