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India’s Bharat Biotech applies for emergency use approval of COVID-19 vaccine in PH
Indian vaccine manufacturer Bharat BioTech has submitted an application to the Philippine Food and Drug Administration (FDA) for an emergency use authorization (EUA) for its COVID-19 vaccine, Covaxin.
The Department of Science and Technology (DOST) confirmed receipt of the application on January 21.
The DOST has also recently signed a confidentiality data agreement with Bharat for phase 3 clinical trials of its vaccine in the Philippines.
The vaccine expert panel and ethics board will evaluate the complete requirements for clinical trials before the FDA's final review.
Currently, only the Pfizer-BioNTech COVID-19 vaccine has received EUA from the Philippine FDA.
Other vaccine applications pending before the FDA include those from AstraZeneca, Gamaleya, and Sinovac.
The Philippine government plans to procure a total of 148 million vaccine doses from seven different manufacturers, including Bharat BioTech.
The country's COVID-19 vaccine rollout is anticipated to commence next month.
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