India’s First Indigenous Vaccine Accepted by WHO and Submitted for Pediatric EUA in America

Indian biotech Bharat Biotech recently reported that its inactivated Vero cell production platform-based COVID-19 vaccine known as COVAXIN®, authorized on an emergency basis in India back in January, received acceptance by the World Health Organization (WHO). The BBV152 or COVAXIN vaccine was included in the global health agency’s Authorized Emergency Use Listing for COVID-19 immunization. While TrialSite reported early on some concerns that the product approval in India was rushed, Bharat Biotech continued to accelerate vaccine development worldwide inking a deal to develop and commercialize the vaccine in America via a partnership with Ocugen. Just this month U.S.-based Ocugen announced submission of a pediatric Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for COVAXIN based on an immune-bridging clinical trial in children, ages 2-18. Apparently, the results demonstrated comparable neutralizing antibody response as seen in a larger adult Phase 3 clinical trial conducted in India.

What is COVAXIN?

COVAXIN is a newly developed investigational vaccine for COVID-19 that has been authorized by the World Health Organization for emergenc...

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