FDA declines pediatric EUA for Ocugen’s COVID vaccine Covaxin

✔ Fact Checked by TDPel News Desk

By Samantha Allen

Published: March 7, 2022 | 8:03 AM

Ocugen Inc (OCGN.O) said the U.S. regulators have declined to issue an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use in individuals aged 2 to 18 years.

Shares of Ocugen slumped 30% premarket on the news.

Ocugen said it intends to continue working with the U.S. Food and Drug Administration to evaluate the process for getting an EUA for pediatric use of Covaxin.

Ocugen had entered into a deal with vaccine maker Bharat Biotech in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market.

Covaxin, which is not cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and also has an emergency use listing from the World Health Organization.

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About Samantha Allen

Samantha Allen is a seasoned journalist and senior correspondent at TDPel Media, specializing in the intersection of maternal health, clinical wellness, and public policy. With a background in investigative reporting and a passion for data-driven storytelling, Samantha has become a trusted voice for expectant mothers and healthcare advocates worldwide. Her work focuses on translating complex medical research into actionable insights, covering everything from prenatal fitness and neonatal care to the socioeconomic impacts of healthcare legislation. At TDPel Media, Samantha leads the agency's health analytics desk, ensuring that every report is grounded in accuracy, empathy, and scientific integrity. When she isn't in the newsroom, she is an advocate for community-led wellness initiatives and an avid explorer of California’s coastal trails.