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FDA Rejects Non-MRNA COVID-19 Vaccine For Children: Company

fda-rejects-non-mrna-covid-19-vaccine-for-children:-company

Ocugen said the U.S. Food and Drug Administration (FDA) declined to issue an emergency use authorization for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for children. The biopharmaceutical company said it intends to continue working with the FDA to evaluate the process for getting an emergency use authorization for pediatric use of Covaxin, it said in a March 4 statement that announced the health agency’s decision. The company had sought to authorize the shot for children aged 2 to 18. Ocugen had entered into a deal with vaccine maker Bharat in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market. Covaxin, which isn’t 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. A large-scale clinical trial found that …  » Read full article

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