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, according to the maker of the shot. Ocugen said in a news release, announcing the health agency’s decision, that it intends to continue working with the FDA to evaluate the process for getting an emergency use authorization for pediatric use of Covaxin. The company had sought to authorize the shot for children aged 2 to 18. 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. A large-scale clinical …
FDA Rejects Non-mRNA COVID-19 Vaccine for Children: Company
March 7, 2022
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