Bharat Biotech stated on Monday that its partner Ocugen's Phase 2/3 Investigational Drug Application for Covaxin COVID-19 vaccine has been cleared by the United States Food and Drug Administration (FDA) for conducting trials in adults.
In late 2020, Ocugen had entered into a deal with vaccine maker Bharat Biotech to develop, supply, and commercialise Covaxin for the US market. In a tweet, Bharat Biotech stated that it and Ocugen are "fully committed towards bringing Covaxin in the United States and Canada for all age groups".
"Recently, Ocugen's Phase 2/3 Investigational Drug Application for Covaxin was cleared by the U.S. Food and Drug Administration (FDA) for conducting clinical trials in adults. Ocugen intends to continue working with FDA to evaluate regulatory pathway for the pediatric use of Covaxin," added Bharat Biotech.
On Friday, Ocuggen had stated that the US regulator 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.
In a tweet, Ocugen had clarified that the FDA declining EUA of Covaxin had no "impact on the company's IND application. Our Phase 2/3 adult immuno-bridging trial for our #COVID19 #vaccine candidate is proceeding as planned and we are excited to initiate enrollment".
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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