U.S. drug regulator lifts clinical hold on Ocugen’s COVID vaccine trial
May 23, 2022, 7:33 AM EDT
(Reuters) – Ocugen Inc (OCGN.O) said on Monday the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by its Indian partner Bharat Biotech.
The Food and Drug Administration paused the trials of the shot, Covaxin, in April after an inspection of a Bharat Biotech facility by the World Health Organization (WHO) revealed deficiencies in the manufacturing process.
“Ocugen will now work with study sites to fully resume this clinical development program immediately,” Chairman and Chief Executive Officer Shankar Musunuri said in a statement.
The U.S.-based company is responsible for conducting trials and commercialization of the vaccine in the United States under a partnership with Bharat Biotech.
Covaxin is not cleared for use in any age group in the United States, but is one of the two most widely used COVID vaccines in India and has received emergency use listing from the WHO.
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