Ocugen Faces Setback on Launching U.S. Trial of COVID-19 Shot

The FDA has placed a clinical hold on Ocugen’s Investigational New Drug (IND) application for BBV152, the company’s COVID-19 vaccine candidate known as Covaxin outside the U.S.

The company didn’t disclose much information, saying only that it expects to hear from regulators soon about “the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies.”

In June, FDA denied Ocugen an Emergency Use Authorization, saying that the company needed to conduct a U.S. trial.

The news of a clinical hold comes on the heels of two recently published studies with divergent efficacy findings.