Ocugen : FDA Has Placed Co.'s Covid Vaccine Trial on Clinical Hold

By Will Feuer

Biopharmaceutical company Ocugen Inc. said it has been informed by the U.S. Food and Drug Administration that the agency has placed the company's Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine candidate on clinical hold.

The company said the decision is a result of Ocugen's move to voluntarily pause the dosing of study participants after the World Health Organization identified deficiencies in good manufacturing practices during an inspection of Bharat Biotech International Ltd.'s vaccine plant.

Ocugen said it will work with the FDA to address any questions. The vaccine candidate is BBV152, also known as Covaxin outside the U.S.

Earlier this month, the WHO halted the supply of Covaxin through United Nations procurement agencies, and recommended that countries using the vaccine "take action as appropriate."

Shares of Ocugen fell more than 5% to $2.75 a share in premarket trading.

Write to Will Feuer at [e-mail]

(END) Dow Jones Newswires

04-12-22 0908ET