FDA Lifts Clinical Hold on Ocugen COVID-19 Vaccine Clinical Trial

The FDA has lifted a clinical hold it placed on Malvern, Pa.-based Ocugen’s COVID-19 vaccin, Covaxin (BBV152) in April following a World Health Organization (WHO) inspection that found quality lapses at a manufacturing facility in India.

Covaxin is an inactivated COVID-19 vaccine that is approved in India for the adult population and manufactured there by Bharat Biotech. The FDA has not approved Covaxin for use in the U.S.

The WHO granted the vaccine an emergency use listing (EUL) in November 2021 but suspended the supply in April following its inspection of a Bharat Biotech facility. The WHO asked the company to make specific changes to the facility to handle COVID-19 vaccines.