Ocugen is now free to resume the clinical trial of its COVID-19 vaccine, Covaxin.
Back in April, the FDA paused a phase 2/3 immuno-bridging and broadening study for the shot after an inspection by the World Health Organization revealed manufacturing discrepancies at a facility owned by India's Bharat Biotech, where the vax was developed.
Last year, Malvern-based Ocugen partnered with Bharat to co-develop and market Covaxin in North America. While more than 350 million doses have been administered to adults outside the U.S., and the vaccine authorized for emergency use in 25 countries Ocugen hasn’t had an easy road in the U.S. In 2021, the company had to work with the FDA to resolve another clinical hold having to do with the shot.
But now, after resolving the manufacturing problems outlined in this recent clinical hold, the company can continue to seek out a spot in the U.S. COVID-19 vaccine market.