In April of last year—soon after receiving a $200 million government grant from India to beef up its manufacturing capacity—Bharat Biotech proclaimed an ambitious goal to produce 700 million COVID-19 vaccines annually.
Reaching that figure won’t be easy in the near future considering the regulatory setbacks Bharat and its U.S. commercial partner Ocugen have faced.
The most recent came this week when the FDA put a clinical hold on an immuno-bridging study by Ocugen designed to show that Bharat’s vaccine could protect people in the U.S. as effectively as it has done in trials in India.
The FDA action came after the World Health Organization suspended the supply of Covaxin on April 2. That followed a March walkthrough of Bharat plants, where inspectors identified deficiencies in good manufacturing practices (GMP). In response, Bharat suspended the production of Covaxin for export.
In its release on Tuesday, Malvern, Pa.-based Ocugen said that the FDA’s clinical hold came after it had voluntarily halted dosing of patients in the bridging trial while “it evaluates statements” made by the WHO following its inspection.
“We will work with the FDA to address any questions,” Ocugen said.
This is the second time the U.S. regulator has put a hold on Ocugen’s investigational new drug application for Covaxin. The first came in November when Ocugen reported the delay and said it was awaiting word from the FDA about how to address “deficiencies” in the application. The hold was lifted two months ago.
Ocugen had asked for a pediatric approval in the U.S., stressing that its traditional-style vaccine is similar to the shot commonly provided to children to defend against polio. But that request was denied last month by the FDA.
Covaxin is approved in 14 countries including India, Malaysia, Mexico and the Philippines. It was sanctioned by the WHO late last year. More than 125 million doses of the shot were administered in 2021.