The US Food and Drug Administration (FDA) has suspended a Phase 2/3 clinical trial of Bharat Biotech’s COVID-19 vaccine Covaxin in the US According to a press release from Ocugen Inc, Bharat Biotech’s Covaxin partner in the US and Canada, the FDA’s decision was based on the U.S. company’s decision to voluntarily temporarily suspend injectable participants following the World Health Organization’s observation of Covaxin. Manufacturing plant in India.

Ocugen said on April 12 that it was the result of the company’s decision to voluntarily temporarily suspend dosing participants of OCU-002 while it evaluated a statement issued by the World Health Organization following inspections of Bharat Biotech International Limited’s (BBIL) manufacturing facility. The WHO had earlier suspended the supply of Covaxin through its US procurement agency after its inspectors found GMP (good manufacturing practice) deficiencies at Bharat Biotech’s manufacturing facility.

The city-based company said it did not supply any UN agency with a Covid vaccine and therefore would not feel the impact of the suspension, the sources said. OCU-002 is Ocugen’s Phase 3 immune bridging study of Covaxin.
The company said it would work with the FDA to resolve any issues. The FDA in February removed clinical control of Ocugen’s investigational new drug application (IND) to evaluate Covaxin.

Following the WHO inspection, Bharat Biotech had said that it was temporarily slowing Covaxin production at its manufacturing unit to optimise the facility as it had fulfilled its supply obligations to sourcing agencies and expected a demand reduction. The company further stated that, following the recent WHO Emergency Use List (EUL) inspection, it is working on further improvements and upgrades to ensure that Covaxin production continues to meet growing global regulatory requirements.