FDA Halts Phase 2/3 Trials of Covaxin Amid Manufacturing Concerns
The US Food and Drug Administration (FDA) has temporarily halted the phase 2/3 clinical trials of Covaxin, a COVID-19 vaccine developed by Bharat Biotech, in the United States. This decision comes in response to a voluntary pause in dosing participants by Ocugen Inc., Bharat Biotech’s partner for the vaccine’s distribution in the US and Canada. The pause was initiated following the World Health Organization’s (WHO) observations on the manufacturing facilities of Covaxin in India.
WHO’s Manufacturing Concerns Prompt Voluntary Pause in Covaxin Trials
Ocugen Inc., in a press release, revealed that the pause in dosing participants of their Phase 3 study of Covaxin (OCU-002) is a direct result of concerns raised by WHO regarding Bharat Biotech’s manufacturing facilities. WHO had suspended the supply of Covaxin through US procurement agencies after identifying deficiencies in good manufacturing practices (GMP) at Bharat Biotech’s plants.
Collaboration with FDA and Steps Forward for Covaxin
Ocugen Inc. stated that it will collaborate with the FDA to address any questions arising from the situation. The FDA had previously lifted its clinical hold on Ocugen’s Investigational New Drug application (IND) to evaluate Covaxin. Despite the pause, Ocugen and Bharat Biotech remain committed to ensuring the vaccine’s compliance with global regulatory requirements.
Bharat Biotech’s Response and Future Plans
Bharat Biotech, in response to WHO’s observations, announced a temporary slowdown in Covaxin’s production across its manufacturing units for facility optimization. The company emphasized that its supply obligations to procurement agencies had already been fulfilled, and any suspension of supply wouldn’t impact ongoing vaccination efforts. The recent WHO inspection has prompted the company to focus on further improvements and upgrades to meet increasing global regulatory standards.
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