On Wednesday, Bharat Biotech’s partner Ocugen was asked to put a hold on the ongoing 2/3 phase trials of covaxin. The USFDA’s latest action comes on the heel of WHO’s decision to regulate all the covaxin supplies after it found the manufacturing procedure was not up to the GMP standards.

Ocugen stated that it will work with the FDA to address the issues. Bharat Biotech also shared that it is addressing the GMP deficiencies and framing a preventive plan of action for submission to DCGI and WHO. In the Intermittent gap, the company has suspended production of the vaccine for export.

Meanwhile, WHO has briefed that risk assessment doesn’t change the risk-benefit ratio.

(Source: https://health.economictimes.indiatimes.com/news/pharma/us-asks-bharat-bio-partner-ocugen-to-halt-covaxin-trials/90832044 )