HYDERABAD: The US Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s Covid-19 vaccine Covaxin in the US.
According to a press release by Ocugen Inc, Bharat Biotech’s partner for US and Canada for Covaxin, the FDA’s decision was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab following the World Health Organisation’s observations on Covaxin manufacturing plants in India.
WHO had earlier suspended the supply of Covaxin through US procurement agencies after its inspectors identified GMP (good manufacturing practice) deficiencies in Bharat Biotech’s manufacturing plants.
Sources had said the firm, however, said it had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. The FDA in February lifted its clinical hold on Ocugen’s Investigational New Drug application to evaluate Covaxin.
After the WHO inspection, Bharat Biotech had said it is temporarily slowing down production of Covaxin across its manufacturing units for facility optimisation.PTI
