US FDA now puts Covaxin on hold after WHO's observations

The US Food and Drug Administration has put the second and third phase trials of Bharat Biotech’s vaccine Covaxin in USA on hold. This comes in the wake of the World Health Organisation having recently suspended the supply of Covaxin through US procurement agencies, after its inspectors found GMP (good manufacturing practice) shortcomings in the manufacturing plants of Bharat Biotech.

Meanwhile, a press release issued by Ocugen Inc, who is Bharat Biotech’s partner for US and Canada for Covaxin, said that the FDA had taken this step, after the US firm had on its own voluntarily stopped giving the dose to participants of the trial following WHO’s observations on Covaxin manufacturing plants in India.

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Ocugen said, “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002, while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility.” OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

The company further said that it will cooperate with FDA to address any questions.

After WHO’s inspection, Bharat Biotech decided to slow down Covaxin production for a temporary period to be able to optimize its facility. Having met all its current obligations and with the decrease in demand, the company will focus on improvements and upgrades in the production of Covaxin, to meet the growing global regulatory requirements.