New Delhi: The US Food and Drug Administration has suspended the Phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin in the US.
According to a press release from India Biotech’s partner Ocugen Inc for the US and Canada for Covaxin, the FDA’s decision, following the World Health Organization’s comments on Covaxin, was to voluntarily implement temporary pauses in those taking the jab. was based on the decision of the American firm. Manufacturing Plant in India.
Ocugen said on April 12 that this is a result of the company’s decision to voluntarily implement a temporary pause in participants taking OCU-002 supplements, while it is following an inspection of a Bharat Biotech International Limited (BBIL) manufacturing facility at World Healthcare. Evaluates the statements made by the organization. ,
The WHO had earlier suspended the supply of Covaxin through US procurement agencies after its inspectors identified GMP (good manufacturing practice) deficiencies at Bharat Biotech’s manufacturing plants.
Sources had said that the city-based firm, however, said that it has not supplied the COVID vaccine to any UN agency and no impact of the suspension would be felt.
OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.
The company said it would work with the FDA to address any questions. In February, the FDA lifted its clinical hold on Ocugen’s Investigational New Drug Application (IND) to evaluate Covaxin.
Following the WHO inspection, Bharat Biotech had said that it is temporarily slowing production of Covaxin at its manufacturing units for facility optimization as it has already met its supply obligations to procurement agencies and demand has increased. Predicts shortage.
The company further said that following the recent WHO Post Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that Covaxin production continues to meet the ever-increasing global regulatory requirements.
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