The World Health Organization (WHO) has suspended the supply of Covaxin, produced by city-based Bharat Biotech, through UN procurement agencies and recommended to countries that received the covid vaccine to take action as appropriate.
A statement issued by WHO on Saturday said the suspension is in response to the outcomes of its post-EUL (emergency use authorisation) inspection held between March 14-¨C22, 2022, and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
There will be an interruption of the supply of Covaxin due to the suspension of production for export, WHO said. The risk assessment to date does not indicate a change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists, WHO said.
Bharat Biotech on April 1 announced the temporary slowing down of production of its covid-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.
¡°For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,¡± said the Company.?
¡°Certain highly sophisticated equipment which was required to enhance the process stringency were unavailable during the COVID-19 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,¡± the company noted.
During the recent WHO inspection, Bharat Biotech agreed with the former's team on the scope of the planned improvement activities and indicated that they will be executed as soon as possible.
The company has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO.
In the interim and as a precautionary measure, the company has indicated its commitment to suspend its production of Covaxin for export, WHO said.
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