The World Health Organization (WHO) is today confirming the suspension of supply of Covaxin produced by Bharat, through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate.
This suspension is in response to the outcomes of WHO post EUL inspection (14 – 22 March 2022) and the need to conduct process and facility upgrade to address recently identified GMP deficiencies.
There will be interruption of supply of Covaxin due to suspension of production for export.
Bharat 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, Bharat has indicated its commitment to suspend its production of Covaxin for export.
The risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists.
For continuation of vaccination with alternative sources of Covid 19 vaccines countries should refer to the respective SAGE recommendation: https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-bbv152-covaxin
COVID-19 vaccines WHO EUL issued: https://extranet.who.int/pqweb/vaccines/vaccinescovid-19-vaccine-eul-issued