MELBOURNE, 2 April 2022: The World Health Organisation (WHO) today confirmed the suspension of the supply of Covaxin produced by Bharat, through UN procurement agencies and recommended to countries that received the vaccine to take actions as appropriate.
This suspension is in response to the outcomes of the WHO post EUL inspection (14 – 22 March 2022) and the need to conduct process and facility upgrades to address recently identified GMP deficiencies.
There will be an interruption of the supply of Covaxin due to the 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.
— BharatBiotech (@BharatBiotech) April 1, 2022
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.
For continuation of vaccination with alternative sources of Covid 19 vaccines countries have been referred to the respective SAGE recommendation: https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-bbv152-covaxin
– This story is based on a WHO media release, 02 April 2022.