<p><span style="background-color:transparent;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">Today, WHO confirmed the suspension of supply of Covaxin (Bharat Biotech) through UN procurement agencies, and recommended that countries using the vaccine take action as appropriate.</span></p><p><span style="background-color:transparent;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">The suspension is in response to the outcome of a WHO inspection on 14 – 22 March 2022, and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP).</span><br /></p><p><span style="background-color:transparent;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">Bharat Biotech has committed to 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 that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future.</span><br /></p><p><span style="background-color:transparent;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">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 concerns exist.</span><br /></p><p><span style="background-color:transparent;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;">For continuation of vaccination with alternative sources of Covid 19 vaccines, countries should refer to the respective SAGE recommendation: </span><a href="https://www.who.int/publications/m/item/considerations-for-the-assessment-of-covid-19-vaccines-for-listing-by-who" style="font-size:inherit;font-family:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;" target="_blank">Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO</a><span style="background-color:initial;color:#333333;font-size:inherit;font-family:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;caret-color:auto;"></span></p>
