Bharat Biotech Covaxin News: Bharat Biotech to suspend Covaxin production for export, rectify issues raised by WHO

Bharat Biotech clarified in a statement that there is "no impact on efficacy and safety of the COVID-19 vaccine Covaxin". 

Created On: Apr 5, 2022 14:20 IST
Bharat Biotech to temporarily slowing down Covaxin production for facility optimisation
Bharat Biotech to temporarily slowing down Covaxin production for facility optimisation

Bharat Biotech Covaxin News: Bharat Biotech has informed that it will rectify issues raised by the World Health Organization regarding Covaxin, its COVID-19 vaccine, within 15-20 days. The Hyderabad-based pharmaceutical company was informed about the development to the Drugs Controller General of India (DCGI) and Union Health Ministry.

This comes after WHO suspended the supply of Covaxin through United Nations agencies. The World Health Organization said on April 3, 2022 that it has suspended supply through UN agencies to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection.

The WHO asked countries that received the vaccine to take appropriate actions, but did not specify what the appropriate actions would be. As per sources, WHO's suspension is not related to safety or efficacy issues but only limited to supply for UN agencies. 

Read Also: COVAXIN granted much-awaited WHO approval

Read Also: COVAXIN showed 77.8 per cent efficacy against symptomatic COVID-19: Lancet Study

No Impact on Efficacy

WHO clarified that Covaxin is effective and no safety concerns exist. The suspension of the vaccine's supply is in response to the outcomes of WHO's routine post-emergency use listing inspection that was conducted between March 14-22. The suspension of production for export will result in the interruption of the Covaxin supply. 

Bharat Biotech also clarified in a statement that there is no impact on efficacy and safety of the COVID-19 vaccine Covaxin. "For 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 Bharat Biotech. 

The company added saying that it is temporarily slowing down Covaxin production for facility optimisation, as it will focus on pending facility maintenance, process and facility optimisation activities.

Read Full Statement Below

WHO suspends COVAXIN's supply 

The World Health Organisation suspended Bharat Biotech's COVID-19 vaccine, Covaxin's supply through UN agencies. 

WHO said that there will be an interruption of supply of Covaxin due to suspension of production for export. 

WHO also noted that Bharat Biotech has committed to comply by addressing the GMP (good manufacturing practice) deficiencies and is developing a corrective and preventive action plan, for submission to the DCGI and WHO.

In the meantime, Bharat Biotech has decided to suspend production of Covaxin for export as a precautionary measure. 

Important Note: This does not effect or impact the effectiveness and safety of the Covaxin. 

Read Also: Bharat Biotech’s COVAXIN receives certificate of Good Manufacturing Practice from Hungarian authorities

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