Vaccine

WHO suspends India’s Covaxin supply through UN procurement agencies

Recommends countries which received the jab to take appropriate actions
Covaxin. PHOTO: EPA-EFE

The World Health Organization (WHO) has suspended the supply of India's first indigenous Covid-19 vaccine Covaxin, through UN procurement agencies, and recommended to countries which received the jab to take actions as appropriate.

There will be interruption of supply of Covaxin, produced by Hyderabad-based Bharat Biotech, due to suspension of production for export, WHO said in a statement, reports our New Delhi correspondent.

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, it said.

The WHO statement on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14 and 22 this year and the need to conduct process and facility upgrade to address recently identified good manufacturing practice (GMP) deficiencies.

Bharat Biotech officials could not be reached immediately for a response.

On April 1, Bharat Biotech announced a temporary slowing down of production of Covaxin across its manufacturing facilities in India, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.

During the recent inspection by a WHO team, Bharat Biotech agreed with 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 Drugs Controller General of India (DCGI) and WHO.

In the interregnum 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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WHO suspends India’s Covaxin supply through UN procurement agencies

Recommends countries which received the jab to take appropriate actions
Covaxin. PHOTO: EPA-EFE

The World Health Organization (WHO) has suspended the supply of India's first indigenous Covid-19 vaccine Covaxin, through UN procurement agencies, and recommended to countries which received the jab to take actions as appropriate.

There will be interruption of supply of Covaxin, produced by Hyderabad-based Bharat Biotech, due to suspension of production for export, WHO said in a statement, reports our New Delhi correspondent.

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, it said.

The WHO statement on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14 and 22 this year and the need to conduct process and facility upgrade to address recently identified good manufacturing practice (GMP) deficiencies.

Bharat Biotech officials could not be reached immediately for a response.

On April 1, Bharat Biotech announced a temporary slowing down of production of Covaxin across its manufacturing facilities in India, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.

During the recent inspection by a WHO team, Bharat Biotech agreed with 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 Drugs Controller General of India (DCGI) and WHO.

In the interregnum 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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