Bharat Biotech to rectify issues in 15-20 days after WHO suspended Covaxin supply

New Delhi, Apr 5: Bharat Biotech is working on rectifying the issues raised by the World Health Organization to upgrade facilities and address deficiencies found in an inspection. The company has communicated to the WHO about this development to the Drugs Controller General of India (DCGI) and the Union Health Ministry, sources informed ANI on Monday.

A few days ago, the World Health Organization suspended the supply of Covaxin through United Nations agencies, asking the manufacturer to upgrade facilities and address deficiencies.

Bharat Biotech has informed Union Health Ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organization (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies," sources said to ANI.

"Received some feedback... will do those modifications. WHO has said nothing related to safety or efficacy," sources in Bharat Biotech told ANI. "It's (WHO post-'Emergency Use Authorization' inspection) a routine inspection for Covaxin," sources added.

Sources told the news agency that the suspension on the supply is only for the UN agencies and the company is doing direct supplies to other nations and nine others under 'Vaccine Maitri.' The latest development will not impact the vaccine supply of Covaxin. "We intend to apply for full licensure for Covaxin from the WHO," the Bharat Biotech source said.

However, the company, as per the sources, haven't received a final copy of the official report from the WHO yet, and "once we will receive the report, we will reply to it". Recently, in a statement on WHO's suspension of Covaxin, Bharat Biotech said, "For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine."

"As all existing facilities were re-purposed for the manufacture of Covaxin, with continuous production during the past year, to meet the public health emergency of COVID-19, these upgrades were due. Certain highly sophisticated equipment, which was required to enhance the process stringency, was unavailable during the COVID-19 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time," the company sources said

They further stated that the company is working on upgrades to ensure that the production of Covaxin continues to meet the increasing global regulatory requirements. "Notwithstanding this excellent safety and efficacy record, Bharat Biotech is diligently working to further improvements and upgrades to ensure that the production of Covaxin continues to meet the ever increasing global regulatory requirements. Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives," the company added.