New Delhi, April 4: The World Health Organization's (WHO) suspension of supplies of Covid-19 vaccine Covaxin of the Bharat Biotech supply is not related to safety or efficacy issues but only to supply for United Nations agencies, sources said.
"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 EUL inspection) a routine inspection for Covaxin," sources added.
As per the sources, the WHO suspension of the Covaxin supply is only for the UN agencies.
"We are now only doing direct supplies to other countries and nine others under 'Vaccine Maitri'," sources said. They further added that the suspension of supply would not impact the vaccine supply of Covaxin. "We intend to apply for full licensure for Covaxin from the WHO," the Bharat Biotech source said.
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The sources further said they had not 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."
Bharat Biotech has further said the company was slowing down the Covaxin production for facility optimisation and the company would focus on pending facility maintenance, process and facility optimisation activities.
"As all existing facilities were repurposed 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 were required to enhance the process stringency were 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.
The company has also mentioned that they are working for further improvements and upgrates to ensure that the production of Covaxin continues to meet the increasing global regulatory requirements.
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Hyderabad-based Bharat Biotech's anti-Covid Vaccine, Covaxin, has been suspended by WHO under the Covax facility, announced the UN health body on Saturday, attributing it to deficiencies in manufacturing practices. However, the UN body has clarified that there will be no issues related to the safety and efficacy of the vaccine.
On inspection by WHO, Bharat Biotech has said, "During the recent WHO post-EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical."
This suspension has been done after the WHO post-emergency use listing inspection that was conducted between March 14-22.
-PTC News