Hyderabad-based pharmaceutical company, Bharat Biotech will rectify the issues raised by the World Health Organization regarding its COVID-19 vaccine-- Covaxin-- in a few days and added that the company has informed about this development to the Drugs Controller General of India (DCGI) and Union Health Ministry, sources said on Monday.
According to sources close to ANI," 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.
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 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.
Sources further said that they 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."
Bharat Biotech has further said that the company is slowing down the Covaxin production for facility optimization and the company will focus on pending facility maintenance, process and facility optimization activities.
"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.
The company has also mentioned that they are working for further improvements and 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.
The Hyderabad-based Bharat Biotech's 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.
The WHO is today confirming the suspension of supply of Covaxin produced by Bharat Biotech through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate," the WHO stated in their recent statement.
However, the UN body has clarified that there will be no issues related to the safety and efficacy of the vaccine.
"The risk assessment to date does not indicate a change in the risk-benefit ratio. The data available to WHO, indicate the vaccine is effective and no safety concern exists. For continuation of vaccination with alternative sources of COVID-19 vaccines, countries should refer to the respective Strategic Advisory Group of Experts on Immunization (SAGE) recommendation," WHO said.
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-March 22.