No impact on Covaxin safety, clarifies Bharat Biotech after WHO suspension
"It does not indicate a change in risk-benefit ratio (for Covaxin) and the data, available to WHO, indicates the vaccine is effective and no safety concern exists," it said.
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New Delhi: Hyderabad-based Bharat Biotech on Sunday issued a clarification that there is "no impact on efficacy and safety of the COVID-19 vaccine COVAXIN" after the World Health Organisation suspended it from its Covax facility.
"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," read the statement issued by Bharat Biotech on suspension from WHO.
The vaccine manufacturer has further said that the company is slowing down the production of Covaxin for facility optimization.
"For the coming period the company will focus on pending facility maintenance, process and facility optimization activities," the statement read.
"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 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," it added.
The company also mentioned that they are working to 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 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," it said.
The Bharat Biotech's COVID-19 vaccine, COVAXIN has been suspended by World Health Organization (WHO) from its Covax facility, announced the UN health body on Saturday attributing it to deficiencies in manufacturing practices.
"WHO confirms 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," reads the WHO in a statement.
However, the UN body clarified that there will be no issues related to the safety and efficacy of a 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 COVID19 vaccines countries should refer to the respective SAGE recommendation," it read.
On inspection by WHO, Bharat biotech 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."
"It does not indicate a change in the risk-benefit ratio (for Covaxin) and the data, available to WHO, indicates the vaccine is effective and no safety concern exists," it said.
This suspension has been done after the WHO post-emergency use listing inspection that was conducted between March 14-22. After the suspension, there will be an interruption of supply of Covaxin production for export.
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