No impact on efficacy and safety of Covaxin, says Bharat Biotech after WHO suspension

No impact on efficacy and safety of Covaxin says Bharat Biotech after WHO suspension

Following the World Health Organization’s suspension of the COVID-19 vaccine COVAXIN from its Covax facility, Hyderabad-based Bharat Biotech released a clarification on Sunday stating that there is “no impact on the efficacy and safety of the COVID-19 vaccine COVAXIN.” “For the millions who have received COVAXIN, the vaccination certificates provided remain valid since there is no influence on the efficacy and safety of the vaccine,” Bharat Biotech said in response to the WHO suspension.

The vaccine producer has also stated that the corporation is slowing down Covaxin manufacturing in order to optimize the facility.

According to the statement, “For the foreseeable future, the business will prioritize pending facility maintenance, process, and facility optimization initiatives.”

“These modifications were overdue since all existing facilities had been repurposed for the manufacture of COVAXIN, with continuous production throughout the previous year to meet the public health emergency of COVID-19. During the COVID-19 epidemic, certain extremely complex technologies needed to improve process stringency were unavailable. It should be noted that the quality of COVAXIN was never jeopardized at any point in time, “it was added

The business also stated that they are working on additional enhancements and updates to guarantee that COVAXIN manufacturing continues to fulfill the growing worldwide regulatory standards.

Despite this strong safety and efficacy record, Bharat Biotech is working hard to make additional enhancements and modifications to guarantee that COVAXIN manufacturing meets ever-increasing worldwide regulatory criteria. Because patient safety is the most important priority for every new vaccination, there can be no compromises when it comes to fulfilling operational excellence goals, “it stated.

The World Health Organization (WHO) has stopped Bharat Biotech’s COVID-19 vaccine, COVAXIN, from its Covax facility, the UN health organization stated on Saturday, citing inadequacies in manufacturing processes.

The WHO confirmed the suspension of the supply of COVAXIN made by Bharat Biotech through UN procurement agencies and recommended that countries that received the vaccine take necessary steps, the WHO said in a statement.

However, the UN organization stressed that there will be no difficulties with a vaccine’s safety and efficacy.

To date, there has been no change in the risk-benefit ratio based on the risk assessment. The data are available to the WHO suggests that the vaccination is efficacious and that there are no safety concerns. Countries should refer to the respective SAGE guidelines for the continuation of immunization with alternate sources of COVID-19 vaccines. ” It was written.

During the recent WHO post-EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the proposed improvement actions and indicated that they would be implemented as soon as practicable, Bharat Biotech said.

“It does not imply a change in the risk-benefit ratio (for COVAXIN), and the evidence available to WHO confirms that the vaccine is efficacious and there are no safety concerns,” it stated.

This suspension came as a result of the WHO post-emergency use listing examination, which took place between March 14 and March 22. Following the suspension, there will be a disruption in the supply of Covaxin for export.

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