After the World Health Organization suspended the COVid-19 vaccine COVAXIN from its COVAX facility, Hyderabad-based Bharat Biotech clarified on Sunday that there is “no impact on efficacy and safety of COVAXIN.”
The vaccine certificates supplied to millions of people who have received Covaxin are still valid because there is no influence on the vaccine’s efficacy and safety, according to a statement released by Bharat Biotech in response to the WHO’s suspension.
These improvements were indispensable as all current facilities had been regenerated for the manufacture of COVAXIN, with nonstop production for the past year to meet the public health emergency of Covid-19. During the COVID -19 pandemic, certain extremely complex equipment needed to improve process scarcity was unavailable. It should be emphasized that the quality of COVAXIN was never jeopardized, according to the statement.
The company also stated that they are working on more upgrades and improvements to ensure covaxin production satisfy the growing global regulatory requirements.
Despite this strong safety and efficacy record, Bharat Biotech is working diligently to make additional enhancements and modifications to ensure that COVAXIN production meets ever-changing global regulatory criteria. There can be no compromises in attaining operational excellence objectives as patient safety is the most important priority for any new vaccine. It stated further.
The World Health Organization (WHO) has suspended Bharat Biotech’s COVID-19 vaccine, COVAXIN, from its COVAX facility, according to the UN health organization on Saturday, citing production flaws.
WHO confirms the suspension of supply of COVAXIN produced by Bharat BIOTECH through UN procurement agencies and advises countries that have received the vaccine to take appropriate action. According to a statement from WHO.
However, the UN body stated that there will be no difficulties with a vaccine’s safety and efficacy.
To date, the risk-benefit ratio has not changed as a result of the risk assessment. The vaccination is efficacious, according to the data available to WHO, and there are no safety concerns. It states that countries should refer to the respective SAGE advice for continuing vaccination with other sources of COVID19 vaccines.
“During the recent WHO post-EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement actions and indicated that they will be implemented as soon as practicable,” Bharat Biotech said of the WHO inspection.
“It does not imply a change in the risk-benefit ratio (for COVAXIN), and the data available to WHO indicates that the vaccine is efficacious and that there are no safety concerns,” it stated.
This suspension came as a result of a WHO post-emergency use listing inspection that took place between March 14 and March 22. There would be an intervention in the supply of Covaxin for export following the suspension.
Publidhed By :- Shubham Agarwal
Edited by :- Khushi Thakur
