Hyderabad: Bharat Biotech (BB), a global leader in vaccine development and innovation, on Wednesday announced that COVAXIN, India’s first indigenous Covid-19 vaccine, has been granted Emergency Use Listing by the World Health Organization (WHO).
This vaccine is a whole virion-inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV, Pune, Hyderabad based BB said in a statement here.
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics while adhering to stringent criteria of safety, efficacy and quality.
With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer COVAXIN®. Furthermore, UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure COVAXIN® for distribution to countries worldwide.
This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN.
As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification, he said.
The EUL authorisation for COVAXIN will enable us to contribute to accelerating the equitable access of COVID-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency, he added.