COVAXIN, India’s first indigenous Covid-19 vaccine, has been granted Emergency Use Listing (EUL ) by the World Health Organization. The maker of this vaccine is Bharat Biotech. This vaccine is a whole virion-inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV, Pune.
The emergency use listing 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, more countries can now expedite their regulatory approval processes to import and administer COVAXIN to their citizens. Furthermore, UNICEF, Pan-American Health Organization (PAHO) and GAVI COVAX facility will all be able to procure COVAXIN for distribution to countries worldwide.
Phase three trial data for COVAXIN was available in June 2021. The World Health Organisation Emergency Use Listing process commenced on July 6, 2021, with rolling data submission. The Strategic Advisory Group of Experts on Immunization of WHO had reviewed COVAXIN data on October 5 in a meeting and granted EUL today. It has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC.
COVAXIN has been tested through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12 peer-reviewed journals and available for review in the public domain.
