The BBV152 (Covaxin) vaccine against COVID-19 manufactured by Bharat Biotech is a whole virion inactivated SARS-CoV-2 vaccine that received WHO Emergency Use Listing (EUL) in December 2021 (with an update published on 15 March 2022).
The WHO EUL process evaluates the quality of manufacturing along with safety and efficacy of the vaccine. Like all other EUL vaccines, Covaxin COVID-19 vaccine is safe and highly effective in preventing severe disease and hospitalization due to COVID-19.
This vaccine is recommended for people aged 18 years and older.
The supply of Covaxin (Bharat Biotech) through UN procurement agencies remains suspended (as of January 2023) in response to the outcome of a WHO inspection on 14–22 March 2022, and due to the need to conduct process and facility upgrade to address identified deficiencies in good manufacturing practices (GMP).
The risk assessment at that time did not indicate changes in the risk–benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concerns exist.
Strategic Advisory Group of Experts on Immunization (SAGE) interim recommendations for use of COVID-19 vaccines: