Covaxin vaccine (BBV152) 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 highly effective in preventing severe disease and hospitalization due to COVID-19.
No severe allergic reactions or anaphylaxis caused by BBV152 vaccine have been recorded in the context of clinical trials; however, rare cases of anaphylaxis have been reported following its use in national vaccination programmes.
The data reviewed by WHO support the conclusion that the known benefits of BBV152 vaccine outweigh the risks that are known or considered possible. Therefore, WHO recommends the use of BBV152 in those aged 18 years and older.
The supply of Covaxin (Bharat Biotech) through UN procurement agencies was suspended (as of 2 April 2022) 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.