Hours after Drugs Controller General of India (DCGI) approved restricted use in an emergency situation to Bharat Biotech`s COVID-19 vaccine, Indian Council of Medical Research (ICMR) on Sunday said data generated through pre-clinical studies and various phases of clinical trial shows COVAXIN is `safe.
`”Data generated through pre-clinical studies and various phases of the clinical trial from within India highlighted COVAXIN`s safety and immunogenicity. Potential of COVAXIN to mount a resistance against new mutants of SARS-CoV-2, the virus causing COVID-19, informed the decision making process for vaccine approval,” ICMR tweeted.
Notably, COVAXIN is an indigenously developed coronavirus vaccine manufactured by Bharat Biotech in collaboration with the ICMR.
Earlier today, COVID-19 vaccines of Serum Institute of India and Bharat Biotech were granted permission for restricted use in an emergency situation by the Drugs Controller General of India (DCGI).