Bharat Biotech has announced that the safety and efficacy analysis data from Phase III clinical trials of COVAXIN is peer-reviewed and published in The Lancet.

The Lancet peer-review confirms the efficacy analysis which demonstrates COVAXIN to be effective against COVID-19. COVAXIN is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent.  

Efficacy analysis demonstrates COVAXIN to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. The efficacy analysis demonstrates COVAXIN to be 93.4 per cent effective against severe symptomatic COVID-19.

Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events. The efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19. The efficacy data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta. The efficacy data demonstrates 70.8 per cent protection against all variants of SARS-CoV-2 virus.

Dr Krishna Ella, CMD, Bharat Biotech, said, “The peer-review of COVAXIN phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world-leading medical journals."