Bharat Biotech claims Covaxin 81 per cent efficient in Phase 3 trials

Bharat Biotech on Wednesday said its COVID19 vaccine Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in Phase 3 clinical trialsThe process involved 25800 subjects the largest ever conducted in India in partnership with the Indian Council of Medical Research the Hyderabadbased firm said in a statementThe Phase 3 study enrolled participants between 1898 years of age including 2433 over the age of 60 and 4500 with comorbidities it addedThe first interim analysis is based on 43 cases of which 36 cases of COVID19 were observed in the placebo group versus 7 cases observed in the COVAXIN group resulting in a point estimate of vaccine efficacy of 806 per cent Bharat Biotech saidToday is an important milestone in vaccine discovery for science and our fight against coronavirus With todays results from our Phase 3 clinical trials we have now reported data on our COVID19 vaccine from Phase 1 2 and 3 trials involving around 27000 participants Bharat Biotech Chairman amp Managing Director Krishna Ella saidCovaxin demonstrates a high clinical efficacy trend against COVID19 but also significant immunogenicity against the rapidly emerging variants he addedOn Monday Prime Minister Narendra Modi was administered Covaxin on the very first day of expansion of the inoculation drive to cover people aged 60 and above and those between 4559 having comorbiditiesIn January Indias drugs regulator had approved Oxford COVID19 vaccine Covishield manufactured by the Serum Institute and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country paving the way for a massive inoculation driveCovishield had shown an efficacy rate of 70 per cent after two full doses However one of the regimens with a half dose and a full dose showed 90 per cent efficacy against the virusBharat Biotech said the interim analysis of its vaccine included a preliminary review of the safety database which showed that severe serious and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups the company saidThe trials conduct and monitoring are as per good clinical practice guidelines and have been outsourced to IQVIA it addedAnalysis from the National Institute of Virology indicates that vaccineinduced antibodies can neutralize the UK variant strains and other heterologous strains Bharat Biotech saidThe company expects to share further details of the trial results as additional data becomes available it notedAdditional interim analysis is planned for 87 cases and the final analysis is planned for 130 cases the company said All data from the second interim and final analyses will be shared via prepublication servers as well as submitted to a peerreviewed journal for publication it addedBharat Biotech said more than 40 countries globally have expressed their interest in CovaxinThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever