Hyderabad based Bharat Biotech’s Covaxin has been found 65.2 per cent effective against Delta variant. Indian covid vaccine Covaxin’s phase III data has been reviewed and published in the medical journal The Lancet. The Lancet peer-review has confirmed the efficacy analysis which demonstrates Covaxin to be effective against covid.
” 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”, said the journal Lancet. The efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic Covid, 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 infection.
The 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.
Dr. Krishna Ella, CMD of 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”.
Covaxin has been found 63.6 per cent effective against asymptomatic Covid in phase III data. The Covaxin efficacy data demonstrates 70.8 per cent protection against all variants of SARS-CoV-2 virus. Covaxin was developed under a partnership with the Indian Council of Medical Research and the National Institute of Virology, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration. “The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world, added Dr Ella.
Dr. Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said,“Following successful isolation of the SARS-CoV-2 virus at ICMR -National Institute of Virology (NIV), Pune, ICMR and Bharat Biotech International Ltd (BBIL) embarked upon one of the most successful public-private partnership to develop the virus isolate into an effective COVID-19 vaccine. I am delighted to see that the phase III efficacy data has also been published in THE LANCET, one of the most reputed journals worldwide. This itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines. The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of “Atmanirbhar Bharat” along with the Indian academia and industry in fighting against the odds and carving a niche in the global community.”
Recently, the World Health Organization granted emergency use listing to the vaccine enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide. Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.
The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India’s largest ever clinical trial conducted for a Covid-19 vaccine. Covaxin is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results available during Q4 2021.