Bharat Biotech announced today 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%. 

 Efficacy analysis demonstrates Covaxin to be 77.8% 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% effective against severe symptomatic Covid-19.

Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events. Efficacy data demonstrates 63.6% protection against asymptomatic Covid-19. Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta and finally the efficacy data demonstrates 70.8% 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.

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.

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. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, Indian Council of Medical Research, National Institute of Virology, and the trust imposed by our trial participants who made this happen.”

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 was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine.  The overall rate of adverse events observed in Covaxin was lower than that seen in Covid-19 vaccines. The safety profile of Covaxin is now well established based on inactivated vaccines technology, and in large part due to the extensive 25-year safety track record of Bharat Biotech’s vero cell manufacturing platform. 

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 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