Bharat Biotech today announced that the safety and efficacy analysis data from phase-III clinical trials of Covaxin is peer-reviewed and published in The Lancet, the company said in a statement.
The Lancet peer-review confirms the efficacy analysis which demonstrates Covaxin to be effective against COVID-19, it added.
Speaking in this regard, 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.
He added, “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 statement added that the phase-III 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.
It also said that 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 the successful isolation of the SARS-CoV-2 virus at ICMR -National Institute of Virology (NIV), Pune, ICMR and Bharat Biotech 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. This itself speaks high about the strong position of Covaxin amongst other global front-runner 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.”