Bharat Biotech India Ltd (BBIL), the Hyderabad-headquartered biotech major, has brought out the much-awaited phase-III results of Covaxin that engaged about 25,800 volunteers in 25 hospitals in the country.
BBIL has said that Covaxin had shown 77.8% efficacy against symptomatic Covid cases. Developed in partnership with Pune’s National Insitute of Virology and Indian Council of Medical Research, Covaxin’s efficacy is higher than the AstraZeneca-developed Covishield as the latter’s reported efficacy is 70.4% in the phase-III trial as published in peer-reviewed medical journal Lancet. According to BBIL, Covaxin has also shown 65.2% efficacy against the Covid-19’s Delta variant, which was behind the spike in the Coronavirus cases in the country in April and May this year.
Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that innovation from India will now be available to protect global populations.”
Covaxin, according to the company, has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low – and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.
Prof (Dr) Balram Bhargava, Secretary, Department of Health Research, and Director General, Indian Council of Medical Research, said, “Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards. Covaxin will not only benefit the Indian citizens but would also immensely contribute to protecting the global community against the deadly SARS-CoV-2 virus. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena.
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “It is a momentous day for everyone, at Bharat Biotech, as we announce the final phase-III results of Covaxin and its efficacy of 77.8%. We wish to thank ICMR, NIV-Pune, Virovax, DSMB and Adjudication Committee. We especially thank our medical affairs team for leading the project, the technical and marketing teams who have relentlessly worked to complete the clinical trials and coordination of 25 sites across the country since May 2020.”
Prof (Dr) Priya Abraham, Director National Institute of Virology ICMR said, “The overall efficacy of 77.8 % following the phase-III clinical trial of Covaxin is wonderful news. ICMR-NIV and BBIL have had very fruitful interactions during this exhilarating journey. Sera from Covaxin recipients have also been evaluated against viral variants detected in India ie, the Alpha, Beta, Zeta, Kappa and Delta. The making of this vaccine entirely on Indian soil is a matter of great pride to every Indian.”
Covaxin has now received emergency use authorisations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc with EUA’s in process in 50 countries worldwide.