Bharat Biotech, a global leader in vaccine development and innovation, announced today safety and efficacy analysis data from Phase III clinical trials of COVAXIN® to be 77.8 percent effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.
Bharat Biotech Concludes Final Analysis for COVAXIN® Efficacy from Phase 3 Clinical Trials.Announced today safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, a whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with ICMR and NIV Pune.
Phase 3 clinical trials of COVAXIN® was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India. COVAXIN® is formulated with a novel Algel+IMDG adjuvant. IMDG is a TLR7/8 agonist known to induce memory T cell responses along with strong neutralizing antibodies. The activation of cell-mediated immune responses is especially valuable in a multi-epitope vaccine such as COVAXIN®, where immune protection can be achieved from S, RBD, and N proteins alike. IMDG was developed under a partnership between Virovax and NIAID, National Institutes of Health USA.
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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 other corvid-19 vaccines. The safety profile of COVAXIN® is now well established based on inactivated vaccines technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech’s vero cell manufacturing platform. Furthermore, Bharat Biotech has so far not sought indemnity for COVAXIN® from the Governments.
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® 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 & Director General Indian Council of Medical Research, said, “I am delighted to note that COVAXIN®, developed by ICMR and BBIL under an effective public-private partnership, has demonstrated an overall efficacy of 77.8% in India’s largest COVID phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards.
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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. I am also pleased to see that COVAXIN® works well against all variant strains of SARS-CoV-2. 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-3 Results of COVAXIN®️ and its efficacy of 77.8%. We wish to thank ICMR, NIV-Pune, Virovax, DSMB, and Adjudication Committee. We earnestly thank our clinical trial sites, Principle Investigators, IQVIA, and every participant who has reposed their faith in COVAXIN®.
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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 i.e., 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”.
SOURCE-NSS
