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Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN®; Demonstrates overall Interim Clinical Efficacy of 78% and 100% efficacy against Severe COVID-19 disease

Globally recognized biotechnology innovator and distributor, Bharat Biotech, along with CMR, has announced promising Phase 3 trial Interim Results for COVAXIN®. Analysis based on a study that enrolled 25,800 participants between the ages of 18 and 98, of which 10% were over the age of 60, showed 78% Interim Clinical Efficacy. 100% efficacy was recorded against severe COVID-19 cases, and 70% against asymptomatic infection.
Results from the final analysis will be available in June and the final report will be submitted
to a peer-reviewed publication.

“COVAXIN® has demonstrated an excellent safety record in human clinical trials and usage under emergency use. COVAXIN® is now a global innovator vaccine derived from Research & Development from India. The efficacy data against severe COVID-19 and asymptomatic infections are highly significant, as this helps reduce hospitalizations and disease transmission, respectively,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

Development of the vaccine using seed strains from the National Institute of Virology and co-funding from the Indian Council of Medical Research makes it a true public-private partnership towards public health. Vaccine protocols have been tried and tested, aligning with the requirements of WHO, Indian, and other regulatory authorities, and have delivered consistent results over 15 years and more than 300 million doses supplied globally. Prof. Balram Bhargava, Secretary Dept. of Health Research & Director General of ICMR, expressed his pride and pleasure, noting that “COVAXIN® performs against most variants of SARS-CoV-2.”

The findings and robust real-life safety data-position COVAXIN® in the global vaccine landscape and several million doses have been safely supplied and administered in India and abroad. Further local and global trials by the biotech leader will continue to evaluate the vaccine’s safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants.

Over 60 countries have expressed their interest in COVAXIN®, being highly satisfied by the inactivated vaccine technology and robust data package. Several have also issued Emergency Use Authorizations. Facilities in Hyderabad and Bangalore are geared to reach a capacity of about 700 million doses/year, one of the largest for inactivated viral vaccines worldwide.
Joint Managing Director of Bharat Biotech, Mrs. Suchitra Ella, said, “COVAXIN®’s evidence-based development has proved its suitability for global access, with excellent efficacy results against symptomatic, asymptomatic, and severe disease. The interest from countries worldwide has quietly validated our efforts. We thank our Volunteers, Principal
Investigators, Partners, and team Bharat Biotech for their contribution to this project towards improving Global Public Health.”

About Bharat Biotech Located in Genome Valley, Hyderabad, is a leader in vaccine innovation, bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. The company has amassed an excellent track record and portfolio of vaccines and patents globally and is committed to international social innovation programs and public-private partnerships. Further information on Bharat Biotech can be found at
www.bharatbiotech.com.

(Source: Bharat Biotech, 2021)