Hyderabad, Jul 3 (UNI) Bharat Biotech, a global leader in vaccine development and innovation, announced on Saturday that the efficacy analysis demonstrated COVAXIN® to be 77.8 per cent 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 Hyderabad-based Vaccine Maker has concluded final analysis for COVAXIN® from phase-three clinical trails.
It said the 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.
In a statement, Bharat Bioteh said the Efficacy analysis demonstrates COVAXIN® to be 93.4% effective against severe symptomatic COVID-19, 63.6% protection against asymptomatic COVID-19 and 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.
The 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.
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 Covid-19 vaccines.
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,” he said.
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 highest international standards, he said.
COVAXIN® will not only benefit the Indian citizens but would also immensely contribute to protect 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', he added.
Ms. 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®, she added.
UNI CS 1239