Hyderabad: Bharat Biotech, a global leader in vaccine development and innovation, announced on Saturday 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.
The vaccine maker claimed that the efficacy analysis demonstrates 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.
It said Efficacy analysis demonstrates COVAXIN® to be 93.4% effective against severe symptomatic
COVID-19 and Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling
serious adverse events
The biotechnology company said Efficacy data demonstrates 63.6% protection against asymptomatic COVID-19 and Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.
Bharat Biotech in a statement said 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.
It said 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 partnership between Virovax and NIAID, National Institutes of Health USA, the Company added.
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 otherCovid-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.
No licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR testing.
COVAXIN® is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission, the company added.