Bharat Biotech, manufacturer of COVID-19 vaccine Covaxin, on July 3 announced the safety and efficacy analysis data from Phase-3 clinical trials of the vaccine.
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 second dose, conducted at 25 sites across India.
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 data demonstrates 63.6 per cent protection against asymptomatic COVID-19 and efficacy data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant.
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, US.
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 the vaccine was lower than that seen in other COVID-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 the vaccine from the governments,” the company said.
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.
Krishna Ella, chairman & managing director at 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 2-8 degree Celsius. 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.
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 per cent 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. The vaccine 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. The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena.”