No safety concerns, says Bharat Biotech after final analysis for Covaxin efficacy

Bharat Biotech on Saturday announced safety and efficacy analysis data from Phase III clinical trials of Covaxin, a whole virion inactivated vaccine against SARS-CoV2 which was developed in partnership with ICMR and NIV Pune.

Phase 3 clinical trials of Covaxin were conducted on 130 symptomatic Covid-19 cases, reported at least two weeks after the 2nd dose, at 25 sites across India.

“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. 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,” an official statement released today has 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, said the statement.

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 vaccine 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 population.”

The firm said that the vaccine 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.

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 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 the highest international standards. 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.”