"No safety concerns, says Bharat Biotech after final analysis for Covaxin efficacy"
Bharat Biotech on Saturday announced safety and efficiency analysis data from Phase III clinical trials of Covaxin, a whole virus inactivated vaccine against SARS-CoV2 which was developed in partnership with ICMR and NIV Pune.
Phase III 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 submitted any safety concerns related to the vaccine. The overall rate of adverse events observed in Covaxin was lower than that seen in other Coronavirus 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 production platform. Furthermore, Bharat Biotech has so far not sought indemnity for Covaxin from the Governments,” an official statement released today has mentioned.
No licensed SARS-CoV-2 vaccine has reported efficiency 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 spread, said the statement.
The firm said that the vaccine has been specifically designed to meet the needs of global vaccine 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 to 8ºC. It is also formulated to stick to a multi-dose vial policy, thereby reducing open vial wastage of vaccines, saving money to procurement agencies and governments alike.
Dr Balram Bhargava, Secretary Department of Health Research & Director General ICMR, said, “I am delighted to note that Covaxin, developed by ICMR and BBIL under an effective public-private partnership, has demonsttat an overall efficiency of 77.8 per cent in India’s largest COVID phase III clinical trial thus far. Indian 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 in protecting the global community against the deadly COVID-19 virus.”