Hyderabad-based Bharat Biotech on Friday announced that the Lancet peer-review confirmed the efficacy analysis of Bharat Biotech’s Covaxin.
As per phase-three clinical trials data, Covaxin demonstrates 77.8 per cent efficacy against symptomatic COVID-19. “COVAXIN is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent,” the official statement issued by Bharat Biotech said citing the study by the Lancet.
“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,” said the company’s statement.
Further, it said that Covaxin will be 93.4 per cent effective against severe symptomatic COVID-19.
“Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events,” it said.
“Efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19, 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta and 70.8 per cent protection against all variants of SARS-CoV-2 virus,” Bharat Biotech added.
Dr Krishna Ella, Chairman and Managing Director (CMD) of Bharat Biotech said, “The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world,” he said.
“I am delighted to see that the phase III efficacy data has also been published in the Lancet. This itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines,” Dr Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said.
“The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of “Atmanirbhar Bharat” along with the Indian academia and industry in fighting against the odds and carving a niche in the global community,” Bhargava added.
Recently, the World Health Organization granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide, the statement added.