Bharat Biotech’s evaluation was done on 130 confirmed cases, with 24 observed in the vaccine group, compared to 106 in the placebo group. “Safety analysis demonstrated adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events," the company said. “Efficacy data demonstrated 63.6% protection against asymptomatic covid, 65.2% protection against SARS-CoV-2, B.1.617.2 Delta and 70.8% protection against all variants of SARS-CoV-2 virus," it said.
Covaxin has been developed under a partnership between the Indian Council of Medical Research (ICMR) and the National Institute of Virology, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration.
“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. The phase 3 trial efficacy and safety study, involving 25,800 volunteers across 25 sites, is India’s largest-ever clinical trial conducted for a covid-19 vaccine," Dr Krishna Ella, chairman and managing director, Bharat Biotech, said in a statement.
The drugmaker said 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, it said.
“Following successful isolation of the SARS-CoV-2 virus at ICMR - NIV, Pune, ICMR and Bharat Biotech embarked on one of the most successful public-private partnerships to develop the virus isolate into an effective covid-19 vaccine," said Dr. Balram Bhargava, director general, ICMR.
Earlier this month, the World Health Organization granted emergency use listing to Covaxin, allowing countries to expedite their regulatory approvals to import and administer doses. It also received emergency use authorizations in several countries, with applications under process in over 50 countries. Bharat Biotech has partnered with US-based Ocugen to seek approvals for Covaxin in the US and Canada.
So far, the company has supplied more than 150 million doses of Covaxin globally. The vaccine is also being evaluated in controlled clinical trials in children 2-18 years of age, with results set to become available later this quarter. Bharat Biotech is also poised to achieve its goal of an annualized capacity of 1 billion doses of Covaxin by this year-end, it said.
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