Covaxin, the home-grown anti-COVID vaccine manufactured by Bharat Biotech, is 77.8 per cent effective against the virus, the manufacturer said citing data from the third phase of clinical trials.
According to data, which is yet to be peer-reviewed, the vaccine offers “65.2 per cent protection” against the rapidly emerging Delta variant. It was also found to be “93.4 per cent effective” against severe symptomatic COVID-19, the company said.
“We are proud to put India on the global map with scientific conviction, competence and commitment. Covaxin scores 10 world-class publications endorsing innovation, clinical research, data, safety, efficacy. Thank collaborators & Positive BB teamwork enduring a pandemic (sic),” Bharat Biotech co-founder Suchitra Ella said in a tweet.
The Phase 3 clinical trial was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India.
The company said no licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection and that will help in reducing disease transmission.
In a statement, the vaccine manufacturer said: “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.”
“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,” it said.
Dr Krishna Ella, Chairman and 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.”
Covaxin has received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico. The company is in discussions with WHO to obtain an emergency use listing for Covaxin. The product has been exported to several countries with additional requests for supplies being received.