New Delhi: Citing data from its third phase of clinical trials, Bharat Biotech in a statement issued on Saturday said that its Covaxin shows an overall 77.8 per cent efficacy against symptomatic Covid infections. The data, however, is yet to be peer-reviewed.
According to the vaccine maker, Covaxin offers 65.2 per cent protection against the rapidly emerging Delta variant.
The vaccine was also found to be "93.4 per cent effective" against severe symptomatic COVID-19.
Covaxin is a whole virus inactivated vaccine against SARS-CoV2, developed by Bharat Biotech in partnership with ICMR and NIV Pune.
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 pointed out that no licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection and that will help in reducing disease transmission.
"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 late-night tweet.
Phase 3 clinical trials were conducted on 130 symptomatic Covid patients between 18-98 years of age at 25 sites across India. Twelve per cent of the subjects experienced commonly known side effects and less than 0.5 per cent of subjects reported serious adverse events, Bharat Biotech, which developed the vaccine in partnership with ICMR and NIV Pune, said, adding that the overall rate of adverse events was lower than that seen in other COVID-19 vaccines.
The company added that that 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, it said that Bharat Biotech has so far not sought indemnity for Covaxin from the governments.
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 vaccines 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 the global population."
Covaxin has received emergency use authorizations in 16 countries including, Brazil, India, the 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.