Covaxin Overall 77.8% Effective, Claims Bharat Biotech In Phase 3 Data

Bharat Biotech's Covaxin is overall 77.8 per cent effective against Covid, the vaccine maker said today in a statement, citing the data from the third phase of clinical trials. The data, however, is yet to be peer-reviewed.

The vaccine offers "65.2 per cent protection", it said, 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.

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.

In a statement, the vaccine maker further 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."

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 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 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 global population."

"The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena," Prof. (Dr) Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, said.

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.

Located in Genome Valley in Hyderabad, Bharat Biotech has delivered more than 4 billion doses of vaccines worldwide. The company has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC®), Rabies, Chikungunya, Zika, Cholera, and the world's first tetanus-toxoid conjugated vaccine for Typhoid.