Covaxin has overall vaccine efficacy of 77.8%, claims Bharat Biotech in results from Phase 3 trials

Covaxin showed 65.2% protection against the Delta variant (B.1.617.2) of COVID-19.

New Delhi: The Bharat Biotech on Saturday (July 3, 2021) released the results from the Phase 3 trials of Covaxin and claimed that it demonstrates overall vaccine efficacy of 77.8%.

The Hyderabad-based company said that the Covaxin has been proven 'safe' in India's largest efficacy trial and shared the final Phase-3 Pre-Print data published on medRxiv.

Over 25,798 participants were recruited between November 16, 2020, and January 7, 2021, and were randomised to Covaxin or placebo groups, of which, 24,419 received two doses of the vaccine. 

In a case-driven analysis, 130 cases of symptomatic COVID-19 were reported in 16,973 (0.77%) participants with follow-up at least two weeks after the second vaccination, whereas, 24 occurred in the vaccine group and 106 in placebo recipients giving an overall vaccine efficacy of 77.8%. 

Sixteen cases, one vaccinee and 15 placebo recipients met the severe symptomatic COVID-19 case definition giving a vaccine efficacy of 93.4%. 

On the other hand, the data stated that the efficacy against asymptomatic COVID-19 was 63.6%. 

Covaxin conferred 65.2% protection against the Delta variant (B.1.617.2) of COVID-19. 

"Covaxin was well tolerated with no clinically or statistically significant differences in the distributions of solicited, unsolicited, or serious adverse events between vaccine and placebo groups. No cases of anaphylaxis or vaccine-related deaths were reported," the data said. 

A double-blind, randomised, multicentre, phase 3 clinical trial was done in 25 Indian hospitals to evaluate the efficacy, safety, and immunological lot consistency of Covaxin. 

The work was funded by Bharat Biotech International Limited and co-funded by the Indian Council of Medical Research (ICMR).

Dr Krishna Ella, Chairman & 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."

He added, "We are proud to state that innovation from India will now be available to protect global populations."

Prof Balram Bhargava, Secretary Department of Health Research & Director General ICMR, said, "I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena."