Bharat Biotech on Saturday claimed that Covaxin showed 77.8 percent efficacy in phase 3 trials against COVID-19. The vaccine is 65.2 percent effective against the Delta Variant.
The Hyderabad-based multinational biotechnology company shared the final Phase-3 data published on medRxiv, saying Covaxin has been proven ‘safe’ in India’s largest efficacy trial.
Bharat Biotech conducted a double-blind, randomised, multicentre, phase 3 clinical trial in 25 Indian hospitals to evaluate the vaccine’s efficacy, safety, and immunological lot consistency.
Over 25,798 participants were recruited between November 16, 2020, and January 7, 2021, and were randomized to Covaxin or placebo groups, of which 24,419 received two doses of the vaccine, reported Times Now.
The vaccine recorded an overall vaccine efficacy of 77·8 per cent, 93.4 per cent against severe symptomatic cases, and 65.2 per cent protection against the SARS-CoV-2 ‘Variant of Concern’, B.1.617.2 (Delta) and efficacy against asymptomatic COVID-19 was 63.6 per cent, the report said.
“No cases of anaphylaxis or vaccine-related deaths were reported. Interpretation: BBV152 was immunogenic and highly efficacious against symptomatic and asymptomatic COVID 19 variant associated disease, particularly against severe disease in adults,” it said.
Vaccination was well tolerated, with an overall incidence of adverse events observed over a median of 146 days lower than that observed with other COVID-19 vaccines.
After releasing the phase 3 data, Dr Krishna Ella, Managing Director, Bharat Biotech, said that successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever COVID vaccine trials in India establishes the ability of the country and developing world countries in innovation.
The vaccine was immunogenic and highly efficacious against symptomatic and asymptomatic COVID-19 variant associated disease, particularly against severe disease in adults, Bharat Biotech said.