Covaxin shows 77.8 per cent overall efficacy, 65.2 per cent effective against Delta variant: Bharat Biotech
Bharat Biotech on Saturday released the results from the Phase 3 trials of Covaxin, claiming it demonstrated overall vaccine efficacy of 77.8 per cent against the coronavirus. The vaccine is 65.2 per cent 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.
Vaccine recorded an overall vaccine efficacy of 77·8 per cent
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.
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.
“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.
Highly efficacious against symptomatic and asymptomatic COVID-19 variant
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.
15 people died during the study, and as per the investigators, they were not linked to the vaccine or placebo.