● Efficacy analysis demonstrates COVAXIN® to be 77.8% effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group
● Efficacy analysis demonstrates COVAXIN® to be 93.4% effective against severe symptomatic COVID-19
● Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events
● Efficacy data demonstrates 63.6% protection against asymptomatic COVID-19
● Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant
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.”