Phase 3 trials show Covaxin has 78% overall efficacy
Tribune News Service
New Delhi, July 3
Covaxin has been found to be 78 per cent effective against overall Covid-19 disease and 93 per cent against severe infections. Bharat Biotech today announced safety and efficacy analysis data from Phase 3 clinical trials of Covaxin, a whole virion inactivated vaccine against SARS-CoV2, developed in partnership with the ICMR-National Institute of Virology, Pune.
Announcing the summary of trials, Bharat Biotech said the vaccine significantly cut hospitalisation and showed potential to limit infection and transmission.
The analysis demonstrated 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. The efficacy was 93.4 per cent in severe symptomatic cases. Safety analysis demonstrated that adverse events were similar to placebo with 12 per cent of subjects experiencing commonly known side-effects and less than 0.5 per cent feeling serious adverse events.
“Covaxin demonstrated 63.6 per cent protection against asymptomatic Covid-19 and 65.2 per cent against the SARS-CoV-2, B.1.617.2 Delta variant,” Bharat Biotech chairman Krishna Ella said. “Covaxin was well tolerated and the Data Safety Monitoring Board has not reported any safety concern related to the vaccine. The overall rate of adverse events observed was lower than that seen in other Covid-19 vaccines. The safety profile of Covaxin is now well established, based on inactivated vaccines technology,” a company statement said.
Importantly, no licensed SARS-CoV-2 vaccine has so far reported efficacy against asymptomatic infection in a randomised controlled trial. Covaxin is the first to do so.
ICMR Director General Balram Bhargava said, “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.”
Bharat Biotech is undertaking additional clinical trials to establish Covaxin safety and efficacy for children aged 2 to 18 years. A trial to determine the safety and immunogenicity of a booster dose is also in process.
Performance card
- 93% effective in severe cases
- 65% against Delta variant
- 63% in asymptomatic cases
- 44,111 fresh cases
- Total deaths 4,01,050
- Active cases 4,95,533
- 738 deaths in 24 hours
Gathering norms eased in Himachal
Shimla: The Himachal Government has announced more relaxations in restrictions following decline in the positivity rate to 1.3 per cent. Now, a maximum of 250 persons can attend outdoor functions, while 150 persons can participate in functions held indoors.
