CONFIDENCE BOOSTER! Covaxin 93.4% effective against severe symptomatic COVID-19 cases, 65.2% against new Delta variant, says Bharat Biotech
Bharat Biotech has released safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, a whole virion inactivated vaccine against SARS-CoV2.
Bharat Biotech has released safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, a whole virion inactivated vaccine against SARS-CoV2. As per Bharat Biotech Phase III clinical trials data, the efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19 cases. Covaxin also demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant, showed the Bharat Biotech's research.
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The company on Saturday said it concluded the final analysis of Covaxin efficacyfrom Phase3 trials.
"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. We are proud to state that Innovation from India will now be available to protect global populations," said Krishna Ella, Chairman and Managing Director of Bharat Biotech in the research paper put up by the pharma company.
The efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19, a release from the city-based vaccine maker said.
Also, safety analysis showed adverse events reported 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.
Phase 3 clinical trials of the vaccine was an event driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across India.
The whole virion inactivated vaccine against SARS-CoV2, was developed inpartnership with Indian Council of Medical Research and National Institute ofVirology in Pune.
Director General of ICMR, Balram Bhargava said, "I am delighted to note that Covaxin developed by ICMR and BBIL under an effective public private partnership, has demonstrated an overall efficacy of 77.8 per cent in Indias largest COVID phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of highest international standards."
The Phase 3 trials were conducted between November 16, 2020 and January 7, 2021 with 25,798 participants who were randomised to BBV152 or placebo groups.
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