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The interim results of the Phase-3 trials for Covaxin have shown a clinical efficacy of 78% against mild, moderate and severe Covid-19 disease, makers Bharat Biotech and Indian Council of Medical Research (ICMR) said on Wednesday.
Balram Bhargava, secretary in department of health research and director-general of ICMR, said Covaxin worked well against most variants of SARS-CoV-2.
Covaxin’s efficacy against severe Covid-19 disease was 100% with an impact on reduction in hospitalisations while the efficacy against asymptomatic Covid-19 infection was 70%, the company said.
Covaxin was developed with seed strains from the National Institute of Virology and the Phase-3 clinical trials were co-funded by ICMR. Safety and efficacy results from the final analysis will be available in June and the final report will be submitted to a peer-reviewed publication.
The company has expanded capacity across multiple facilities in Hyderabad and Bengaluru to be able to produce 700 million doses a year.
The interim analysis was based on 87 symptomatic cases of Covid-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78%. The Phase-3 study enrolled 25,800 participants between 18 and 98 years of age, including 10% over the age of 60, with analysis conducted 14 days after the second dose.
Bharat Biotech CMD Krishna Ella said the efficacy against SARS-Cov-2 has been established and helped reduce hospitalisations in severe Covid-19 cases and reduced disease transmission in asymptomatic infections. Covaxin demonstrated safety in human clinical trials and in usage under emergency use, Ella added.
The company plans to conduct clinical trials in India and globally to evaluate its safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants, he said.
The vaccine developed by ICMR and Bharat Biotech was approved and introduced initially through Emergency Use Authorisation under the clinical trial mode.
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