Bharat Biotech announces phase 3 results of Covaxin, demonstrates interim clinical efficacy of 81%

  • | Wednesday | 3rd March, 2021

Bharat Biotech, developing vaccines for infectious diseases, announced the first interim analysis of its BBV152 (Covaxin), on Wednesday. The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.     

Interim Phase 3 Results: 81% Efficacy

The phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.   

The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus seven cases observed in the BBV152 (Covaxin) group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.    

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial`s conduct and monitoring are as per good clinical practice guidelines and have been outsourced to IQVIA.  

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains, which has been published in bioRxiv.

Bharat Biotech expects to share further details of the trial results as additional data become available. Additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.   


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