Bharat Biotech on Wednesday released results of Phase 3 clinical trials of its coronavirus vaccine Covaxin, with the drug demonstrating 81 per cent interim efficacy against Covid-19.
“The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its phase III clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research (ICMR), the biotech company said in a release.
The company said the phase III study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with co-morbidities.
“The primary endpoint of phase III 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,” it stated.
Bharat Biotech further said 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,”
The company added that the analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.