Bharat Biotech announces Covaxin phase III trial results: All you need to know – Times of India

NEW DELHI: Bharat Biotech’s homegrown Covid-19 vaccine has shown an interim vaccine efficacy of 81 per cent in late-stage clinical trials, the company announced on Wednesday.
Covaxin had been approved in January without late-stage efficacy data raising questions about the effectiveness of the indigenous vaccine. However, the release of phase 3 trial results could help counter vaccine-hesitancy.
Bharat Biotech has now reported data from all three phases of trials which the company said involved as many as 27,000 subjects, the largest Covid-19 vaccine trial conducted in India.
Dr Krishna Ella, chairman and MD, Bharat Biotech, said, “Covaxin has demonstrated a high clinical efficacy trend against Covid-19 and also significant immunogenicity against the rapidly emerging variants.”
Here are six things you need to know about Covaxin phase 3 trial results:
* 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 a confirmed symptomatic Covid-19 with onset at least 14 days after the second study vaccination in Covid-19 negative 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 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, a US-based clinical trial data analysis company.
* Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases.
India commenced its second phase of the Covid-19 vaccination drive to inoculate people above 60 years and those over 45 with comorbidities against the coronavirus from March 1.
The first phase of the Covid vaccination drive had started on January 16 with priority given to the healthcare workers and frontline workers.
Currently, India has permitted only two vaccines against Covid-19, Covaxin and Oxford-AstraZeneca’s Covishield vaccine.