Bharat Biotech jab shows 100% efficacy against severe COVID-19
pharmafile | April 22, 2021 | News story | | COVID-19, India
Indian biopharma company, Bharat Biotech, has reported interim analysis results from the Phase III trial of its COVID-19 vaccine, Covaxin, showed 100% efficacy against severe SARS-CoV-2 infection, with an overall efficacy of 78%.
Covaxin has also shown 70% efficacy against asymptomatic infections, suggesting it will help prevent transmission.
The Phase III study involved 25,800 subjects between the ages of 18 to 98, with 10% of participants over the age of 60.
The second interim analysis is based on accruing 87 symptomatic COVID-19 cases. However, owing to the current surge in cases in India, 127 symptomatic cases were reported, providing an overall point estimate of vaccine efficacy of 78% against mild, moderate, and severe disease.
Bharat Biotech Chairman and Managing Director, Dr Krishna Ella, said: “Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use.
“The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively.”
The company is currently in the process of ramping up its vaccine production capacity to 700 million doses annually, and is pursuing approval for its candidate in 60 countries. In Mexico, the Philippines, and Iran, it is already fetching around $15-20 per shot.
Balram Bhargava, secretary, Department of Health Research and Director General of the Indian Council of Medical Research, said: “The first indigenous vaccine has shown the efficacy of 78% in the second interim analysis. I am also happy to note that Covaxin works well against most variants of SARS-CoV-2. These findings together consolidate the position of our indigenous vaccine in the global vaccine landscape.”
Bharat Biotech intends to expand Covaxin’s development with clinical trials planned in India and globally to assess its safety and immunogenicity in paediatric patients, the impact of booster doses of the vaccine, as well as its protection against known SARS-CoV-2 variants.
In February, All India Institute of Medical Sciences estimated that Covaxin could provide immunity against COVID-19 for nine to 12 months, as per the mathematical calculations.
Safety and efficacy results from the final analysis of the Phase III study will be available in June, following which the final report will be submitted to a peer-reviewed publication.
Kat Jenkins
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