COVAXIN works against double mutant; reduces hospitalisation, shows Phase 3 interim data

Shows 78 to 100 per cent efficacy against severe COVID disease; effective against UK, Brazil strains

COVAXIN works against double mutant; reduces hospitalisation, shows Phase 3 interim data

The second interim analysis is based on more than 87 symptomatic cases of COVID-19.

Aditi Tandon
Tribune News Service
New Delhi, April 21

In a major boost to made in India Covid vaccine enterprise, indigenous shot COVAXIN has been shown to successfully neutralise the double mutant detected in certain parts of India and the world.

The Indian Council of Medical Research lab National Institute of Virology announced the development today saying the Bharat Biotech-ICMR made COVID vaccine was effective against multiple strains of the SARS-Cov2 virus.

The ICMR had earlier isolated UK and Brazil strains and shown COVAXIN was effective against these.

The results of COVAXIN working against the double mutant were announced on Friday simultaneous to another major research declaration that reveals COVAXIN has 78 to 100 pc efficacy against severe COVID disease.

Bharat Biotech and ICMR today jointly shared the interim results from Phase 3 trials of COVAXIN saying these “demonstrate overall interim clinical efficacy of 78 pc and 100 pc efficacy against severe COVID-19 disease”.

The second interim analysis is based on more than 87 symptomatic cases of COVID-19.

The firm said due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 pc against mild, moderate, and severe COVID-19 disease.

“The efficacy against severe COVID-19 disease was 100 pc with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70 pc, suggesting decreased transmission in COVAXIN recipients,” the results said.

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, ICMR and Bharat Biotech said.

The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10 pc over the age of 60, with analysis conducted 14 days post 2nd dose.

COVAXIN was developed with seed strains received from the National Institute of Virology and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research, making it a true public, private partnership towards public health.

Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Efficacy against SARS-Cov-2 has been established. COVAXIN has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. COVAXIN is now a global innovator vaccine derived from Research and development from India. The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively”.

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