Covaxin, India's indigenous vaccine against COVID-19 demonstrated "overall interim clinical efficacy" of 78 per cent and 100 per cent efficacy against "severe COVID-19 disease" in Phase-III trials, informed Bharat Biotech and Indian Council of Medical Research (ICMR) on Wednesday.
"Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 per cent against mild, moderate and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100 per cent with an impact on reduction in hospitalizations," read the release by the Bharat Biotech.
"The efficacy against asymptomatic COVID-19 infection was 70 per cent, suggesting decreased transmission in Covaxin recipients. Safety and Efficacy Results from the final analysis will be available in June," it added.
According to Bharat Biotech, the Phase-III study enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60, with analysis conducted 14 days after the second dose.
Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.
Dr 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," he said.
Professor Balram Bhargava, Secretary, Director General, ICMR said that The first indigenous COVID-19 vaccine developed by ICMR and BBIL, has shown the efficacy of 78 per cent in the second interim analysis.
"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," he said.
Several million doses of Covaxin have been supplied and administered in India and several other countries. The vaccine was approved and introduced initially through Emergency Use Authorization (EUA) under the clinical trial mode, resulting in robust safety data in real-life conditions.
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, "Covaxin's evidence-based development has proved its suitability for global access, with excellent efficacy results against symptomatic, asymptomatic and severe disease. The interest from countries worldwide has quietly validated our efforts. We thank our volunteers, principal investigators, partners and team Bharat Biotech for their contribution to this project towards improving Global Public Health."
The company has set a target of producing 700 million doses per year and been scaling up its capacity in its multiple facilities in Hyderabad and Bengaluru.
According to the Union Health Ministry, the cumulative number of COVID-19 vaccine doses administered in the country stands at 13,01,19,310 as of Wednesday.
Besides Covaxin, India approved the EUA for two other vaccines Covishield and Sputnik V for its inoculation programme against COVID-19.
From April 2, the government started vaccinating all people above 45 years. India started its vaccination drive on January 16 with priority given to all healthcare and frontline workers in the first phase. The second phase started on March 1 where doses were administered to people above the age of 60 and those between 45 and 59 years with specific comorbidities.
( With inputs from ANI )
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