India’s indigenous vaccine COVAXIN has showed an efficacy of 77.8 per cent in symptomatic Covid-19 cases in phase 3 clinical trials.
Bharat Biotech announced safety and efficacy analysis data from phase 3 clinical trials of COVAXIN today. COVAXIN has been developed by Bharat Biotech in partnership with Indian Council of Medical Research and National Institute of Virology.
The trials were conducted across 25 sites across the country on 25 thousand 800 volunteers of the age group of 18 to 98 years. COVAXIN has showed an efficacy rate of 93 per cent against severe Covid-19 disease and 65 per cent efficacy against Delta variant.
Expressing happiness over the clinical trials result, Director General of Indian Council of Medical Research, Balram Bhargava has said, Covaxin has demonstrated an overall efficacy rate of 77.8 per cent in India’s largest COVID phase 3 clinical trials. He said, scientists of ICMR and Bharat Biotech have worked tirelessly to deliver a truly effective vaccine of highest international standards.
He said, Covaxin will not only benefit the Indian citizens but would also immensely contribute in protection of the global community against the pandemic. He also expressed happiness that Covaxin works well against all variant strains of Covid19.
Chairperson& Managing Director of Bharat Biotech, Dr. Krishna Ella has said that the conducting of the largest ever Covid vaccine trials in India establishes the ability of the country.
In a statement, Bharat Biotech has said, COVAXIN was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine. It said, continued improvement of Covaxin is underway with additional clinical trials to establish safety and efficacy in children between 2 to 18 years of age. It said, a clinical trial to determine the safety and immunogenicity of a booster dose is also in process.
Bharat Biotech said, COVAXIN has been evaluated through neutralizing antibody responses against several variants of concern, namely Delta, Kappa, Alpha, Beta and Gamma. It said, the data from these studies have been extensively published in peer
reviewed journals and available for review in the public domain.
COVAXIN has received the emergency use authorizations in 16 countries. The company is in discussions with World Health Organization to obtain emergency Use Listing for COVAXIN.