“COVAXIN approval for emergency use is a major leap forward in innovation and new product development in India,” said Dr. Krishnaela, Chairman and Managing Director of Bharat Biotech.
Ella said in a statement, delighted with the announcement by the Ministry of Health and Family Welfare and the statement today that the DCGI-Central Standards Control Organization has granted an emergency use authorization for the Covid-19 vaccine. It is a major milestone in India’s scientific capabilities and a kickstart to India’s innovation ecosystem. This vaccine addresses the unmet medical needs during this pandemic, but our goal is to provide global access to those who need it most. COVAXIN has generated excellent safety data with a strong immune response to persistent viral proteins. “
“The development of COVAXIN was a public-private partnership between ICMR, NIV and Bharat Biotech. We would like to thank Dr. Balram Bhargava, Executive Director of ICMR, for his visionary leadership in this project,” he said. ..
The Subject Expert Committee of the Central Pharmaceutical Standards Administration has made recommendations for consideration and final decision by the Director of Pharmaceutical Management in India.
COVAXIN is a highly purified and inactivated 2-dose SARS-CoV2 vaccine manufactured on a Vero cell production platform with an excellent safety record of over 300 million doses.
COVAXIN Phase III clinical trial
COVAXIN’s Phase III human clinical trial will begin in mid-November and is targeted to be conducted by 26,000 volunteers across India. This is India’s first and only Phase III efficacy study for the COVID-19 vaccine and the largest Phase III efficacy study ever conducted. Indian vaccine. It has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials and is expected to have safety and immunogenicity results.
Developed in collaboration with the Indian Medical Research Council (ICMR)-National Institute of Virology (NIV), COVAXIN is a unique product developed and manufactured at Bharat Biotech’s BSL-3 (Biosafety Level 3) biocontainment facility. It is an inactivated vaccine. That kind of in the world.
The COVAXIN evaluation provided several unique product characteristics, including a long-lasting immune response to multiple viral proteins, not just spike proteins. It showed broad-spectrum neutralizing ability in heterologous SARS-CoV2 strains and therefore potentially reduced or eliminated escape mutants. It has also been shown to generate memory T cell responses to its multiple epitopes, demonstrating longevity and rapid antibody response to future infections. Its most important feature is its proven safety profile, which is significantly lower than some other vaccines with published data.
Based on data from product development and clinical trials to date, five publications have been produced and submitted to international peer-reviewed journals. Four of them have been approved and will be published shortly. The publication of Phase II study data is subject to a peer review process.
As part of the regulatory guidelines, all data has been submitted to DCGI and CDSCO.
COVAXIN approval is a big leap forward in innovation: Bharat Biotech CMD Krishna Ella
https://www.thehindubusinessline.com/companies/covaxin-approval-a-giant-leap-for-innovation-bharat-biotech-cmd-krishna-ella/article33485954.ece COVAXIN approval is a big leap forward in innovation: Bharat Biotech CMD Krishna Ella