Phase 3 Clinical Trial of COVAXIN shows 81% efficacy
COVAXIN is the first COVID-19 vaccine that has been developed completely in India
The results of phase 3 clinical trial of COVAXIN, which the Indian Council of Medical Research (ICMR) has developed in partnership with Bharat Biotech, has shown an interim vaccine efficacy of 81% in preventing COVCOVID-19.
The phase 3 clinical trial was jointly initiated by ICMR and Bharat Biotech International Limited in mid-November 2020.
The trial has been conducted on a total of 25,800 individuals across 21 sites, ICMR announced on Wednesday.
The interim efficacy trend of 81%, analyzed as per the protocol approved by the Drugs Controller General of India (DCGI), puts it at par with other global front-runner vaccines.
“The bench-to-bedside journey of completely indigenous COVID-19 vaccine in less than 8 months’ time showcases the immense strength of Atmanirbhar Bharat (self-reliant India) to fight the odds and stand tall in the global public health community. It is also a testament to India’s emergence as a global vaccine superpower,” said Director General, ICMR Balram Bhargava in a statement.
The Head of Epidemiology and Communicable Disease, ICMR and Director, National AIDS Research Institute Samiran Panda said, “The development and deployment of COVAXIN ensures that India has a powerful weapon in its arsenal in a continually evolving pandemic situation and will go a long way in helping us win the war against COVID-19. The need of the hour is to ensure that people in India continue to receive the vaccine and break the chain of virus transmission.”
COVAXIN is the first COVID-19 vaccine that has been developed completely in India.
In March 2020, following the successful isolation of the SARS CoV-2 virus at ICMR-National Institute of Virology (NIV), ICMR entered into a public-private partnership with BBIL to develop the virus isolate into an effective vaccine candidate.
ICMR-NIV characterized the vaccine developed by BBIL through in-vitro experiments and electron microscopy studies.
Pre-clinical studies in small animals and hamsters showed promising results in terms of safety and immunogenicity.
Further studies conducted in rhesus macaques also established remarkable safety and protective efficacy of COVAXIN.
Phase 1 and Phase 2 clinical trials conducted in 755 participants demonstrated a high safety profile of the candidate vaccine with sero-conversion rates of 98.3% and 81.1% on day 56 and 104 respectively.
COVAXIN has been developed on the WHO prequalified verocell platform, which is globally recognized with a well-established track record of safety. COVAXIN’s ability to neutralize the UK variant strain of SARS-CoV-2 has also recently been established.