Indian Council of Medical Research (ICMR) has said that the interim efficacy results of Bharat Biotech's COVID-19 vaccine, Covaxin, showcases the immense strength of 'Atmanirbhar Bharat' to fight the odds and stand tall in the global public health community.
The vaccine is the result of a partnership between ICMR and Bharat Biotech International Limited (BBIL).
"The bench-to-bedside journey of completely indigenous COVID-19 vaccine in less than 8 months' time showcases the immense strength of Atmanirbhar Bharat. It is also a testament to India's emergence as a global vaccine superpower," said Dr Balram Bhargava, Director General, ICMR.
The Phase 3 trial, jointly initiated by ICMR and BBIL in mid-November 2020, was conducted with 25,800 individuals across 21 sites. "The interim efficacy trend of 81 per cent, analysed as per the protocol approved by the DCGI [Drugs Controller General of India], puts it at par with other global front-runner vaccines," stated ICMR.
Covaxin is the first COVID-19 vaccine that has been developed completely in India. In March 2020, following successful isolation of the SARS CoV-2 virus, ICMR entered into a public-private partnership with BBIL to develop the virus isolate into an effective vaccine candidate.
ICMR-National Institute of Virology (NIV) characterised 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 high safety profile of the candidate vaccine with seroconversion rates of 98.3 per cent and 81.1 per cent on day 56 and 104, respectively, ICMR said.
The institution also said that Covaxin has been developed on the WHO prequalified vero cell platform, which is globally recognised with a well-established track record of safety. Covaxin's ability to neutralise UK variant strain of SARS-CoV-2 has also recently been established.
"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," said Dr Samiran Panda, Head, Epidemiology and Communicable Disease, ICMR and Director, National AIDS Research Institute.