New Delhi, Mar 3 (PTI) The phase 3 results of Covaxin, developed by Indian Council of Medical Research (ICMR) in partnership with Bharat Biotech International Limited (BBIL), has shown an interim vaccine efficacy of 81 per cent in preventing COVID-19, the apex health research body said on Wednesday.

The phase 3 trial, jointly initiated by ICMR and BBIL in mid-November 2020, was conducted on a total of 25,800 individuals across 21 sites. 

The interim efficacy trend of 81 per cent, analyzed as per the protocol approved by the 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 Dr Balram Bhargava, Director General, ICMR. 

Covaxin is the first COVID-19 vaccine that has been developed completely in India.

"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman & Managing Director Krishna Ella said.

In March 2020, following the successful isolation of the SARS-CoV-2 virus at  National Institute of Virology (NIV), the ICMR entered into a public-private partnership with BBIL to develop the virus isolate into an effective vaccine candidate.

The ICMR-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, the research body said.

Further studies conducted in rhesus macaques also established remarkable safety and protective efficacy of Covaxin. 

The phase 1 and phase 2 clinical trials conducted in 755 participants demonstrated a 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.

Covaxin has been developed on the WHO prequalified vero cell platform which is globally recognized with a well-established track record of safety, the ICMR said.

Covaxin's ability to neutralize the UK variant strain of SARS-CoV-2 has also recently been established, it 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," said Dr Samiran Panda, Head, Epidemiology and Communicable Disease, ICMR and Director, National AIDS Research Institute.

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