After Bharat Biotech's Covaxin showed 81 per cent efficacy in the phase three trial results, the company's Chairman Krishna Ella took a dig at those who had earlier questioned the credibility of the vaccine.
In a video message, Ella said: "Remembering people criticising us saying our data is not transparent, not in the public domain, I am today proud to say that our data are in the public domain in six publications. If people have got patience, they should read those articles".
On Wednesday, Bharat Biotech published the interim efficacy report of phase 3 clinical trial on its COVID-19 vaccine, officially known as Covaxin. The indigenous COVID-19 vaccine is found to be 81 per cent effective in preventing the virus. The phase 3 trial, jointly initiated by ICMR and Bharat Biotech in mid-November 2020, was conducted on a total of 25,800 individuals across 21 sites.
However, the interim result was based on 43 cases, of which 36 cases were observed in the placebo group and the other seven were observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 per cent. Despite that, the vaccine earned restricted emergency use approval. At that time, several ministers and doctors raised questions over administering Covaxin to healthcare workers and frontline workers. Questions were also raised on how in the second phase of vaccination people can be charged for a shot that is still under trial.
The final trial report of Covaxin's efficacy got published on Wednesday. Dr Balram Bhargava, Director General, ICMR hailed the trial results and said: "The bench-to-bedside journey of completely indigenous COVID-19 vaccine in less than 8 months' time showcases the immense strength of Atmanirbhar Bharat to fight the odds and stand tall in the global public health community".
Bhargava added that the results are a testament to India's emergence as a global vaccine superpower. Covaxin is the first COVID-19 vaccine that has been developed completely in India.
Last year in March, the National Institute of Virology (NIV), and the ICMR entered into a public-private partnership with Bharat Biotech to develop a vaccine candidate against coronavirus. The ICMR-NIV characterised the vaccine developed by Bharat Biotech 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. Later, the phase 1 and phase 2 clinical trials, which were conducted on 755 participants, demonstrated a high safety profile of the candidate vaccine, according to the company.
The country's first indigenously developed COVID-19 vaccine has also shown the ability to neutralise the UK variant strain of SARS-CoV-2. Recently, Prime Minister Narendra Modi also took the Covaxin vaccine at Delhi's AIIMS hospital when phase 2 of the vaccination drive began on March 1.
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