Phase 3 clinical trial of COVAXIN shows 81 per cent efficacy: Bharat Biotech

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.

Created On: Mar 4, 2021 11:25 ISTModified On: Mar 16, 2021 17:48 IST
COVAXIN shows 81% efficacy

The Indian Council of Medical Research informed on March 3, 2021, that the results of phase 3 clinical trial of COVAXIN, which ICMR has developed in partnership with Bharat Biotech, has shown an interim vaccine efficacy of 81% in preventing COVID-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.

The interim efficacy trend of 81%, analyzed according to the protocols Drugs Controller General of India, has put the indigenously developed vaccine at par with other global front-runner vaccines.

Reported data available of all the 3 clinical trials of COVAXIN:

The Chairman and Managing Director of Bharat Biotech Krishna Ella said that it is an important milestone in vaccine discovery, for science as well as in our fight against Coronavirus.

He further mentioned that with the results of Phase 3 clinical trials of COVAXIN, the company has now reported data on the indigenous vaccine from Phase 1, 2, and 3 clinical trials which involved around 27,000 participants.

Dr. Balram Bhargava, Director-General, ICMR while talking about the successful results stated that the bench-to-bedside journey of India’s first indigenous COVID-19 vaccine in less than 8 months has showcased the immense strength of Atmanirbhar Bharat in fighting the odds and stand tall in the global public health community. He added that it is also a testament to the country’s emergence as a global vaccine superpower.

COVAXIN: India’s first indigenously developed vaccine

COVAXIN is the first Coronavirus vaccine that has been developed completely by India. After the successful isolation of the SARS-CoV-2 virus at the National Institute of Virology- NIV, in March 2020, the ICMR had entered into a public-private partnership with Bharat Biotech in order to develop the virus isolate into an effective vaccine candidate.

The vaccine developed by Bharat Biotech was characterized by ICMR- NIV through in-vitro experiments and electron microscopy studies.

According to the research body, the pre-clinical trials of the vaccine in hamsters and small animals had shown promising results in terms of immunogenicity and safety.

Studies assured safety and efficacy of COVAXIN:

Further studies conducted in rhesus macaques had established the protective efficacy and remarkable safety of the vaccine.

The phase 1 and 2 clinical trials that were conducted in 755 participants had demonstrated a high safety profile of COVAXIN with seroconversion rates of 98.3% and 81.1% on days 56 and 104.

INCR informed that India’s vaccine has been developed on the WHO prequalified Vero cell platform which has also been globally recognized with a well-established track record of safety.

It further added that COVAXIN’s ability to neutralize the UK variant strain of SARS-CoV-2 has also been established.

Indians must continue to receive the vaccine:

The development and the deployment of Coronavirus vaccine COVAXIN has ensured that India has a powerful weapon with it in a continually evolving pandemic situation and will go a long way to help in winning the war against the crisis.

The need of the hour is to ensure that the citizens of India must continue to receive the Coronavirus vaccine and help in breaking the chain of virus transmission.

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