COVAXIN showed 77.8 per cent efficacy against symptomatic COVID-19: Lancet Study

The Phase-III trial Efficacy and Safety data of COVAXIN got published in the prestigious medical journal The Lancet. The safety profile of Bharat Biotech’s COVAXIN has now been well-established, it showed 77.8 per cent efficacy against symptomatic COVID-19.

Created On: Nov 13, 2021 13:13 IST
COVAXIN Lancet Study, Image: PTI
COVAXIN Lancet Study, Image: PTI

Bharat Biotech’s COVID vaccine COVAXIN showed 77.8 per cent efficacy against symptomatic COVID-19 in its Phase-III trials data published in the prestigious medical journal The Lancet on November 12, 2021. Bharat Biotech had announced Phase-III trials of COVAXIN in November 2020 which was India’s first and largest Phase-III efficacy trials of a COVID-19 vaccine.

The Phase-III trial Efficacy and Safety data of COVAXIN got published in the prestigious medical journal The Lancet just a few days after the World Health Organization (WHO) on November 3, 2021, also granted the Emergency Use Listing (EUL) to India’s first indigenously developed COVID-19 vaccine COVAXIN by Bharat Biotech.

Also read: Where did COVID-19 virus come from? – All You Need to Know

COVAXIN showed 77.8 per cent efficacy against symptomatic COVID-19: Lancet Study

“The data from our product development and clinical trials have been published in 10-peer reviewed journals making COVAXIN one of the most highly published COVID-19 vaccines in the world,” Bharat Biotech Chairman Krishna Ella said in a statement on the Phase III efficacy data being published in The Lancet.

The 10-peer-reviewed journal The Lancet arrived at the COVAXIN vaccine’s efficacy through evaluation of 130 confirmed cases of which 24 were examined under the vaccine group and 106 were examined in the placebo group.

The Lancet peer-reviewed journal noted that Bharat Biotech’s COVAXIN was well-tolerated. The Data Safety Monitoring Board also did not report any safety concerns related to the vaccine. The overall rate of adverse events in the COVAXIN vaccine group was lower than those seen in COVID-19 vaccines. The safety profile of COVAXIN has now been well-established.

Bharat Biotech in a statement noted that COVAXIN is the only COVID-19 vaccine that has demonstrated 65.2 per cent efficacy against Delta variant during the Phase-III Efficacy and Safety trials.

Phase-III trials data of COVAXIN in The Lancet showed: 

•93.4 per cent efficacy against severe symptomatic COVID-19

•77.8 per cent efficacy against symptomatic COVID-19

•63.6 per cent efficacy against asymptomatic COVID-19

•65.2 per cent efficacy against Delta variant of COVID-19

•90.1 per cent efficacy against Kappa variant of COVID-19

•70.8 per cent efficacy against all variants of COVID-19

Phase-III trials data of COVAXIN: Background and Key Details

The Phase-III trial Efficacy and Safety data of COVAXIN was announced by Bharat Biotech on November 16, 2020. The Phase-III trials involved 26,000 volunteers aged 18 years or older from India. It was India’s first and largest Phase-3 efficacy study for a COVID-19 vaccine. The trials were approved by the Drugs Controller General of India (DGCI). The Phase-III trials of COVAXIN had showed 78 per cent efficacy against mild, moderate, and severe COVID-19 infections.

Also read: Bharat Biotech begins phase III trial for COVAXIN

Bharat Biotech’s COVAXIN

COVAXIN is the first indigenous COVID-19 vaccine of India that has been developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The SARS-CoV-2 virus was successfully isolated in a joint effort by NIV, ICMR and Bharat Biotech which led to the development of the virus isolate into an effective COVID-19 vaccine. The inactivated COVID-19 vaccine is developed in the BSL-3 (Bio-Safety Level 3) biocontainment facility of Bharat Biotech.

Also read: Bharat Biotech submits COVAXIN phase 3 trial data to DGCI; expert panel to meet today to review

Also read: Covaxin to be added to UK's approved list of vaccines from November 22

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