The safety and efficacy analysis data from Phase III clinical trials of Bharat Biotech's Covid19 vaccine, Covaxin, is peer reviewed and has been published in The Lancet.

The Lancet peer-review ‘confirms’ the efficacy analysis which demonstrates Covaxin to be effective against Covid 19. Covaxin is the only Covid19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent, Bharat Biotech said on Friday.

“The peer-review of Covaxin phase III clinical trial data in The Lancet , an authoritative voice in global medicine, validates our commitment to data transparency and meeting the stringent peer-review standards of world leading medical journals,'' Krishana Ella, Chairman and Managing Director, Bharat Biotech said in a release.

``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,'' he added.

Hyderabad-based Bharat Biotech developed the vaccine in association with Indian Council of Medical Research (ICMR).

Describing it as one of the `most successful' public private partnership Balram Bhargava, Director General, ICMR) said: ``I am delighted to see that the phase III efficacy data has also been published in The Lancet, This itself speaks high about the strong position of Covaxin amongst other global front-runners Covid19.''

The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India’s largest ever clinical trial conducted for a Covid-19 vaccine.

‘Well tolerated vaccine’

Covaxin was `well tolerated' and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine. The overall rate of adverse events observed in Covaxin was lower than that seen in other Covid-19 vaccines.

Recently, the World Health Organization granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide.

Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.

The efficacy analysis demonstrated Covaxin to be 77.8 per cent effective against symptomatic Covid19 through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group and it is 93.4 pc effective against severe symptomatic covid ,

The safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events

While it confirms 63.6 per cent protection against asymptomatic Covid19, the data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta, the company said.

With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the Covid19 pandemic.

It is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results available during Q4 2021.

Bharat Biotech is poised to achieve its goal of an annualised capacity of about one billion doses of Covaxin by the end of 2021.

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