Phase-3 clinical trial data of BBIL’s Covaxin 77.8 pc effective against Covid : Lancet

Hyderabad : Lancet, one of the highest impact factors in the field of medicine has stated that the peer-review of Covaxin Phase-III clinical trial data of Bharat Biotech International Limited (BBIL) has demonstrated 77.8 per cent effective against symptomatic Covid-19.

Bharat Biotech, a global leader in vaccine development and innovation, announced on Friday that the safety and efficacy analysis data from Phase III clinical trials of COVAXIN is peer reviewed and published in the Lancet.

Just a few days after the World Health Organisation (WHO) granted Emergency Use Listing (EUL) to India’s indigenous vaccine ‘Covaxin’, the Lancet peer-review confirmed the efficacy analysis which demonstrates COVAXIN to be effective against COVID-19.

Covaxin’s efficacy was arrived at through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.

It also stated that efficacy analysis demonstrates COVAXIN to be 93.4 percent effective against severe symptomatic COVID-19.

Safety analysis demonstrates adverse events reported were similar to placebo, with 12 percent of subjects experiencing commonly known side effects and less than 0.5 percent of subjects experiencing serious adverse events, the Medical journal stated.

India’s indigenous vaccine, COVAXIN was developed by Bharat Biotech partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune.

In a release, Hyderabad-based Bharat Biotech Chairman and Managing Director Dr. Krishna Ella, said,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.

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 said.

This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, Indian Council of Medical Research, National Institute of Virology, and the trust imposed by our trial participants who made this happen, he said.

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, he said 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 Covid-19 vaccines. The safety profile of COVAXIN is now well established based on inactivated vaccines technology, and in large part due to the extensive 25-year safety track record of Bharat Biotech’s vero cell manufacturing platform, he added.

ICMR Director General Dr. Balram Bhargava, said, “Following successful isolation of the SARS-CoV-2 virus at ICMR -National Institute of Virology (NIV), Pune, ICMR and Bharat Biotech International Limited (BBIL) embarked upon one of the most successful public-private partnership to develop the virus isolate into an effective COVID-19 vaccine.

I am delighted to see that the phase III efficacy data has also been published in THE LANCET, one of the most reputed journals worldwide. This speaks high about the strong position of COVAXIN amongst other global front-runners COVID-19 vaccines, he said.

Recently, the WHO 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.

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 COVID-19 pandemic.

COVAXIN 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 annualized capacity of 1.0 billion doses of COVAXIN by the end of 2021.

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