The coronavirus vaccine developed by Bharat Biotech is ‘highly efficacious’ and presents no safety concern, according to a new study by the medical journal The Lancet. Covaxin has demonstrated that it is 77.8 per cent effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group, Phase III data published in The Lancet said on Friday. Covaxin “induces a robust antibody response” two weeks after two doses are given, it added.
The efficacy data which was peer reviewed also said the vaccine demonstrated 63.6 per cent protection against asymptomatic Covid-19 and 65.2 per cent safety against the Delta variant besides showing 70.8 per cent guard against all variants of SARS-CoV-2 virus.
The efficacy analysis demonstrated that Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19.
“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. 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,” Bharat Biotech Chairman Krishna Ella said in a statement.
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.
Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said, following successful isolation of the SARS-CoV-2 virus at NIV, ICMR and Bharat Biotech embarked upon one of the most successful public-private partnerships 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 itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines,” Bhargava said.
The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of “Atmanirbhar Bharat” along with the Indian academia and industry in fighting against the odds and carving a niche in the global community, he added.
Recently, the World Health Organisation granted emergency use listing to Covaxin, enabling countries to expedite their regulatory approval to import and administer doses.
The jab has also received emergency use authorisations 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, the statement said.
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 annualised capacity of about 1.0 billion doses of the jab by the end of 2021.
(with agency inputs)