Analysis data on the safety and efficacy of Bharat Biotech's vaccine against Covid-19, Covaxin, following its Phase 3 clinical trials, has been peer-reviewed and published in the medical journal, The Lancet.
It came four months after the India-based company demonstrated, in a published pre-print study, that its vaccine against the coronavirus disease had 77.8% efficacy against symptomatic cases and 93.4% against severe symptomatic cases.
According to the study, efficacy data of the whole virion-inactivated vaccine further demonstrates 63.6% protection against asymptomatic disease and 65.2% protection against the B.1.617.2 Delta variant.
"The Lancet peer review confirms the efficacy analysis that demonstrates Covaxin to be effective against Covid-19. Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from Phase 3 clinical trials against the Delta variant at 65.2%," said Bharat Biotech in a statement after The Lancet published the study on Friday.
The efficacy analysis was done after the evaluation of 130 confirmed Covid-19 cases, with 24 observed in the vaccine group as against 106 in the placebo group.
Bharat Biotech developed the anti-Covid jab in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology in Pune.
The company had received strains of Sars-CoV-2 isolated by the Indian government's apex virology laboratory in March 2020.
"The peer review of Covaxin's Phase 3 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," Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement.
"The data from our product development and clinical trials has 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, the ICMR, the National Institute of Virology and the trust imposed by our trial participants who made this happen," Ella said.
The Phase 3 trial efficacy and safety study involved 25,800 volunteers across 25 sites in India. According to the company, Covaxin was well tolerated and the Data Safety Monitoring Board didn't report any safety concerns related to the vaccine.
"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," the company said in its statement.
On November 3, the vaccine was granted emergency-use listing by the World Health Organization (WHO), giving various countries to expedite their own regulatory nods to import Covaxin vials.
Balram Bhargava, director general of the ICMR, said, "Following successful isolation of the Sars-CoV-2 virus at the ICMR-National Institute of Virology in Pune, the 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 3 efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. It speaks highly about the strong position of Covaxin among other global front-runners [with respect to] Covid-19 vaccines. 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."
According to the company, its emergency-use authorisation application is in process in at least 50 countries.
"With more than 150 million doses manufactured and 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 among children aged 2-18, with results available during Q4 this year. Bharat Biotech is poised to achieve its goal of an annualised capacity of 1 billion doses of Covaxin by the end of 2021," the company said in its statement.