New Delhi: Hyderabad-based Bharat Biotech on Friday announced that the Lancet peer-review confirmed the efficacy analysis of its Covid-19 vaccine Covaxin. As per phase-three clinical trials data, Covaxin demonstrates 77.8 per cent efficacy against symptomatic COVID-19.
The study by Lancet also found the Covaxin to be 65.2 per cent effective against the more dangerous Delta variant of the coronavirus in its preliminary analysis but said further investigations are necessary to confirm it.
"COVAXIN is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent," the official statement issued by Bharat Biotech said citing the study by the Lancet.
Dr Krishna Ella, Chairman and Managing Director (CMD) of Bharat Biotech said, "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.
Covaxin, which uses traditional, inactivated-virus technology, "induces a robust antibody response" two weeks after two doses are given, The Lancet said in a statement.
The efficacy analysis was based on 130 symptomatic Covid-19 cases among 16,973 participants who were initially seronegative. These cases were recorded at least two weeks after participants had received a second dose.
The medical journal noted that no severe-vaccine-related deaths or adverse events were recorded during a randomized trial involving 24,419 participants aged 18-97 years between November 2020 and May 2021 in India.
The interim study, which was funded by Bharat Biotech and the Indian Council of Medical Research and partly authored by officials at both bodies, is in line with the company's earlier efficacy and safety announcements.
As per reports, the latest study may help end the controversy surrounding the shot's early authorisation in January in India and concerns in some countries.
WHO's Strategic Advisory Group of Experts on Immunization also recommended Covaxin's use in two doses, with an interval of four weeks, in age groups 18 and above. These recommendations are in line with the company's guidance.
The WHO's approval and the Lancet study could also pave the way for India to commit supplies to the COVAX global vaccine sharing effort, which is co-led by the UN body and aims to provide equitable access to shots for low- and middle-income countries.